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ACTA OPHTHALMOLOGICA

THESIS
http://www.actaophthalmologica.com

Thesis

Recovery after cataract surgery

Studies on postoperative recovery and outcome after cataract surgery

Susanna Porela-Tiihonen
Department of Anaesthesiology and Department of Intensive Care Medicine,
Kuopio University Hospital, University of Eastern Finland, Kuopio
ACTA OPHTHALMOLOGICA 2016

Preface

This thesis was first published (in print only) by the University of Eastern Finland as: Dissertations in Health Sciences
number 275; 2015; Kuopio, Finland; ISBN (print): 978-952-61-1726-3; ISBN (pdf): 978-952-61-1727-0;
ISSN (print): 1798-5706; ISSN (pdf): 1798-5714; ISSN-L: 1798-5706.

It was presented by permission of the Faculty of Health Sciences, University of Eastern Finland for
public examination in Auditorium 2, Kuopio University Hospital, Kuopio, on Friday, April 10th 2015, at 12 noon

Author’s address: Department of Anaesthesiology and Department of Intensive Care Medicine


Kuopio University Hospital
University of Eastern Finland
KUOPIO
FINLAND

Supervisors: Professor Hannu Kokki, M.D., Ph.D.


Department of Anaesthesiology and Department of Intensive Care Medicine
University of Eastern Finland
KUOPIO
FINLAND

Professor Kai Kaarniranta, M.D., Ph.D.


Department of Ophthalmology
University of Eastern Finland
KUOPIO
FINLAND

Docent Merja Kokki, M.D., Ph.D.


Department of Anaesthesiology and Department of Intensive Care Medicine
University of Eastern Finland
KUOPIO
FINLAND

Reviewers: Professor Anders Behndig, M.D., Ph.D.


Department of Ophthalmology
Umeå University
UMEÅ
SWEDEN

Docent Annika Takala, M.D., Ph.D.


Department of Anaesthesiology
University of Tampere
TAMPERE
FINLAND

Opponent: Professor Juha Holopainen, M.D., Ph.D.


Department of Ophthalmology
University of Helsinki
HELSINKI
FINLAND

To my family
aos_94_A2_Acknowlegements_Layout 1 02-04-2016 11:32 Page 1

ACTA OPHTHALMOLOGICA 2016

Acknowledgements
This study was carried out in the Department of Anesthesiology, Department of Intensive Care Medicine and Department of
Ophthalmology, School of Medicine, University of Eastern Finland and Department of Ophthalmology, Kuopio University Hospital,
during the years 2009-2015.
I would like to express my gratitude to all of the individuals who have participated in this work. I feel myself privileged to have had you
in my life.
I present my deepest gratitude to my principal supervisor Professor Hannu Kokki. The original idea devised by Professor Kokki was the
foundation for the present study, in addition to his exceptional expertise in the study of pain and recovery. Without the impressive
knowledge and willingness to help of Professor Kokki, this work would never have been started, advanced, or completed.
I am grateful for having been able to undertake my thesis under the supportive guidance of Professor Kai Kaarniranta. The excellent
expertise in the field of ophthalmology and science in general provided by Professor Kaarniranta has been invaluable in this work. I am
truly thankful for all the priceless encouragement and support.
I want to express my gratitude to my third supervisor Docent Merja Kokki for the support and excellent advice, which played such an
essential role in this project. I am thankful and pleased for all the kind help and flexibility during these years.
Through your enthusiasm and impressive experience on research and medical practice, you have all provided this work and my life with
inspiration. You were always there for me when I needed help, and I feel privileged to have enjoyed your trust and faith in me as a young
researcher. In addition, your positive attitude makes it a pleasure to work with you. I could have never hoped for better supervisors.
I want to warmly thank Professor emeritus Harri Sintonen for participating in this study. The exceptional knowledge of Professor
Sintonen on health-related quality of life research was invaluable in coping with our study issues. I send my sincere thanks to Professor
Risto Roine for all the essential help and advice on treatment outcome issues. I am deeply grateful to have had a possibility to include
this much expertise in this work.
I am thankful for the collaboration and advice of Sinikka Purhonen MD, PhD; many thanks for all the support and encouragement.
The reviewers of this thesis work, Professor Anders Behndig and Docent Annika Takala, are warmly acknowledged for their construc-
tive and encouraging comments. Their excellent expertise helped to improve this work further.
Many warm thanks need to be expressed to Helvi Käsnänen RN for the help with the study participants. I am deeply grateful to staff of
the cataract surgery unit in Kuopio University Hospital for the kind help with the study questionnaires. I wish to thank Tommi
Karttunen MD for the practical advice concerning cataract surgery. I send my thanks to statistician Tuomas Selander and to Esa Kokki
PhD for the help with the statistics. I also want to acknowledge Ewen McDonald PhD for the linguistic revision of the thesis.
I wish to thank my dear friends, who are so wonderful. I appreciate and enjoy our time together. There are also many other important
people who have helped and supported me during this work. In addition, I send my most sincere thanks to all the study participants.
Finally, I can never thank enough my nearest and dearest, my parents and my family.
Thank you my mother Laimi and my father Olavi for the neverending support and encouragement. You always have the right words to
say, and without your faith in me, I would not be here. Special thanks go to my lovely little ones, our daughter Veera and our baby boy
Elias. I feel blessed to be your mother.
Jukka, I thank you for sharing life with me, and making me a happy wife and a proud mother to our children. Thank you for your
support and patience during this work. Without your help, I would have never been able to finish this project.
This work was financially supported by governmental EVO funding of the Hospital District of Northern Savo and by the University of
Eastern Finland, Kuopio, Finland and The Finnish Medical Foundation, which are gratefully acknowledged.
aos_94_A2_List of Paper_Layout 1 12-04-2016 11:46 Page 1

ACTA OPHTHALMOLOGICA 2016

List of papers
This dissertation is based on the following original publications:

Paper I

Porela-Tiihonen S, Kaarniranta K, Kokki H. Postoperative pain after cataract surgery. J Cataract Refract Surg. 39(5):789–98, 2013

Paper II

Porela-Tiihonen S, Kaarniranta K, Kokki M, Purhonen S, Kokki H. A prospective study on postoperative pain after cataract surgery. Clin
Ophthalmol. 7:1429–35, 2013

Paper III

Porela-Tiihonen S, Kaarniranta K, Kokki M, Kokki H. Recovery and patient satisfaction after cataract surgery. A one-year prospective
follow-up study. Acta Ophthalmol. 93:e172–3, 2015

Paper IV

Porela-Tiihonen S, Roine RP, Sintonen H, Kaarniranta K, Kokki M, Kokki H. Health-related quality of life after cataract surgery with
phacoemulsification technique and intraocular lens implantation. Acta Ophthalmol. 94:21–25, 2016

The publications have been adapted with the permission of the copyright owners.
aos_94_A2_List of abbreviations_Layout 1 02-04-2016 11:49 Page 1

ACTA OPHTHALMOLOGICA 2016

List of abbreviations
15D 15-Dimensional Instrument of Health-Related Quality of Life

ASCRS American Society of Cataract Refractive Surgery

BAK Benzalkonium chloride

BPI Brief Pain Inventory

BUT Tear-film break-up time

CME Cystoid macular oedema

EQ-5D The EuroQol Group Association Five Domain Quality of Life Questionnaire

ESCRS European Society of Cataract Refractive Surgery

HRQoL Health-related quality of life

HUI The Health Utility Index instrument

IASP International Association for the Study of Pain

IOL Intraocular lens

IOP Intraocular pressure

NEI-VFQ The National Eye Institute Visual Function Questionnaire

NHP The Nottingham Health Profile

NRS Numerical Rating Scale

NSAID Non-steroidal anti-inflammatory drug

QALY Quality-Adjusted Life Year

QWB-SA The Quality of Well-Being Scale-Self Administered Version

RCT Randomized controlled trial

SF The Short Form Health Survey

SIP Sickness Impact Profile

VA Visual acuity

VEGF Vascular endothelial growth factor

VF Visual functioning

VF- Visual Functioning Index- Questionnaire

VAS Visual Analogue Scale

VRS Verbal Rating Scale

YAG Yttrium aluminium garnet


aos_92_A2_contents_Layout 1 07-04-2016 08:07 Page 1

ACTA OPHTHALMOLOGICA 2016

Contents

PREFACE II 4.3.4 Management of pain 14


ACKNOWLEDGEMENTS III 4.3.4.1 Analgesic efficacy of the drugs used in
postoperative care 14
LIST OF PAPERS IV 4.3.4.2 Adverse effects 14
ABBREVIATIONS V 4.3.4.3 Non-steroidal anti-inflammatory agents 14
4.3.4.4 Corticosteroids 15
ABSTRACT 1
4.4 Discussion 15
1 INTRODUCTION 2 4.5 References 15
2 REVIEW OF THE LITERATURE 2 5 A PROSPECTIVE STUDY ON POSTOPERATIVE
2.1 Recovery after cataract surgery 2 PAIN AFTER CATARACT SURGERY 17
2.1.1 Common recovery 2 5.1 Introduction 18
2.1.2 Postoperative care 3
5.2 Materials and methods 18
2.1.3 Possible complaints 4
5.3 Statistic 19
2.2 Ocular symptoms after cataract surgery 5
2.2.1 Pain and other ocular symptoms 5 5.4 Results 19
2.2.2 Symptoms during the first hours after surgery 6 5.4.1 Patient characteristics 19
2.2.3 Symptoms during the first days after surgery 6 5.4.2 Pain 19
2.2.4 Symptoms during the first weeks after surgery 7 5.4.3 Other ocular symptoms 20
5.4.4 Analgesics 20
2.3 Outcome and satisfaction after surgery 7
2.3.1 Measuring vision-related outcome 7 5.5 Discussion 21
2.3.2 Satisfaction with treatment outcome 8 5.6 Conclusions 22
2.4 Cataract surgery and health-related quality of life 8 5.7 Acknowledgements 22
2.4.1 Measuring health-related quality of life 8 5.8 Author contributions 22
2.4.2 Generic instruments of health-related 5.9 Disclosure 22
quality of life 8 5.10 References 22
2.4.3 Health-related quality of life after cataract surgery 9 6 RECOVERY AND PATIENT SATISFACTION
3 AIMS OF THE STUDY 9 AFTER CATARACT SURGERY. A ONE-YEAR
PROSPECTIVE FOLLOW-UP STUDY 22
4 POSTOPERATIVE PAIN AFTER CATARACT 6.1 A letter to the editor 22
SURGERY 9 6.2 References 23
4.1 Introduction 9
4.2 Methods 9 7 HEALTH-RELATED QUALITY OF LIFE
4.2.1 Search strategy 9 AFTER CATARACT SURGERY WITH
4.2.2 Selection criteria, types of studies 10 PHACOEMULSIFICATION TECHNIQUE AND
4.2.3 Types of participants 10 INTRAOCULAR LENS IMPLANTATION 23
4.2.4 Types of interventions 10 7.1 Introduction 24
4.2.5 Selection of studies 10 7.2 Materials and methods 24
4.2.6 Data extraction and analysis 10 7.3 Statistics 25
4.2.7 Risk of bias in included studies 12 7.4 Results 25
4.3 Results 12 7.5 Discussion 26
4.3.1 Study descriptions 12 7.6 Acknowledgements 27
4.3.2 Incidence and prevalence of postoperative 7.7 References 27
pain 13
8 GENERAL DISCUSSION 28
4.3.2.1 Pain in the hospital during the first hours
after surgery 13 8.1 Summary 28
4.3.2.2 Pain after discharge 13 8.2 Limitations of the present study 28
4.3.3 Severity of pain 14 8.3 Future directions 28
4.3.3.1 Severity of postoperative pain during 9 CONCLUSIONS 30
early recovery 14
10 SUMMARY IN FINNISH 30
4.3.3.2 Severity of postoperative pain after
discharge 14 11 REFERENCES 30
Acta Ophthalmologica 2016

Thesis

Recovery after cataract surgery


Susanna Porela-Tiihonen,1 Hannu Kokki,1 Kai Kaarniranta2 and Merja Kokki1
1
Department of Anaesthesiology and Department of Intensive Care Medicine, Kuopio University Hospital, University of Eastern
Finland, Kuopio, Finland
2
Department of Ophthalmology, Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland

ABSTRACT.
Cataract surgery is the most common ophthalmological surgical procedure, and
it is predicted that the number of surgeries will increase significantly in the
future. However, little is known about the recovery after surgery. The first aim of
this study was to evaluate the prevalence, severity and duration of pain and other
ocular discomfort symptoms experienced after cataract surgery. The other
objectives were to identify the factors associated with lower postoperative patient
satisfaction and to measure the effect of cataract surgery on patients’ health-
related quality of life (HRQoL) and visual function in everyday life. The study
design was a prospective follow-up study. The course of the recovery and the
presence of ocular symptoms were evaluated by interviewing the patients via a
questionnaire at 1 day, 1 week, 6 weeks and one year after surgery The visual
functioning in everyday life was measured with Visual Functioning Index VF-7
and Catquest-9SF-questionnaires and furthermore the HRQoL was measured
with the 15D-instrument before surgery and at 12 months after surgery.The
patients returned the questionnaires by mail and were interviewed in the hospital
on the day of the surgery. The same patients filled-in all the questionnaires. The
patient reports were used to collect the data on medical history. A total of 303
patients were approached at Kuopio University Hospital in 2010–2011 and of
these 196 patients were eligible and willing to participate, with postoperative
data being available from 186 (95%) patients. A systematic review article was
included in the study procedure and it revealed the wide range in the reported
incidence of postoperative ocular pain. Some of the identified randomized
controlled studies reported no or only minor pain whereas in some studies
significant pain or pain lasting for several weeks has been described in more than
50% of the study patients. In the present study setting, pain was reported by
34% during the first postoperative hours and by approximately 10% of patients
during the first six weeks after surgery. During the early recovery in the hospital,
only a minority of the patients reporting pain were provided with pain
medication. The ocular discomfort symptoms such as itchiness, burning,
foreign-body sensation and tearing were common both before (54%) and after
surgery (38–52%). These symptoms can also be described as painful symptoms
and are often difficult to distinguish from ocular pain. The symptoms are also
typical of ocular surface disease, and some patients may benefit from the
postoperative administration of tear substitutes. The patients reporting postop-
erative ocular symptoms were less satisfied with the treatment outcome at
12 months after surgery (p = 0.001) compared to the patients who experienced
no symptoms. Those patients reporting less disability in visual functioning before
surgery were more satisfied than patients with more reported disability.The
HRQoL improved significantly after cataract surgery (p = 0.002). However,
when compared to an age-and gender-standardized control population, in

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Acta Ophthalmologica 2016

cataract subjects the HRQoL remained slightly worse both before and at
12 months after surgery.

Acta Ophthalmol. 2016: 94, thesis 2: 1–34


ª 2016 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd

doi: 10.1111/aos.13055

nique which was initially developed in be used in the assessment of patient-


1. Introduction 1967 is based on high-energy ultra- reported outcomes. The evaluation of
Cataract is an ocular condition that sound to emulsify the cataractous lens the change in HRQoL is a way to grade
causes vision impairment due to the nucleus, with the fragments being sub- the impact of treatment in the patient’s
changes in opacity of the ocular lens. sequently aspirated with an ultrasound general health and functioning.
Metabolic changes occurring in the probe. The corneal incision required Although cataract extraction is the
formerly clear lens lead to a loss of for phacoemulsification probe is much most common surgical procedure,
optical clarity and blurred vision. The smaller (3 mm or less) in comparison relatively little is known about postop-
only cure for cataract is a surgical with limbal incision, usually a 11 mm erative recovery after phacoemulsifica-
procedure; the opaque lens is removed incision between cornea and sclera, tion with IOL implantation. However,
and replaced with an artificial intraoc- that has been earlier used in removal it is essential to gather knowledge of the
ular lens (IOL; Asbell et al. 2005). of the entire lens (Asbell et al. 2005). postoperative complaints associated
Cataract surgery is the most common As the surgical procedure has with surgery because these complaints
surgical procedure performed in many become less invasive, the recovery after may delay recovery after the procedure
countries including Finland (Brian & surgery is now easier and patients and may significantly influence the
Taylor 2001; Rautiainen & Rasilainen usually no longer require in-patient patient’s assessment of treatment out-
2011). Cataract is an age-related condi- hospital care after the operation. The come and quality of life (Garcıa-Cat-
tion, but some risk factors for lens modern minimally invasive cataract alan et al. 2009; Feeny et al. 2012). The
opacification have also been found. surgery with phacoemulsification is first aim of this study was to evaluate
Smoking, ocular trauma, exposure to considered as a minor procedure with the prevalence, duration and severity of
ultraviolet light, diabetes and drug- an uneventful and pain-free recovery the symptoms, and other complaints
induced metabolic changes in the lens period. However, in the published that cataract surgery patients might
are some of the conditions which have studies, little attention has been paid have after surgery. The second aim
been identified as causing cataract, in to pain and other postoperative ocular was to identify those factors that influ-
addition to hereditary and prenatal irritation symptoms, and the data on ence patient satisfaction and patient-
reasons (West & Valmadrid 1995). It the incidence of these symptoms are reported treatment outcome after cat-
has been estimated that the number of conflicting. In some studies, rather few aract surgery. The third aim was to
cataract surgeries will increase signifi- patients have reported any complaints evaluate the impact of cataract surgery
cantly in the next decades along with the after surgery (Camesasca et al. 2007; on patients’ HRQoL and compare the
rise in life expectancy (Brian & Taylor Raizman et al. 2007), whereas in other HRQoL of cataract patients to the
2001). In Finland, the median age of studies some postoperative ocular irri- similar of age- and gender-standardized
patients undergoing phacoemulsifica- tation symptoms and pain have been control population.
tion with IOL implantation is 74 years experienced by the majority and even
(Rautiainen & Rasilainen 2011). as many as 90% of patients (Stifter & 2. Review of the
In particular in the developing coun- Menapace 2007; Anders et al. 2009;
tries, cataract has formerly been a Ahmed et al. 2010; Heuermann et al.
literature
major cause of loss of vision due to 2010; Pianini et al. 2010).
2.1. Recovery after cataract surgery
the lack of appropriate surgical care. It is beneficial to conduct a patient-
According to a recent report from the defined subjective assessment when 2.1.1. Common recovery
World Health Organization focussing evaluating the vision-related improve- In most cases, recovery after modern
on the less developed regions, the ment after cataract surgery. There is a phacoemulsification cataract surgery is
major global causes of visual impair- long tradition of measuring visual acu- uncomplicated and straightforward.
ment are uncorrected refractive errors ity (VA) in ophthalmology and oph- However, as with any surgical proce-
(43%) followed by cataract (33%). In thalmic surgery, but this may not be dure, there is a possible appearance of
global terms, cataract still remains as sufficient to assess fully the visual adverse events and other complaints
the most important single cause of disabilities caused by cataract (Uusi- after surgery. Cataract surgery requires
blindness accounting for 51% of total talo et al. 1999). The measurement of corneal incision, a procedure that
cases (Pascolini & Mariotti 2012). In visual functioning (VF) and vision- induces a trauma in the corneal epithe-
the past decades, the surgical manage- related disabilities in daily life give lial cells and causes damage to the
ment of cataract has become less inva- additional information from the corneal nerves (Khanal et al. 2008;
sive. The modern surgical procedure of patient’s perspective. The measurement Rosado-Adames & Afshari 2012). The
choice is phacoemulsification with IOL of health-related quality of life surgical care of cataract includes also
implantation (Kelman 1967). The tech- (HRQoL) is another tool which can exposure to the light of the microscope

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Acta Ophthalmologica 2016

therapy. Topical anti-inflammatory


agents and antibiotics are both routinely
provided after cataract surgery. Steroi-
dal agents and non-steroidal anti-
inflammatory drugs (NSAIDs) are used
to prevent and treat the postoperative
inflammation occurring after surgery.
Antibiotics are commonly used to pre-
vent postoperative ocular infections
such as endophthalmitis (DeCroos &
Afshari 2008; Behndig et al. 2013). In
other instructions of care, patients may
also be advised to use an eye shield on
the operated eye for the first 24 hr or
even a couple of days after surgery. In
Fig. 1. Anatomy of eye. Modified from Shutterstock images, www.shutterstock.com. addition, patients should avoid hair
washing for 2 days to keep water out
Table 1. The annual numbers of phacoemulsification cataract surgeries performed in public care of the operated-on eye. The instructions
in Finland. usually advise the patient to avoid any
Year Number of surgical procedures Surgeries per one million people strenuous activity such as heavy lifting,
swimming and taking a sauna for the
1997 30 035 5835 first week after surgery (Shoss & Tsai
2000 33 317 6430 2013).
2003 39 335 7535 Corticosteroids. Steroidal anti-inflam-
2005* 41 867 7966 matory drugs, that is corticosteroids
2006 37 560 7117
inhibit the lipoxygenase pathway lead-
2007 37 902 7150
2008 41 171 7729 ing to the leukotriene production and
2009 39 300 7343 thus reduce tissue swelling and prevent
2010 43 070 8012 oedema (McMahon & Koltzenburg
2011 42 360 7842 2006; DeCroos & Afshari 2008). They
2012 38 978 7182 have been used for decades to prevent
ocular inflammation. Corticosteroids
Data are taken from somatic specialist healthcare tables, National Institute for Health and
Welfare and National Research and Development Centre for Welfare and Health. Available at:
are mainly used with antibiotics in
www.thl.fi. Population data from Population structure, Official Statistics of Finland (OSF 2013). combination therapy. Many oph-
* The Act on the Status and Rights of Patients (available at: http://www.finlex.fi/en/laki/ thalmic surgeons prefer a 1 to 6-week
kaannokset/1992/en19920785.pdf) eligible from year 2005, setting the patient’s right of availability period of topical corticosteroids after
to non-emergency treatment by legislation. cataract surgery. The possible adverse
effects of topical ocular corticosteroid
and perioperative use of ocular drugs Conjunctival hyperaemia, anterior therapy include an increase of intraoc-
that may produce ocular surface stress chamber cells and flare and cystoid ular pressure (IOP), inhibition of cor-
response and irritation (Robciuc et al. macular oedema (CME) are some pos- neal wound healing and increased
2014). In addition, topically applied sible signs of inflammation encoun- likelihood of infection and serious
ocular drugs are used in the postopera- tered after cataract surgery (DeCroos complications, but systemic adverse
tive care, and some patients experience & Afshari 2008). The severity of the effects are rare in topical use (DeCroos
symptoms and adverse effects related to inflammation varies from patient to & Afshari 2008; Gonzales et al. 2013).
the postoperative drug therapy. patient. In most cases, the inflamma- According to the practice pattern
The present review of the literature tion is self-limiting, but drug therapy is studies published by ASCRS (Ameri-
examines studies reporting results from used to hasten resolution and to can Society of Cataract Refractive
trials using the phacoemulsification increase ocular comfort after surgery Surgery 2012, practice pattern study),
technique, as phacoemulsification is (Gonzales et al. 2013). The surgical Canadian Ophthalmological Society
the most commonly used technique ocular trauma triggers the inflamma- members study 2011 (Ong-Tone et al.
and is believed to be less traumatic than tory cascade where the cleavage of 2012) and ESCRS (European Society
conventional intracapsular and extra- arachidonic acid by phospholipase-2 of Cataract Refractive Surgery 2012,
capsular cataract extraction. The surgical produces leukotrienes, prostaglandins practice pattern study), there are vari-
technique and instrumentation used may and thromboxanes, which are media- ations in postoperative drug therapy
significantly affect the extent of corneal tors of inflammation (DeCroos & provided to individual patients and
endothelium trauma during surgery Afshari 2008; Fig. 1; Table 1). between different countries. In the
(Rosado-Adames & Afshari 2012). United States and Canada, postopera-
There is some degree of postopera- 2.1.2. Postoperative care tive topical corticosteroids are used in
tive ocular inflammation which occurs In most cases, the postoperative care 92% and 89% of the surgeries, respec-
after cataract surgery in both the ante- after cataract surgery consists of anti- tively, but no corresponding data seem
rior and posterior segments of the eye. inflammatory and antibacterial drug to be available from Europe. The

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Acta Ophthalmologica 2016

duration of the topical postoperative parison with NSAIDs given by other Severe sterile or infectious inflamma-
drug therapy was 4 weeks in most cases administration routes (Stewart et al. tion of the anterior and/or posterior
(47%), 3 weeks (20%) or 2 weeks 2007). When NSAIDs are used topi- chamber of the eye, endophthalmitis, is
(15%) according to the Canadian prac- cally, the systemic adverse events such a rare yet severe condition that occurs in
tice pattern study (Ong-Tone et al. as gastrointestinal ulceration, renal 0.03–0.3% of patients undergoing cat-
2012). In Europe, dexamethasone was failure and cardiac events are rare and aract surgery (Behndig et al. 2013;
the most commonly used steroidal anti- their incidence is similar to placebo Gower et al. 2013). Endophthalmitis is
inflammatory drug chosen as the pre- (McMahon & Koltzenburg 2006). Non- a possible vision-threatening complica-
ferred drug by 71% of ophthalmolog- steroidal anti-inflammatory drugs have tion of cataract surgery. Swollen eyelids,
ical surgeons, followed by prednisolone been reported to decrease the incidence ocular pain, conjunctival hyperaemia,
(19% of surgeons) and betamethasone of postoperative CME and also to decreased VA, anterior chamber cells
with the proportion of 7%. In Finland, improve the postoperative VA after and an opaque vitreous are signs of
the topical antibiotic-corticosteroid cataract surgery (Gonzales et al. 2013). endophthalmitis. This condition usually
therapy lasting for approximately In America and Canada, topical appears during the first days after
1 month is recommended (Cataract: NSAIDs are provided to 71% and surgery, and in 80% of cases, the
Current Care Guidelines 2014). 74% of patients undergoing cataract endophthalmitis will have developed
Antibiotics. Topically applied antibi- surgery, respectively (ASCRS 2012, during the first 6 weeks after surgery
otics are routinely used for the prophy- practice pattern study; Ong-Tone et al. (Barry et al. 2009; Gower et al. 2013).
laxis of postoperative bacterial ocular 2012). The proportion of European Cystoid macular oedema is the most
infections such as endophthalmitis. ophthalmic surgeons using postopera- common cause of poor visual outcome
Intraocular, usually intracameral or tive NSAIDs in the postoperative care following cataract surgery. The exact
subconjunctival, antibiotics are used after cataract surgery was not stated in cause of the condition is unclear, but
during the surgery, and both pre- and/ the European ESCRS report, but the surgical complications and postopera-
or postoperative topical applications are most commonly preferred NSAIDs tive inflammatory processes have been
also provided (Behndig et al. 2013). were diclofenac (36%), nepafenac proposed being the causative factors.
Cefuroxime is the most widely used (24%) and bromfenac (13%). A total Patients with diabetes mellitus carry a
drug in perioperative intraocular injec- 77% of the surgeons in the ASCRS higher risk for postoperative CME.
tions in Europe (Gower et al. 2013). study, 61% in the Canadian study and The dilated capillaries cause leakage
When one considers postoperative 38% in the ESCRS study preferred and accumulation of intraretinal fluid
topical antibiotic agents, then it seems starting the NSAID therapy before the in the central retina, macula. The
that in North America the fourth- operation day. incidence of clinically significant CME
generation fluoroquinolones were the after modern cataract surgery is esti-
most extensively prescribed antibiotics 2.1.3. Possible complaints mated to be between 0.1% and 3.3%
being chosen by 93% of the American Cataract surgery carries a risk of <2% (Dieleman et al. 2011; Greenberg et al.
respondents and by 87% of the Cana- for serious or vision-threatening com- 2011; Zur et al. 2011). In contrast, the
dians, respectively (ACRS 2012, prac- plications such as severe inflammation, incidence of a clinically not important
tice pattern study, Ong-Tone et al. retinal detachment or suprachoroidal CME, which nonetheless can be
2012). The most widely used drugs in haemorrhage, and is, thus, considered detected on optical coherence tomog-
Europe were tobramycin (25%), mox- as a low-risk procedure (Shoss & Tsai raphy, is reported to be as high as 25%
ifloxacin (17%) and chloramphenicol 2013; de Silva et al. 2014). However, and greater than the condition causing
(17%) according to the ESCRS (2012) some less severe complications and poor visual outcome (Dieleman et al.
study report. complaints have been reported to occur 2011). The peak incidence of CME
Non-steroidal anti-inflammatory agents. more commonly after uncomplicated occurs between 4 and 6 weeks after
The non-steroidal anti-inflammatory cataract surgery. surgery; if the duration of CME is
drugs act by blocking the synthesis of Cataract surgery can cause ocular <4 months, it often resolves sponta-
prostanoids, which are produced from dryness, and it may make worse previ- neously. Cystoid macular oedema per-
arachidonic acid in response to tissue ously present dry eye symptoms (Stifter sisting for 4 months or more is termed
damage and inflammation. Non-ster- & Menapace 2007; Kasetsuwan et al. chronic CME. Steroidal and non-ster-
oidal anti-inflammatory drugs differ in 2013). The symptoms of postoperative oidal anti-inflammatory agents are
both potency and elimination time ocular dryness have been reported to used in the treatment of CME with
(McMahon et al. 2006). When dis- occur immediately after surgery in some topical and/or systemic applications
pensed as eye drops, NSAID are gen- patients (Li et al. 2007, Stifter & Mena- (Sivaprasad et al. 2012; Shoss & Tsai
erally safe as only small doses of pace 2007, Sipos et al. 2011, Kaset- 2013). Recently, an intravitreal implant
NSAIDs are used in topical adminis- suwan et al. 2013). Symptoms and of dexamethasone has been developed
tration. The possible local adverse postoperative changes in tear film for the treatment of macular oedema
effects of topical NSAID therapy parameters were present at 2 months (Haller et al. 2010; Querques et al.
include post-cataract surgery atonic after surgery in the studies of Li et al. 2014). In addition, in recent years,
mydriasis, contact dermatitis, delayed (2007) and Cho & Kim (2009). In a study intravitreal anti-angiogenic drug ther-
wound healing, slowed corneal re- published by Venincasa et al. (2013), no apy with vascular endothelial growth
epithelialization and corneal melting difference in tear film parameters was factor (VEGF) inhibitors has been used
(Guidera et al. 2001; Flach 2002). The detected between the operated and unop- in the treatment of CME (Pielen et al.
systemic exposure is much less in com- erated eye at 3 months after surgery. 2013).

4
Acta Ophthalmologica 2016

An elevation in IOP of more than rior capsular cells may undergo hyper- symptoms (McMahon & Koltzenburg
30 mmHg immediately or during the plasia and cellular migration, 2006).
first days after cataract surgery has appearing as a thickening, opacifica- According to the definition devised
been reported in 0.1–14% of patients in tion and clouding of the posterior lens by the International Association for
the examined studies (Lane et al. 2007; capsule, posterior capsule opacifica- the Study of Pain (IASP 2011, Classi-
Mohammadpour et al. 2007; Shingle- tion. Posterior capsule opacification is fication of Chronic Pain; Bonica 1979),
ton et al. 2007; Pianini et al. 2010; the most commonly reported late com- pain is ‘an unpleasant sensory and
Smith et al. 2010; Dell et al. 2011; plication of phacoemulsification catar- emotional experience associated with
Dieleman et al. 2011; Donnenfeld et al. act surgery, and the reported incidence actual or potential tissue damage, or
2011; Fan et al. 2014). Patients with a seems to vary between 2% and over described in terms of such damage’.
history of glaucoma surgery, high 50% (Asbell et al. 2005). Posterior According to this definition, pain is a
myopia and diabetes mellitus carry a capsule opacification that compromises subjective, unpleasant sensorial and
higher risk for early IOP elevation after vision can be treated with capsulotomy emotional experience. As a third com-
surgery. The IOP elevation is also a performed with a yttrium aluminium ponent, pain has a cognitive dimension,
possible adverse effect of topical corti- garnet (YAG) laser (Fig. 2). that is patients confer meanings on the
costeroid therapy (Mohammadpour postoperative complaints that they
et al. 2007; Fan et al. 2014). In some experience (Bonica 1979; IASP 2011
2.2. Ocular symptoms after cataract
patients with preoperatively existing Classification of Chronic Pain). Ocular
surgery
primary open-angle glaucoma and ocu- irritation symptoms such as itchiness,
lar hypertension, there may be also a 2.2.1. Pain and other ocular symptoms stinging, burning and foreign body
modest and long-lasting decrease in The cornea is one of the most densely sensation are common after oph-
IOP occurring after cataract surgery innervated tissues in the human body thalmic surgery, and it can be difficult
(Hayashi et al. 2001; Shingleton et al. and thus highly pain-sensitive (M€ uller to distinguish these symptoms from
2007; Shrivastava & Singh 2010). et al. 2003). Cataract surgery causes postoperative pain (Hovanesian et al.
There are also some more rare corneal endothelium trauma, ocular 2001; Li et al. 2007; Fong et al. 2012).
major complications such as an incor- inflammation and ocular dryness that Moreover, the elderly may use euphe-
rect position of the IOL, retained lens can result in ocular irritation during the misms in reporting pain conditions that
fragments after complicated surgery, recovery period (Li et al. 2007; make pain assessment a challenging
toxic anterior chamber inflammation, Rosado-Adames & Afshari 2012; task (Closs & Briggs 2002).
leakage of the wound, bullous ker- Kasetsuwan et al. 2013). These condi- In most of the reviewed randomized
atopathy, suprachoroidal haemorrhage tions may cause different types of ocu- placebo-controlled trials evaluating the
and retinal detachment which may lar discomfort symptoms such as pain, use of topical ocular anti-inflammatory
also be detected during the early burning, stinging, foreign body sensa- agents or antibiotics during the first days
recovery (Tilleul et al. 2010; Taravati tion, itchiness and glare in the operated and weeks after cataract surgery, the
et al. 2012; Shoss & Tsai 2013). The eye. Ocular irritation symptoms are postoperative ocular irritation symp-
underlying condition of uveitis may often considered also as symptoms of toms have been reported as part of the
also be exacerbated after cataract ocular dryness and ocular surface dis- safety and tolerability analysis of the
surgery (Mohammadpour et al. 2007). ease, or symptoms of superficial ocular study drug. The ocular irritation symp-
The intraoperative complications that pain (McMahon & Koltzenburg 2006; toms were considered as possible drug-
may lead to combined surgeries Dry Eye WorksShop 2007). related adverse events, and the routinely
increase also the risk for other post- Severe postoperative ocular pain is used topical ocular drugs cause transient
operative complications, as in the case assumed to be a sign of postoperative discomfort in conjunction with drop
of posterior capsule rupture or vitre- elevation of intraocular pressure, instillation in some patients. Drop-
ous prolapse during the cataract sur- inflammation or infection, all condi- related discomfort sensations such as
gery (Jakobsson et al. 2009; Ti et al. tions requiring immediate care. This stinging and burning have been reported
2014). type of intense ocular pain can be also by 15–40% of patients in studies that
As a reaction to cataract surgery classified as deep ocular pain, distin- used topical NSAIDs, corticosteroids or
occurring in some patients, the poste- guishing it from superficial ocular pain corticosteroid-antibiotic combinations

Fig. 2. Cataract surgery using the phacoemulsification technique. Modified from: www.vision-and-eye-health.com.

5
Acta Ophthalmologica 2016

(Sandoval et al. 2006; Pianini et al. ate or severe pain was 71–85% at 2 hr symptoms at 1 hr after surgery, but no
2010; Fong et al. 2012; Rajpal et al. after surgery, and at 6 hr after surgery, longer at 6 or 24 hr after surgery.
2013). In most studies, the ocular symp- 30–36% of the patients still reported
toms were more common in patients significant pain in both groups. 2.2.3. Symptoms during the first days
treated with placebo and less common in In most studies evaluating the sever- after surgery
the study groups of different NSAIDs ity of postoperative pain after cataract 2.2.3.1. Pain. During the last decade,
(Price & Price 2004; Maxwell et al. 2008; surgery, the severity was mild. In the incidence of postoperative pain
Donnenfeld et al. 2011; Silverstein et al. most studies, pain was assessed using during the first 72 postoperative hours
2011; Fong et al. 2012; Rajpal et al. a Visual Analogue Scale (VAS) or a has been evaluated in several random-
2013; Walters et al. 2014). Although Numerical Rating Scale (NRS) with a ized controlled studies. After discharge,
topical ophthalmic solutions of vehicle range from 0 = no pain to 10 = most circa half of the patients have reported
do not include any medication, in most pain. The mean pain scores during the postoperative pain in the placebo-
cases the formulation contains the same first hours after surgery varied between treated control groups (Lane et al.
preservatives as present in the study 0.5 and 1.7/10 (Kongsap et al. 2006; 2007; Nardi et al. 2007; Maxwell et al.
drug. Consequently, these compounds Stifter & Menapace 2007; Dell et al. 2008; Donnenfeld et al. 2011; Fong
may cause preservative-induced ocular 2011; Kaluzny et al. 2010). Although et al. 2012; Rajpal et al. 2013; Walters
irritation in the vehicle-treated patients, the mean pain severity was mild, some et al. 2014). In the active intervention
in addition to failing to provide any patients did experience significant post- groups, pain was generally less fre-
symptom-reducing anti-inflammatory operative pain. quent; 3–52% of patients in these
effects. The most commonly used In the Stifter & Menapace (2007) groups experienced postoperative pain
preservative is benzalkonium chloride study those patients wearing a postop- after discharge (Bainbridge et al. 1998;
(BAK; Cho & Kim 2009), but the other erative eye patch were compared to Camesasca et al. 2007; Lane et al.
preservatives also have cytotoxic and unpatched patients after bilateral cat- 2007; Nardi et al. 2007; Raizman et al.
inflammatory effects (Paimela et al. aract surgery. One out of every eight 2007; Maxwell et al. 2008; Baiza-
2012). Typical adverse effects of eye patients (12%) in the unpatched group Duran et al. 2009; Dell et al. 2011;
drops containing BAK include superfi- reported moderate to severe postoper- Donnenfeld et al. 2011; Silverstein
cial punctuate keratopathy, epithelial ative pain. In that study, a negative et al. 2011; Fong et al. 2012; Walters
erosions, conjunctival hyperaemia, tear- correlation (r = 0.75 to 0.91) was et al. 2014). By contrast, in the Mohan
ing and subjective painful sensations noted between tear film break-up time et al. (2001) study, 53–90% of the
such as foreign body sensations, itchi- (BUT) and ocular pain score during the patients reported pain. However, most
ness, burning, stinging and ocular irri- first hours after surgery. No moderate patients in the latter study reported
tation (Pisella et al. 2002; Jaenen et al. or severe pain was reported in the only slight pain. A total 26% of
2007; Uusitalo et al. 2008, 2010). patched eye group. Another study patients in the intervention group,
detected pain in 55–82% of patients treated with ciprofloxacin–dexametha-
2.2.2. Symptoms during the first hours with either artificial tears or ocular sone ophthalmic suspension, experi-
after surgery bandage at 1 hr after surgery. The enced significant pain, versus none in
2.2.2.1. Pain. Several randomized prevalence of pain decreased to 0– the active control group treated with an
controlled studies report the incidence 11% during the first 24 hr after surgery ophthalmic suspension of betametha-
or severity of pain during the first (Sipos et al. 2011). Recently, the effect sone–neomycin (Mohan et al. 2001). In
postoperative hours after cataract sur- of a subconjunctival injection of corti- a study that combined two randomized
gery. However, the reported incidences costeroid-antibiotic solution was com- phase three trials, 51% of patients in
of early-onset postoperative ocular pared with iodine eye drops (Ahmed the placebo group reported pain during
pain vary significantly in the published et al. 2010). Postoperative pain was the first postoperative day, versus 21%
literature. significantly higher in patients treated in the group treated with bromfenac
During the first postoperative hours, with subconjunctival injection of dex- 0.07% ophthalmic solution. At 3 days
pain was reported by 6–95% of patients amethasone–gentamycin, 5.7/10, as after surgery, the prevalence of pain in
in studies by Price & Price (2004), compared to patients receiving iodine the two groups was 47% and 14%,
Kongsap & Wiriyaluppa (2006), Russo eye drops, 2.7/10. respectively (Walters et al. 2014).
et al. (2007), Anders et al. (2009), 2.2.2.2. Other symptoms. Other ocular There are studies that have evalu-
Heuermann et al. (2010), Kaluzny et al. irritation symptoms are commonly ated the efficacy of anti-inflammatory
(2010) and Dell et al. (2011). The inci- reported during the first hours after agents in patients with postoperative
dence of moderate or severe pain ranged cataract surgery. The incidence of ocu- inflammation. In these reports, more
from 1% up to 35% in the reports lar irritation symptoms experienced pain has been reported in comparison
published by Stifter & Menapace (2007), during the first postoperative hours with studies with less selected patient
Kaluzny et al. (2010) and Dell et al. may be as high as 98% according to groups. In a recent multicentre study, a
(2011). In the studies conducted by the study of Dell et al. (2011). There is a total of 407 patients with an anterior
Anders et al. (1999) and Heuermann report that minimal or mild photopho- chamber cell count of more than 6
et al. (2010), the patients received an bia is present in 75–100% of patients (grade ≥1) in the operated eye were
intraoperative intracameral injection of immediately after surgery (Pang et al. randomized to receive either lotepred-
lidocaine in the intervention group and a 2001). Sipos et al. (2011) showed that nol etabonate 0.5% gel or vehicle after
peribulbar injection of prilocaine in the artificial tear therapy reduced signifi- cataract surgery. At 18–34 hr postop-
control group. The incidence of moder- cantly early painful ocular irritation eratively, ocular pain was experienced

6
Acta Ophthalmologica 2016

by 50% of patients in both groups, and The resolution of early-onset post- mon et al. 2001; Lane et al. 2007). The
45% of patients required rescue med- operative pain occurs during the first severity of the reported symptoms is
ication (NSAIDs or corticosteroids) days and weeks after surgery as the generally mild and <4/10 on the VAS
during the study period which lasted prevalence of pain generally decreases (Solomon et al. 2001; Donnenfeld
until 18 days after surgery (Fong et al. along with the course of the recovery. et al. 2006; Russo et al. 2007).
2012). In a study on patients with In three recent studies, the median time Bright visual artefact defects such as
anterior chamber cells of grade 2, to resolution of pain was 1–4 days glare, halos and starburst symptoms,
58% of placebo-treated patients and (Dell et al. 2011; Donnenfeld et al. that is positive dysphotopsia, are com-
27% of patients receiving loteprednol 2011; Silverstein et al. 2011). mon after cataract surgery and may
etabonate still reported pain at 8 days The severity of pain during the first occur in as many as every second
after surgery (Rajpal et al. 2013). weeks after surgery is reported to be patient. Positive dysphotopsia is con-
2.2.3.2. Other symptoms. In most of mild in general. After discharge and up sidered as a lens-related deficit phe-
the study reports, the presence of to 4 weeks after surgery, the mean pain nomenon, whereas the aetiology of
ocular irritation symptoms such as score assessed with VAS or NRS has negative dysphotopsia, the presence
foreign body sensation, itching, sting- ranged between 0.6 and 2.5/10 (Ahmed shadows and dark spots in the visual
ing, burning and photophobia are et al. 2010; Dieleman et al. 2011). In field, remains unknown (Schwiegerling
reported as part of the safety analysis studies where postoperative pain after 2006; Visser et al. 2011).
of the study drug. Ocular irritation cataract surgery has been measured with
symptoms were reported by 40–70% of a verbal rating scale (VRS), most
2.3. Outcome and satisfaction after
patients during the first day after patients have reported either no pain
surgery
surgery in the publication of Sandoval or only mild pain (Paganelli et al. 2004;
et al. (2006), by 45–56% of patients in Donnenfeld et al. 2006; Camesasca 2.3.1. Measuring vision-related outcome
that of Bainbridge et al. (1998) and by et al. 2007, Duong et al. 2007; Raizman The significant improvement of VA
13–55% in the work of Silverstein et al. et al. 2007). and VF after cataract surgery has been
(2011). In contrast, in some studies One study has described more severe documented well in numerous study
ocular irritation symptoms have been pain in comparison with other studies, assessments, and the benefits of catar-
reported by fewer than 5% of patients and this being experienced at 7 days act surgery as a highly effective surgery
(Maxwell et al. 2008; Donnenfeld et al. after surgery. One-third (33%) of with minimal complications are beyond
2011). Dry eye symptoms were patients who received preservative-free doubt. Measurement of VA has long
reported by 16–32% of patients in the dexamethasone–netilmicin eye drops, traditions in ophthalmology in the
Camesasca et al. (2007) study. Ocular and 45% of patients who received assessment of visual ability. Although
photophobia and tearing were reported preservative-containing dexametha- the vision-related ability to perform
at 18–34 hr after surgery by 57% and sone–tobramycin eye drops, reported everyday tasks is the most important
42% of patients in Fong et al. (2012) moderate or severe pain (Pianini et al. outcome for the patient, VA is one of
and continual tearing by 53–65% in 2010). Similarly, in the work of Walters the most important clinical outcomes
Mohan et al. (2001). et al. (2014), at 15 days after surgery, a for the cataract surgeon.
third of patients in the placebo group Measurement of VA was developed
2.2.4. Symptoms during the first weeks and 8% of patients treated with brom- at the 1840–1850s to standardize vision
after surgery fenac 0.07% ophthalmic suspension tests (Tasman & Jaeger 1992). However,
2.2.4.1. Pain. The prevalence of ocu- reported pain. the use of VA alone neither assesses the
lar pain declines during the first weeks 2.2.4.2. Other symptoms. In the litera- full impact of cataract nor estimates the
after surgery and is at its most intense ture, there are substantial variations in full benefit of cataract surgery to the
during the first days after surgery. In the reported prevalence of ocular irri- patient (McAlinden et al. 2011). A
the studies evaluating the postoperative tation symptoms during the first weeks number of cataract surgery outcome
pain during the first few days after after surgery. Ocular irritation symp- questionnaires have been developed
cataract surgery, the prevalence of pain toms were described by 27%–84% of attempting to estimate the difficulty that
varies in the intervention groups patients treated with a topical NSAID, people experience when performing
between 2% and 26%, whereas in the a corticosteroid or placebo (Smith daily activities. This trait is known as
placebo groups it is higher, ranging et al. 2010; Silverstein et al. 2011). VF, visual disability or vision-related
between 29% and up to 58% (Mohan The duration of the symptoms may activity limitation (McAlinden et al.
et al. 2001; Lane et al. 2007; Nardi last several weeks in some patients; 29– 2011). When evaluating the outcome
et al. 2007; Maxwell et al. 2008; Baiza- 50% of patients reported ocular dis- after cataract surgery, many previous
Duran et al. 2009; Dell et al. 2011; comfort at 28–30 days after surgery in studies have preferred to measure VF
Silverstein et al. 2011; Fong et al. 2012; two studies (Smith et al. 2010; Dell instead of VA (Steinberg et al. 1994a,b;
Rajpal et al. 2013; Modi et al. 2014; et al. 2011). Photophobia was experi- Cassard et al. 1995; Uusitalo & Tarkka-
Walters et al. 2014). Raizman et al. enced by 40–65% of patients and nen 1998; Uusitalo et al. 1999; Fried-
(2007) reported less pain compared to tearing by 16–35% of patients at 3– man et al. 2002; Mamidipudi et al.
other studies in a study comparing two 15 days after surgery in the Comstock 2003; Rosen et al. 2005; McAlinden
topical prednisolone formulas. In that et al. (2011) study. Less frequent symp- et al. 2011).
study, pain was reported only by 3–6% toms were reported in some studies, There are multiple questionnaires
of patients during the first weeks after with <10% of patients reporting some available which have been developed to
surgery. symptoms of ocular irritation (Solo- measure VF. The Catquest questionnaire

7
Acta Ophthalmologica 2016

was developed in Sweden and initially 1 month after cataract surgery were et al. 2005; Nord et al. 2009; Wisløff
consisted of 17 items (Lundstr€om et al. significantly older and were also dis- et al. 2014).
1997). This questionnaire was short- satisfied with their medical care and life
ened to a 9-item short form version in general. In that study, those patients 2.4.2. Generic instruments of health-
Catquest-9SF, and this is considered as tended to claim that they felt no related quality of life
the most responsive VF questionnaire functional improvement even though Several generic instruments of HRQoL
in a study which compared 16 ques- there was an improvement in their have been developed. A 5-domain
tionnaires (Lundstr€ om & Pesudovs VA. instrument, the EQ-5D, is used widely,
2009; McAlinden et al. 2011). Visual In two studies, the presence of ocu- and in combination with a VAS, it
functioning index (VF) questionnaires lar complications after cataract extrac- forms the EuroQol questionnaire
are popular, and they too have been tion has been related to less satisfaction (EuroQol Group 1990). The Sickness
abridged from the original 14-item with the outcome (Schein et al. 1995; Impact Profile (SIP) consists of physi-
version VF-14 (Steinberg et al. 1994a, Garcia-Gutierrez et al. 2014). In the cal, psychosocial and five other dimen-
b). The Cataract Symptoms Score, study of Kinard et al. (2013), the pres- sions concerning daily activities. The
CSS, has been revised from initial 14- ence of pseudophakic dysphotopsia original 136-item version has been
item questionnaire and consists of two was associated with postoperative dis- shortened to a 68-item questionnaire
subscales, mobility and VF (Gothwal satisfaction. (de Bruin et al. 1994). Both the SF-36
et al. 2009). The National Eye Institute and SF-12 questionnaires include eight
Visual Function Questionnaires (NEI- health domains: physical functioning,
2.4. Cataract surgery and health-related
VFQ) were originally 51-, 39- and 25- role physical, bodily pain, general
quality of life
item questionnaires, but these also now health, vitality, social functioning, role
have many abbreviated versions (Man- 2.4.1. Measuring health-related quality emotional and mental health
gione et al. 1998). There are several of life (Hawthorne et al. 2007). The SF-6D
other questionnaires being also used by Disease-specific instruments are widely is a shortened version of these ques-
ophthalmologists. used to measure the vision-related qual- tionnaires (Brazier et al. 2002). The
ity of life (McAlinden et al. 2011). These Nottingham Health Profile (NHP) was
2.3.2. Satisfaction with treatment out- instruments, however, do not allow any developed in the 1970s and consists of
come comparison in between ophthalmologi- two parts, one addressing the health
In addition to measurement of VA and cal procedures and other interventions status with the other estimating the
VF, it has been proposed that a change from other medical specialities in terms impact of health on daily living (Hunt
in patient satisfaction after cataract of HRQoL or cost-effectiveness. The et al. 1981). The Health Utility Index
surgery could be used as a quantitative generic HRQoL instruments include instruments have two systems, HUI2
reference measure for other outcomes both profile and single index score and HUI3. The initial HUI1 was
(Uusitalo et al. 1999). Many previous instruments. The measurement of developed to be used in evaluating the
studies have described a apparent cor- HRQoL with the latter produces an outcomes of very low-birthweight
relation between visual functioning and utility index score, usually between 0 infants (Horsman et al. 2003). The
patient satisfaction after cataract sur- (equivalent to being death) and 1 (equiv- Quality of Well-Being Scale–Self-
gery (Steinberg et al. 1994a,b; Lund- alent to full, symptom-free functioning). Administered version (QWB-SA) con-
str€
om et al. 1997; Uusitalo & The EuroQol Group Association five sists of five parts and 74 items including
Tarkkanen 1998; Uusitalo et al. 1999; domain questionnaire (EQ-5D), the a symptom checklist and function sec-
Friedman et al. 2002; Mamidipudi Short Form Health Survey (SF-6D), tions (Andresen et al. 1998).
et al. 2003; Lundstr€
om & Stenevi 2013). the Health Utility Index instruments The 15D is an 15-item instrument
The reasons for dissatisfaction in (HUI) and the 15-dimensional health developed in Finland that can be used
some of those patients experiencing state descriptive questionnaire 15D are both as a profile instrument and a
good clinical and functional outcome examples of single index score instru- single index utility score measure. As
are not fully understood. In a recent ments (R€ as€
anen et al. 2006b). a profile instrument, the result reflects
study of 4335 patients, the patient The index score is necessary if one the health status of an individual or
factors that were found to correlate wishes to conduct a cost-utility analysis patient group in all of the different
with better postoperative satisfaction using Quality-Adjusted Life Years dimensions, and a value component is
were good preoperative physical and (QALY) gained as a measure of the needed to aggregate the measurements
mental health and higher education effectiveness of care (Fanshel & Bush on the dimensions into a single index
(Garcia-Gutierrez et al. 2014). The 1970; Torrance et al. 1972; Weinstein & score (Sintonen 1995, 2001). The 15D
ocular complaints and symptoms asso- Stason 1977; Gold et al. 1996; Wein- instrument has 15 dimensions; mov-
ciated with surgery may delay recovery stein et al. 2009). The HRQoL and ing, seeing, hearing, breathing, sleep-
after the procedure and may also QALY analysis allows comparison of ing, eating, speech, excretion, usual
influence the patient’s assessment of the value of the treatment of different activities, mental function, discomfort
the overall treatment outcome and diseases from the patient perspective. and symptoms, depression, distress,
quality of life (Garcıa-Catalan et al. Accordingly, it is possible to estimate vitality and sexual activity. All these
2009; Feeny et al. 2012). Chang-God- and compare the patient-assessed sub- produce an individual value between 1
inich et al. (1999) reported that those jective effects of different procedures on and 5 that is converted to a single
patients who were dissatisfied with quality of life by analysing the changes index number of 0 to 1 (15D-score)
postoperative visual improvement of HRQoL (Gold et al. 1996; Ramsey with a valuation system based on the

8
Acta Ophthalmologica 2016

multi-attribute utility theory (Sinto- 3. Aims of the study tion was introduced in the treatment
nen 1995). of cataract in 1967 and gained accep-
The general aim of the study was to tance in the early 1990s when safety
2.4.3. Health-related quality of life after evaluate the recovery up to 12 months and efficacy had improved (Emery
cataract surgery after phacoemulsification cataract sur- et al. 1978). The efficacy of the pha-
Cataract surgery is considered as one gery with IOL implantation. coemulsification technique and the
of the most cost-effective surgical pro- The specific aims were as follows: increase in life expectancy are the
cedures (Busbee et al. 2002; Riaz et al. I To review the current literature on reasons for the rising number of pro-
2006). However, some previous multi- postoperative pain after cataract cedures performed. As the number of
attribute utility analyses using generic surgery (Publication I). elderly people increases, the need for
instruments of the HRQoL have II To evaluate early (Publication II) procedures will rise because cataract is
yielded inconsistent results with catar- and late recovery (Publication III) an age-related condition and surgery is
act patients. Steinberg et al. (1994a,b) after cataract surgery. the only effective treatment for the loss
stated that 67% of patients experi- III To evaluate patient satisfaction with of lens transparency. In Finland, the
enced significant improvement in the the treatment outcome and to iden- median age of patients having pha-
SIP at 4 months after cataract surgery, tify the factors that may contribute coemulsification with intraocular lens
even though the VA had improved in to dissatisfaction with the cataract (IOL) implantation is 74 years (Rauti-
almost all (96%) and VF-14 in 89% of surgery procedure (Publication III). ainen & Rasilainen 2011).
patients. Rosen et al. (2005) reported a IV To assess the effect of cataract Although cataract extraction is that
significant improvement in both the surgery on HRQoL (Publication IV). common, little is known about postop-
generic instrument QWB-SA and dis- erative recovery and pain
ease-specific VF-14-instrument after after phacoemulsification with IOL
cataract surgery. However, in patients 4. Publication I. implantation. However, knowledge of
with preoperative VA better than 20 of Postoperative pain after the postoperative complaints associated
40 in the operated eye or 20 of 50 in with ophthalmic surgery is necessary
the unoperated eye, there was no cataract surgery because these complaints may delay
significant improvement in QWB-SA. recovery and may significantly influence
R€as€anen et al. (2006a,b) reported an Abstract quality of life after the procedure. Pain
insignificant improvement in the over- Cataract extraction surgery is the most after ophthalmic surgery is often con-
all utility score with the 15D instru- common surgical procedure, but sidered to be a sign of a possible com-
ment, as none of the other dimensions knowledge of postoperative pain plication. Severe pain is assumed to be a
improved significantly despite the related to cataract surgery is sparse. sign of postoperative inflammation or
improvement in vision. In this systematic review, the incidence, infection, making it a concern for both
Brown et al. (2013) detected a 21% prevalence and management of pain the patient and the physician (V€ alim€
aki
gain in quality of life after first-eye after phacoemulsification surgery were et al. 2012). However, a surgery without
cataract surgery compared to an identified using PubMed and Scopus. any perioperative complications may
untreated cohort, and 1.6 QALYs gain Selected studies were restricted to also be associated with significant post-
in utility after cataract surgery. Busbee randomized controlled trials with inter- operative pain during the early recovery.
et al. (2002) used the same methodol- ventions on postoperative inflamma- Thus, appropriate counselling and pain
ogy, calculating the utility score from tion and pain. Data from 105 articles management should be provided to
VA; the improvement was rather sim- were extracted, and 21 studies met the improve quality of life.
ilar, 1.5 QALYs to that reported by final inclusion criteria. Most studies To understand current knowledge
Brown et al. (2013). The EQ-5D-ques- reported no or only mild postoperative about recovery after cataract surgery
tionnaire and VAS were used by Dan- pain, but some studies reported mod- and the complaints that patients may
quah et al. (2014); they observed a erate and severe pain and pain lasting have after discharge, we performed a
significant improvement in many several weeks. The interventions con- systematic review of the literature. Our
dimensions of the EQ-5D at 1 year sisted of drug therapy including topical aims were (1) to evaluate the incidence
after surgery. At baseline, the scores of non-steroidal anti-inflammatory drugs, and amount of postoperative oph-
cataract patients were significantly corticosteroids, paracetamol, perioper- thalmic pain and (2) to identify meth-
worse than those of control patients ative intraocular injections, eye pads ods of pain management used after
with no vision difficulties, but after used after surgery and different surgical cataract extraction surgery.
surgery there were no statistically sig- techniques. The reviewed literature
nificant differences between the groups. indicates that cataract surgery is asso- 4.2. Methods
The recent review of Agarwal & ciated with significant postoperative
Kumar (2011) highlighted the varia- pain in some patients that should be 4.2.1. Search strategy
tions in the values of cost-utility. The provided with appropriate counselling A systematic search for relevant studies
cost per QALYs gained of cataract and pain treatment. was performed according to the
surgery for first eye has varied between Cochrane Handbook for Systematic
245 and 22 000 USD/QALY in Wes- Reviews of Interventions (Higgins &
4.1. Introduction
tern countries and between 9 and 1600 Green 2011) in the PubMed database,
USD/QALY in the developing coun- Cataract surgery is the most common including the MEDLINE and Scopus
tries. surgical procedure. Phacoemulsifica- databases. The search was performed

9
Acta Ophthalmologica 2016

PUBM ED: 825 citations SCOPUS: 869 citations


Total: 1694 citations
Excluded: 1345 citations

Studies not related to ophthalmology


349 citations: Animal studies and basic research studies
Reviewed by two authors
using titles and abstracts
Excluded: 244 citations

Studies with other ophthalmological interventions than


cataract extraction
Trials of interventions only on anaesthesia strategies and
studies discussing only perioperative conditions
105 citations:
Included in the full-text analysis
made by two authors Excluded: 83 citations
Did not concern postoperative pain: 15
Included only patients with an adverse event or
complication: 12
Surgeries performed were not limited to cataract
extractions: 4
Surgical techique used was other than phacoemulsification
or not described: 9
Could not be reached via KUH/UEF information service:8
Language used other than English, Germany, Spanish, or
French: 3
Was not original article:17
Prospective or retrospective survey, a cohort or case series,
letter to the editor or a commentary: 15
Only RCTs included in the final analysis:
21 trials, 22 reports

Fig. 3. Flow diagram of the included and excluded articles. RCT = Randomized controlled trial, KUH = Kuopio University Hospital,
UEF = University of Eastern Finland.

in July 2011. The following search on the basis of their titles by two of the randomized controlled trials (RCTs)
terms were used: cataract extraction* authors. Then, the abstracts of the were included in the final analysis. The
AND pain, cataract* AND pain, cat- available articles were examined. Our number of eligible RCTs was 21 [22
aract* AND pain, postoperative. searches yielded 825 study reports publications; the results of one study
Search filters and language restrictions from the PubMed database and 869 were reported in two papers: Anders
were not used in the initial search. reports from the Scopus database. et al. (1999) and Heuermann et al.
Articles with no ophthalmological (2000)]. The other reports were
4.2.2. Selection criteria, types of studies intervention were excluded by one excluded for the following reasons:
Randomized controlled trials with author (SP-T). The remaining 349 the study did not concern intraopera-
active- or placebo-controlled treat- titles and abstracts were then evalu- tive or postoperative pain (n = 9); the
ment groups were included. Both ated by two authors (SP-T and HK). study discussed only intraoperative and
blinded and open-label studies were Reports that did not address postop- no postoperative pain (n = 6); the
eligible for the review. The language erative intervention, such as those study included only patients with
of publication of eligible studies was discussing only perioperative condi- endophthalmitis, other postoperative
restricted to English, German, French tions and anaesthesia, were excluded. inflammation or other complications
or Spanish. Finally, 105 reports were considered (n = 12); the surgical technique used
eligible by both authors and were was not phacoemulsification (n = 6);
4.2.3. Types of participants retrieved for data extraction. At this the surgical technique was not
Included studies were limited to adult stage, all remaining studies were described (n = 3); the study was not
patients with senile/presenile cataract included in the review. limited to cataract extractions; that is,
who had cataract extraction surgery. various ophthalmic surgeries were
Studies presenting data only on paedi- 4.2.6. Data extraction and analysis included (n = 4); the study report could
atric patients or animals were excluded. Data from 104 studies were extracted not be obtained from the hospital/
from the 105 original papers using a university information service (n = 8);
4.2.4. Types of interventions standardized form. The following data the study report was published only in
We included data from studies using were collected: (1) study design and a language other than English, Ger-
the phacoemulsification technique for number of participants, (2) study drugs man, Spanish or French (n = 3); the
cataract extraction. Studies using all or other study intervention evaluated, study was not an original article
analgesics, antiinflammatory agents (3) pain assessment methods and (n = 17); the study design was a
and other postoperative interventions instruments and schedule of pain prospective or retrospective survey, or
were considered eligible. assessment and (4) the primary out- a cohort or case series, and not a RCT
come parameter concerning postoper- (n = 11); or the article was a letter to
4.2.5. Selection of studies ative pain. the editor or a commentary (n = 4).
The articles to be included in this All 105 original reports were read to Figure 3 summarizes the article selec-
review were first selected individually assess eligibility. At this stage, only tion process.

10
Table 2. Randomized studies included in the analysis.

Study* Study design and participants Study intervention Pain measurement Main results concerning postoperative pain Quality†

Anders (1999) Open study Infiltration + intraocular VRS 0–1 No pain: 5% versus 15% 3
n = 200 lidocaine versus peribulbar POH: 2, 4, 6 Severe pain: 30–85% versus 28–73%
lidocaine Intraocular more pain POH 2, p = 0.0017
Heuermann (2000) Open study Infiltration + intraocular VRS 0–4 No pain: 5% versus 15% 3
n = 186 lidocaine versus peribulbar POH: 2, 4, 6 Severe pain: 32–81% versus 38–71%
lidocaine
Mohan (2001)‡ Double-blinded Topical VRS 0–2 POD 1 No pain: 10% versus 47% 5
n = 61 ciprofloxacin–dexamethasone POD: 1, 7 Severe pain: 25% versus 0%
versus POD 7 No pain: 74% versus 83%
betamethasone–neomycin Severe pain 0% versus 0%
Paganelli (2004) Double-blinded Topical prednisolone versus sc VRS 0–4 Mean pain: POD 1–7: 0.2–0.6 versus 0.1–0.7 3
n = 100 triamcinolone POD: 1, 3, 7, 14, 28 POD 14–28: 0 versus 0
Russo (2007) Double-blinded Topical dexamethasone with VRS 0–3 Pain: POD 7 p = 0.21; POD 14 p = 0.0033 5
n = 233 netilmycin versus tobramycin POD: 1, 7, 14 Pain values not presented
Donnenfeld (2006) Double-blinded, placebo-controlled Topical ketorolac 3 days versus VRS 1–5 Mean pain: 1.1 versus 1.2 versus 2.0 versus 2.3 5
n = 100 1 day versus 1 hr versus POD: 1 p < 0.001 3 days versus 1 hr and placebo
placebo
Raizman (2007) Double-blinded Two topical prednisolone VRS 0–3 No pain: 94–100% versus 97–100% 4
n = 73 formulations POD: 1, 14, 28 Severe pain: 0% versus 0%
Duong (2007) Double-blinded Topical nepafenac versus VRS 1–5 Mean pain: 1.2 versus 1.5; p < 0.025 4
n = 183 ketorolac POD: 1
Nardi (2007) Randomized, double-blinded, Topical nepafenac versus VRS 0–5 Nepafenac superior to placebo POD 3–28, p < 0.05 4
placebo- and active-controlled ketorolac versus placebo
n = 227 POD: 1, 3, 7, 14, 21, 28 Nepafenac superior to ketorolac POD 3, p = 0.04
Maxwell (2008) Double-blinded Topical nepafenac versus VRS 0–5 No pain: 76–98% versus 52–62%; p < 0.02 4
n = 212 placebo POD: 1, 3, 7, 14
Baiza-Duran (2009) Double-blinded Topical meloxicam versus VRS 0–3 No pain: POD 2: 80% versus 80% 4
n = 146 diclofenac POD: 2, 4, 7, 15, 30 POD 4–15 75–95% versus 70–97%
POD 30: 100% versus 100%
Kaluzny (2010) Double-blinded, active-controlled Preop paracetamol 1 g versus VAS 0–10 Mean pain: 0.6 versus 1.5 4
n = 160 vitamin C 400 mg by mouth VRS 0–4 Severe pain: 1% versus 13%; p < 0.1
POH: 8–12
Donnenfeld (2011) Double-blinded, placebo-controlled Topical ketorolac versus VRS 0–4 No pain: 72% versus 60%; p < 0.001
n = 511 placebo POD: 1–14 daily Rescue analgesia needed: 19% versus 43%; p = 0.001
Resolution of pain: 1 day versus 2 days; p < 0.001
Silverstein (2011) Double-blinded, placebo-controlled Topical bromfenac versus OCGA, 0–3 No pain: 87–95% versus 65–71%; p < 0.0001 4
n = 455 placebo POD 1, 3, 8, 15 Resolution of pain: 2 days versus 4 days§
Bainbridge (1998) Single-blinded Postoperative paraffin-gauze VAS 0–10 POD 1: Severe pain: 19% versus 9% 2
n = 83 pad versus clear plastic shield VRS 0–3
Kongsap (2006) Single-blinded Prechop manual fragmentation NRS 0–10 No pain: 84% versus 94% 3
n = 100 versus phacoemulsification POH: 2 Mean pain: 0.6 (1.1) versus 0.5 (1.3)
Pianini (2010) Randomized, single-blinded Topical dexamethasone with VRS 0–3 No pain: 23% versus 8% 2
n = 80 netilmycin versus tobramycin POD: 7 Severe pain: 45% versus 33%
Dell (2011) Single-blinded Hydrogel ocular bandage NRS 0–10 Mean pain: 1.3 (1.8) versus 1.1 (1.6) 4
n = 420 versus collagen corneal shield POH: 1, 4
Acta Ophthalmologica 2016

11
Acta Ophthalmologica 2016

4.2.7. Risk of bias in included studies

inj = injection, IOL = intraocular lens, NRS = numerical rating scale, NS = no significant difference, OCGA = ocular comfort grading assessment score, POD = postoperative day, POH = postoperative
Quality†
To determine whether there was a need
to exclude any studies from the anal-
3

2
ysis to reduce the study bias, the
instrument developed by Jadad et al.
(1996) to measure the likelihood of
Mean pain at: POH 12.7 versus 5.7; p < 0.005 bias in pain research reports was used.
The instrument includes three ques-
Main results concerning postoperative pain

tions: (1) randomization: yes (1 point)/


Mean pain: 1.4 (1.1) versus 1.4 (1.3) no (0 point), described and appropriate
Most pain: 0.6 versus 1.7; p < 0.001

No pain: 91–100% versus 87–100%


(+1 point)/inappropriate ( 1 point);
Mean pain: 0.0–0.4 versus 0.0–0.4
(2) double blinding: yes (1 point)/no
Severe pain: 0% versus 17%

(0 point), described and appropriate


No pain: 75% versus 43%

(+1 point)/inappropriate ( 1 point);


POD 7: 0.6 versus 0.7

(3) description of withdrawals and


PODl: 2.2 versus 2.5

dropouts: withdrawals stated (+1


point)/no statement on withdrawals (0
points). The evaluation of the selected
studies with these three questions could
yield a score between zero and five
points.
None of the selected studies was
NRS 0–10 Binominal: yes/no

excluded from the analysis, as all stud-


ies obtained evaluation scores of two to
POH: 1, 2, 4, 8, 12, 24

five points (mean 3.5, median 4).


Pain measurement

POD: 1, 3, 7, 15

4.3. Results
hour, sc = subconjunctival, SD = standard deviation, VAS = visual analogue scale, VRS = verbal rating scale.
POD: 1, 7
VAS 0–10

VAS 0–10

VRS 1–10

4.3.1. Study descriptions


POH <1

POD: l

The characteristics of the 21 included


studies are presented in Table 2. Of the
21 RCTs included, 12 trials were dou-
ble-blinded (Mohan et al. 2001; Paga-
Postoperative eye patch versus

Topical dexamethasone versus

Both phacoemulsification and extracapsular cataract extraction techniques used in the study.

nelli et al. 2004; Donnenfeld et al.


tobramycin-dexamethadone
dexamethasone-gentamycin

2006, 2011; Duong et al. 2007; Raiz-


Topical chloramphenicol-

Quality assessment; the result of the use of instrument described by Jadad et al. (1996).
Topical iodine versus sc

betamethasone versus

man et al. 2007; Nardi et al. 2007;


Russo et al. 2007; Maxwell et al.
sc betamethasone
Study intervention

2008; Baiza-Duran et al. 2009;


no patching

Kaluzny et al. 2010; Silverstein et al.


Median time of pain resolution among patients reporting pain at POD 1.

2011), four were single-blinded (Bain-


bridge et al. 1998; Kongsap & Wiriya-
luppa 2006; Pianini et al. 2010; Dell
et al. 2011), four were open-label
(Anders et al. 1999; Heuermann et al.
2000; Stifter & Menapace 2007; Ahmed
et al. 2010; Dieleman et al. 2011), and
Study design and participants

in one RCT, the blinding was not


described (Camesasca et al. 2007). Six-
Blinding not described

teen studies compared the analgesic


efficacy of anti-inflammatory agents,
specifically non-steroidal anti-inflam-
Open study

Open study

Open study

matory agents (NSAIDs; n = 7), corti-


* First author (publication year).

costeroids (n = 8) or paracetamol
n = 400

n = 142
n = 60

n = 60

(n = 1).
Five of the NSAIDs studies were
placebo-controlled (Donnenfeld et al.
Table 2. (Continued)

2006, 2011; Nardi et al. 2007; Maxwell


Camesasca (2007)
Dieleman (2011)

et al. 2008; Silverstein et al. 2011), and


Ahmed (2010)
Stifter (2007)

three were active-controlled (Duong


et al. 2007; Nardi et al. 2007; Baiza-
Study*

Duran et al. 2009). The corticosteroid


studies were active-controlled (Mohan


§

12
Acta Ophthalmologica 2016

et al. 2001; Camesasca et al. 2007; 2007; Raizman et al. 2007, Russo et al. 2008; Baiza-Duran et al. 2009;
Raizman et al. 2007; Russo et al. et al. 2007; Dieleman et al. 2011). Dell et al. 2011; Donnenfeld et al.
2007; Ahmed et al. 2010; Pianini et al. For pain assessment, a verbal rating 2011; Silverstein et al. 2011). There
2010; Dieleman et al. 2011), as was the scale (VRS; n = 16) was the most was one outlier; 53–90% of patients
paracetamol study (Kaluzny et al. commonly used tool, followed by a in the Mohan et al. (2001) study
2010). numerical rating scale (NRS; n = 3), reported pain. However, most patients
Intraocular injections of lidocaine visual analogue scale (VAS; n = 4) and in that study reported only slight pain,
were compared with peribulbar block- ocular comfort grading scale (n = 1). and only, 26% of patients in the
ade in one study (Anders et al. 1999; intervention group, who were treated
Heuermann et al. 2000). Three studies 4.3.2. Incidence and prevalence of post- with ciprofloxacin–dexamethasone
evaluated the eye shields used in post- operative pain ophthalmic suspension, reported sig-
operative care (Bainbridge et al. 1998; 4.3.2.1. Pain in the hospital during the nificant pain versus none in the active
Stifter & Menapace 2007; Dell et al. first hours after surgery. The incidence control group, who were treated with
2011). Two surgical techniques, pha- of ophthalmic pain during the first an ophthalmic suspension of
coemulsification and prechop manual postoperative hours was evaluated in betamethasone–neomycin.
phacofragmentation (Prechop MPF), five studies (Anders et al. 1999; Heuer- First weeks after surgery—The preva-
were compared in one study (Kongsap mann et al. 2000; Kongsap & Wiriya- lence of postoperative pain was eval-
& Wiriyaluppa 2006). luppa 2006; Russo et al. 2007; Kaluzny uated 4–15 days after surgery in eight
Five different NSAIDs were evalu- et al. 2010; Dell et al. 2011). studies (Mohan et al. 2001; Came-
ated: ketorolac (n = 4; Donnenfeld The reported incidence of early- sasca et al. 2007; Nardi et al. 2007;
et al. 2006, 2011; Duong et al. 2007; onset postoperative ocular pain varied Raizman et al. 2007; Maxwell et al.
Nardi et al. 2007), nepafenac (n = 3; significantly between 6% and 95% 2008; Baiza-Duran et al. 2009; Pianini
Duong et al. 2007; Nardi et al. 2007, (Anders et al. 1999; Heuermann et al. et al. 2010; Silverstein et al. 2011).
Maxwell et al. 2008), diclofenac (n = 1; 2000; Kongsap & Wiriyaluppa 2006), Postoperative pain was relatively com-
Baiza-Duran et al. 2009), meloxicam and the incidence of moderate or severe mon in the placebo groups and in the
(n = 1; Baiza-Duran et al. 2009) and pain was 1–35% across the studies intervention groups. In five studies,
bromfenac (n = 1; Silverstein et al. (Stifter & Menapace 2007; Kaluzny the prevalence of pain in the interven-
2011). Of the four corticosteroid agents et al. 2010; Dell et al. 2011). Higher tion groups was between 2% and 26%
evaluated, dexamethasone was used in frequencies of significant pain were and in the placebo groups, between
six studies (Bainbridge et al. 1998; reported in one study evaluating early 29% and 47% (Mohan et al. 2001;
Mohan et al. 2001; Camesasca et al. recovery after surgery. In that study, Nardi et al. 2007; Maxwell et al. 2008;
2007; Russo et al. 2007; Pianini et al. the patients had an intraoperative Baiza-Duran et al. 2009; Silverstein
2010; Dieleman et al. 2011); intracameral injection of lidocaine in et al. 2011). In two studies, pain was
betamethasone in three (Mohan et al. the intervention group and a peribul- reported significantly less frequently,
2001; Camesasca et al. 2007; Dieleman bar injection of prilocaine in the con- with rates of 0–3% at 7–15 days after
et al. 2011); prednisolone in two (Paga- trol group. The incidence of moderate surgery (Nardi et al. 2007; Raizman
nelli et al. 2004; Raizman et al. 2007); or severe pain was 71–85% at 2 hr et al. 2007). The highest prevalence of
and triamcinolone in one study (Paga- after surgery, and 30–36% of the pain was reported in Pianini et al.’s
nelli et al. 2004). patients still reported significant pain (2010) study evaluating the use of
Perioperative pain was the primary at 6 hr (Anders et al. 1999; Heuermann local ointments containing 1 of 2
outcome measure only in one study et al. 2000). antibiotics, netilmicin or tobramycin,
(Kaluzny et al. 2010), and the pres- 4.3.2.2. Pain after discharge. First and dexamethasone in postoperative
ence of postoperative pain was used as 72 hr—The incidence of postoperative care. In that study, 77–92% of
one of the outcome measures in 10 pain during the first 72 postoperative patients had pain at 7 days after
studies (Anders et al. 1999; Mohan hours after discharge was evaluated in surgery and moderate or severe pain
et al. 2001; Nardi et al. 2007; Stifter & 10 studies (Bainbridge et al. 1998; was reported by 33–45%.
Menapace 2007; Maxwell et al. 2008; Mohan et al. 2001; Camesasca et al. The rate decreased during the course
Baiza-Duran et al. 2009; Ahmed et al. 2007; Nardi et al. 2007; Raizman et al. of recovery in all studies. After the first
2010; Pianini et al. 2010; Dell et al. 2007; Maxwell et al. 2008; Baiza- 2 postoperative weeks, the pain was
2011; Silverstein et al. 2011). In these Duran et al. 2009; Dell et al. 2011; measured in three studies, and it
studies, pain after surgery was used to Donnenfeld et al. 2011; Silverstein ranged between 0% and 24% (Nardi
evaluate the efficacy, safety and et al. 2011). After discharge, 40–48% et al. 2007; Raizman et al. 2007; Baiza-
patient comfort or satisfaction of the of the patients in the placebo-treated Duran et al. 2009). In Nardi et al.’s
study interventions. In 10 studies, control groups reported postoperative study, the proportions of patients
perioperative pain was measured pain (Nardi et al. 2007; Maxwell et al. reporting pain at 21 and 28 days after
and/or analgesic consumption was 2008; Donnenfeld et al. 2011). In the surgery were 4–10% in two interven-
reported, although this measure was active intervention groups, pain was tion groups; however, 24–26% of the
not listed as an outcome measure less frequent; 3–42% of patients in placebo-treated patients reported pain.
(Bainbridge et al. 1998; Paganelli these groups had postoperative pain Two studies reported significantly less
et al. 2004; Donnenfeld et al. 2006, after discharge (Bainbridge et al. 1998; postoperative pain as only 0–3% of
2011; Kongsap & Wiriyaluppa 2006; Camesasca et al. 2007; Nardi et al. patients had pain at 4 weeks (Raizman
Camesasca et al. 2007; Duong et al. 2007; Raizman et al. 2007; Maxwell et al. 2007; Baiza-Duran et al. 2009).

13
Acta Ophthalmologica 2016

None of the included studies evaluated Recently, Ahmed et al. (2010) com- lac, at 8% and 20%, compared to the
pain more than 30 days after surgery. pared subconjunctival injection of cor- patients treated with placebo, at 40%
The resolution of pain after surgery ticosteroid-antibiotic solution with and 49%, respectively (Donnenfeld
was evaluated in three studies, all iodine eye drops. Postoperative pain et al. 2006, 2011).
reporting a median time of pain reso- grading was significantly higher in In one study where 1 g of paraceta-
lution of 1 day in the active groups, patients with subconjunctival injection mol taken by mouth before surgery was
whereas the time of pain resolution in of dexamethasone–gentamycin, 5.7/10, compared with 400 mg of vitamin C,
the placebo group was 1 day in one than in patients receiving iodine eye paracetamol appeared to be more
study and 2 days in another (Dell et al. drops, 2.7/10. effective. At 8–12 hr after surgery, only
2011; Donnenfeld et al. 2011; Silver- 4.3.3.2. Severity of postoperative pain one of 80 patients treated with parac-
stein et al. 2011). Silverstein et al. eval- after discharge. The severity of postop- etamol reported moderate or severe
uated pain resolution among patients erative pain after discharge was evalu- pain, while 10 of 80 patients showed
reporting pain during the first 24 hr. In ated in eight studies (Paganelli et al. moderate or severe pain after vitamin
that study, 35% of patients in the 2004; Donnenfeld et al. 2006; Came- C administration (Kaluzny et al. 2010).
placebo group and 13% in the active sasca et al. 2007; Duong et al. 2007; Three studies compared the anal-
group reported pain during the first Raizman et al. 2007; Ahmed et al. gesic efficacy of different NSAIDs
24 hr. Among the patients reporting 2010; Pianini et al. 2010; Dieleman (Duong et al. 2007; Nardi et al. 2007;
pain at 24 hr, the median time to pain et al. 2011). After discharge and up to Baiza-Duran et al. 2009). In the Baiza-
resolution was 4 days in the placebo 4 weeks after surgery, the mean pain Duran et al. (2009) study, the analgesic
group and 2 days in patients treated score measured with VAS or NRS efficacies of meloxicam and diclofenac
with ophthalmic suspension of brom- ranged between 0.6 and 2.5 of 10 were similar. In the two studies evalu-
fenac once daily. (Ahmed et al. 2010; Dieleman et al. ating ketorolac and nepafenac eye
2011). In five studies, postoperative drops (Duong et al. 2007; Nardi et al.
4.3.3. Severity of pain pain was measured with VRS, and 2007), the analgesic efficacy of both
4.3.3.1. Severity of postoperative pain most patients in all studies reported compounds was relatively similar dur-
during early recovery. The severity of no pain or only mild pain (Paganelli ing the first 24 hr after surgery, but
postoperative pain during the first et al. 2004; Donnenfeld et al. 2006; later nepafenac performed better.
hours after surgery was evaluated in Camesasca et al. 2007; Duong et al. Seven studies compared the use of
six studies (Anders et al. 1999; Heuer- 2007; Raizman et al. 2007). different corticosteroid agents or differ-
mann et al. 2000; Stifter & Menapace In one study, more severe pain was ent combinations of corticosteroid and
2007; Ahmed et al. 2010; Kaluzny reported at 7 days. One-third (33%) of antibiotic agents after surgery. The
et al. 2010; Dell et al. 2011). patients who received preservative-free drugs performed equally well at pain
Most patients had only mild or no dexamethasone–netilmicin eye drops, prevention and management in all stud-
pain. In four studies, pain was reported and 45% of patients who received ies, with no significant differences
using a VAS or NRS ranging from preserved dexamethasone–tobramycin reported (Mohan et al. 2001; Paganelli
0 = no pain to 10 = most pain, and the eye drops reported moderate or severe et al. 2004; Camesasca et al. 2007; Raiz-
mean pain scores during the first hours pain (Pianini et al. 2010). man et al. 2007; Russo et al. 2007;
after surgery ranged between 0.5 and Pianini et al. 2010; Dieleman et al.
1.7/10 (Stifter & Menapace 2007; 4.3.4. Management of postoperative pain 2011). One study compared postopera-
Kaluzny et al. 2010; Dell et al. 2011). All study compounds, NSAIDs, corti- tive usage of iodine eye drops with
Although the median pain severity was costeroids, antibiotics and iodine were intraoperative subconjunctival injection
slight, some patients experienced signif- administered topically in ophthalmic of dexamethasone–gentamycin, and
icant postoperative pain. In the Stifter & drugs, except in one study where there was no significant difference in
Menapace (2007) study, one of eight paracetamol was administered by analgesic efficacy after surgery (Ahmed
patients (12%) in the unpatched group mouth 1 hr before surgery (Kaluzny et al. 2010).
had moderate or severe postoperative et al. 2010). Discontinuation rates of the study
pain. In the patched eye group, no 4.3.4.1. Analgesic efficacy of the drugs medications due to a lack of sufficient
moderate or severe pain was reported. used in postoperative care. In all five analgesic efficacy were not reported in
Severe pain was also reported in the studies where NSAIDs were compared any study.
Anders et al. (1999) and Heuermann with placebo, NSAIDs were superior to 4.3.4.2. Adverse effects. Safety of the
et al. (2000) studies, in which the mean placebo (Donnenfeld et al. 2006, 2011; medicines or other interventions was
pain score was moderate in the peribul- Nardi et al. 2007; Maxwell et al. 2008; evaluated in all studies except one
bar group and severe in the intracameral Silverstein et al. 2011). Patients in the (Ahmed et al. 2010). Neither serious
applications. Moreover, severe postop- active groups reported pain signifi- nor severe adverse events or cases of
erative pain was reported by half the cantly less frequently, 5–42% in the endophthalmitis were reported in any
patients who received an intracameral NSAID groups versus 24–48% in the study.
lidocaine injection and by one-third of placebo groups (Nardi et al. 2007; 4.3.4.3. Non-steroidal anti-inflammatory
those who received peribulbar anaes- Maxwell et al. 2008; Silverstein et al. agents. Adverse effects related to
thesia. In that study, pain was reported 2011). The use of rescue analgesics was NSAID therapy were evaluated in all
on a 5-point VRS, where 0 = no pain evaluated in two studies, and in both seven studies (Donnenfeld et al. 2006,
and 4 = most pain (Anders et al. 1999; studies, the need for rescue analgesia 2011; Duong et al. 2007; Nardi et al.
Heuermann et al. 2000). was less in patients treated with ketoro- 2007; Maxwell et al. 2008; Baiza-

14
Acta Ophthalmologica 2016

Duran et al. 2009; Silverstein et al. et al. 2007; Russo et al. 2007; Stifter & possible correlations between pain and
2011). Menapace 2007; Pianini et al. 2010). other ophthalmological findings were
In the three placebo-controlled stud- The most common adverse effects analysed. In one study, there was a
ies, patients in the placebo groups associated with corticosteroid eye drops high correlation between impaired tear
reported more adverse effects than were subconjunctival haemorrhage film break-up time (BUT) and pain
patients treated with topical NSAIDs (Camesasca et al. 2007), IOP elevation sensations during the first 4 hr, but no
(Maxwell et al. 2008; Donnenfeld et al. (Raizman et al. 2007; Pianini et al. later on. That indicates the role of
2011; Silverstein et al. 2011). In the 2001), iritis (Raizman et al. 2007), and postoperative dry eye sensations and
placebo groups, the incidence of adverse the occurrence of white deposits around tear film pathologies in pain during the
effects was 14% in one study, and 41% the eye (Mohan et al. 2001). early recovery. In comparing patients
and 60% in the two other studies com- In three studies, no cases of adverse with and without postoperative pain,
pared to 6%, 25% and 47% in the events were reported in patients treated no significant differences were found in
groups treated with ketorolac, nepafe- with topical corticosteroids (Paganelli IOP, anterior chamber flare, corneal
nac or bromfenac, respectively (Max- et al. 2004; Camesasca et al. 2007; epithelium defects or corneal injections
well et al. 2008; Donnenfeld et al. 2011; Russo et al. 2007). (Stifter & Menapace 2007). In another
Silverstein et al. 2011). In the two recent study, there was no correlation
studies, the proportion of patients who between IOP and postoperative pain
4.4. Discussion
discontinued the study compound (Bainbridge et al. 1998). Topical and
because of adverse events was 3–4 times To our knowledge, this is the first intracameral anaesthetics have differ-
higher in the placebo groups, 16–18%, systematic review evaluating clinical ent efficacy profile to prevent ocular
than in the active groups, 4% and 6% trials of postoperative pain and pain pain (Masket & Gokmen 1998; Fer-
(Donnenfeld et al. 2011; Silverstein management after cataract surgery. An nandez et al. 2009). In addition, it has
et al. 2011). extensive search of the current litera- been documented that some of the
The most commonly reported drug- ture identified 21 studies of pain epi- local anaesthetics may induce interim
related adverse events in patients tak- demiology and pain management after cytotoxic effects on cornea cells (Chang
ing NSAIDs were intraocular pressure cataract surgery, but postoperative et al. 2006; Borazan et al. 2009; Tap-
(IOP) elevation (Donnenfeld et al. pain or postoperative pain manage- peiner et al. 2012). Thus, topical and
2011), eye discomfort, choroidal effu- ment was not a primary aim of any of intracameral local anaesthetics and
sion, eye pain and eyelid margin crust- the identified publications. Moreover, theirs toxic effects may reflect to indi-
ing (Nardi et al. 2007; Maxwell et al. the studies reporting postoperative vidual dependent pain sense that dis-
2008). Duong et al. (2007) suggest that pain yielded inconsistent findings; turbs interpretation of the results
there could be some differences most studies reported no or minimal between different studies.
between NSAIDs in the occurrence of pain after surgery, whereas other stud- Only one study evaluated the use of
adverse effects. In that study, posterior ies reported severe pain and pain systemic analgesics. Paracetamol (1 g)
capsule opacification was reported in lasting a few weeks. Reason for that was compared with vitamin C
5% of patients treated with ketorolac is unclear, but even only studies using (400 mg), both given by mouth 1 hr
and in 14% of patients treated with phacoemulsification technique were before surgery (Kaluzny et al. 2010).
nepafenac. In the Baiza-Duran et al. included in this review, differences in Unfortunately, the dose of vitamin C
(2009) study, meloxicam and diclofe- surgical technique and incision types was relatively small, preventing any
nac eye drops were associated with may affect the surgical trauma and meaningful comparison of these two
similar incidences of adverse effects. postoperative recovery. However, the compounds for this indication (Kanazi
About half of the patients in both most likely reason for inconsistent et al. 2012). Moreover, during the
groups reported a burning sensation findings is the perioperative and post- perioperative period, the absorption
after NSAID instillation, and even operative care of the patients. More of swallowed drugs is erratic and
greater proportions of patients exhib- pain was reported in patients who did delayed, so parenteral dosing is pre-
ited conjunctival hyperaemia. The rate not have eye patch after the surgery ferred in perioperative settings (Kemp-
and severity of these complaints (Stifter & Menapace 2007). Also, intra- painen et al. 2006).
decreased with time. cameral (Anders et al. 1999; Heuer- Most studies evaluated topical
Contrary to most studies, in one mann et al. 2000) and subconjunctival NSAIDs and corticosteroids, which is
evaluating local NSAID eye drops, injections (Ahmed et al. 2010) were rational because all surgical incisions
adverse effects were reported neither associated with significant postopera- are associated with secondary inflam-
in patients treated with NSAIDs nor in tive pain. In one study, the preserva- matory pain. Five different topical
patients treated with placebo (Donnen- tive benzalkonium chloride induced an NSAIDs were used, with no clinically
feld et al. 2006). Moreover, in the increase on IOP that could be one meaningful difference in outcome, indi-
Kaluzny et al. (2010) study, no adverse reason for higher pain incidence and cating that the selection of a NSAID is
effects related to the usage of paracetamol severity in that study (Kongsap & not a critical factor in postoperative
or vitamin C by mouth were reported. Wiriyaluppa 2006). pain management after cataract sur-
4.3.4.4. Corticosteroids. Adverse The incidence of reported pain var- gery (Donnenfeld et al. 2006, 2011;
events related to corticosteroid eye ied between few and over 90% in the Duong et al. 2007; Nardi et al. 2007;
drops were evaluated in seven studies first postoperative hours, and a similar Maxwell et al. 2008; Baiza-Duran
(Mohan et al. 2001; Paganelli et al. variation remained also during the first et al. 2009; Silverstein et al. 2011). In
2004; Camesasca et al. 2007; Raizman week after surgery. In two studies, the all placebo-controlled studies, topical

15
Acta Ophthalmologica 2016

NSAIDs were superior to placebo, ocular drops, and preservative-free for- prophylaxis of endophthalmitis after catar-
indicating high analgesic efficacy (Don- mulas are recommended when possible. act surgery: a multicenter study. Eur J
nenfeld et al. 2006, 2011; Nardi et al. In conclusion, this systematic review Ophthalmol 17: 733–742.
Chang Y-S, Tseng S-Y, Tseng S-H & Wu C-L
2007; Maxwell et al. 2008; Silverstein evaluating clinical trials of postopera-
(2006): Cytotoxicity of lidocaine or bupiva-
et al. 2011). The prevalence of cataract tive pain and pain management after caine on corneal endothelial cells in a rabbit
increases in old age, and most patients cataract surgery indicates that recovery model. Cornea 25: 590–596.
who have the surgery are elderly. after phacoemulsification cataract sur- De Saint Jean M, Brignole F, Bringuier A-F,
Advanced age is a concern in using gery is uneventful in most patients. Bauchet A, Feldmann G & Baudouin C
NSAIDs because elderly patients often However, in some patients, surgery is (1999): Effects of benzalkonium chloride on
experience adverse effects, such as gas- associated with significant postopera- growth and survival of Chang conjunctival
trointestinal irritation and cardiovas- tive pain. These patients should be cells. Invest Ophthalmol Vis Sci 40: 619–630.
Debbasch C, Pisella P-J, De Saint Jean M, Rat
cular complications. Moreover, many provided with appropriate pain man-
P, Warnet J-M & Baudouin C (2001):
elderly patients have absolute con- agement and follow-up instructions. Mitochondrial activity and glutathione
traindications for systemic NSAIDs, Moreover, postoperative pain and pain injury in apoptosis induced by unpreserved
such as compromised renal function, management after cataract surgery and preserved b-blockers on Chang con-
history of gastric ulcers, arterial hyper- have not been evaluated systematically junctival cells. Invest Ophthalmol Vis Sci 42:
tension or heart failure (Gislason et al. in clinical trials; hence, more clinical 2525–2533.
2009). However, small doses of data are needed to understand the Dell SJ, Hovanesian JA, Raizman MB et al.,
NSAIDs are used in topical adminis- implications of postoperative pain for for the Ocular Bandage Study Group (2011):
Randomized comparison of postoperative
tration; thus, the systemic exposure is recovery.
use of hydrogel ocular bandage and collagen
low, and this approach should be safer corneal shield for wound protection and
than NSAIDs given by other adminis- patient tolerability after cataract surgery. J
tration routes (Stewart et al. 2007). Cataract Refract Surg 37: 113–121.
Although topical NSAID eye drops 4.5 References Dieleman M, Wubbels RJ, van Kooten-
are generally safe, local eye irritation, Ahmed MS, Moly KN & Aziz MA (2010): Use
Noordzij M & deWaard PWT (2011): Single
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of povidone-iodine drop instead of sub-
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ular edema after cataract surgery. J Cataract
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mann C (1999): Clinical and electrophysio-
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Bainbridge JWB, Smith JMA, Reddy G &
Donnenfeld ED, Nichamin LD, Hardten DR
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induce cytotoxicity and inflammatory necessary after uncomplicated phacoemulsi-
ketorolac 0.45% for treatment of inflamma-
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tion and pain after cataract surgery. Am J
cells in numerous in vitro and in vivo Baiza-Duran LM, Quintana-Hau J, Tornero-
Ophthalmol 151: 420–426.
Montano R et al. (2009): Comparison of the
models (Rolando et al. 1991; De Saint Duong H-VQ, Westfield KC & Chalkley THF
efficacy and safety of a novel meloxicam
Jean et al. 1999; Debbasch et al. 2001; ophthalmic formulation with a reference
(2007): Ketorolac tromethamine LS 0.4%
Noecker et al. 2004; Pisella et al. 2004; versus nepafenac 0.1% in patients having
diclofenac solution in cataract surgery. Int
Baudouin et al. 2008; Kahook & cataract surgery; prospective randomized
J Clin Pharmacol Ther 47: 89–95.
double-masked clinical trial. J Cataract
Noecker 2008; Leung et al. 2008; Uusi- Baudouin C, Liang H, Hamard P, Riancho L,
Refract Surg 33: 1925–1929.
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Emery JM, Wilhelmus KA & Rosenberg S
Uusitalo et al. 2010). Typical adverse nole-Baudouin F (2008): The ocular surface
(1978): Complications of phacoemulsifica-
effects of eye drops containing BAK of glaucoma patients treated over the long
tion. Ophthalmology 85: 141–150.
term expresses inflammatory markers
include superficial punctuate keratopa- Fernandez SA, Dios E & Diz JC (2009):
related to both T-helper 1 and T-helper 2
thy, epithelial erosions, conjunctival pathways. Ophthalmology 115: 109–115.
Comparative study of topical anaesthesia
hyperaemia, tearing and subjective with lidocaine 2% vs levobupivacaine 0.75%
Borazan M, Karalezli A, Oto S, Akova YA,
painful sensations such as foreign body in cataract surgery. Br J Anaesth 102: 216–
Karabay G, Kocbiyik A, Celasun B &
220.
sensations, itching, burning, stinging Demirhan B (2009): Induction of apoptosis
Gislason GH, Rasmussen JN, Abildstrom SZ
and ocular irritation (Pisella et al. of rabbit corneal endothelial cells by preser-
et al. (2009): Increased mortality and car-
2002; Jaenen et al. 2007). All of these vative-free lidocaine hydrochloride 2%,
diovascular morbidity associated with use of
findings reveal that postoperative pain ropivacaine 1%, or levobupivacaine 0.75%.
nonsteroidal anti-inflammatory drugs in
J Cataract Refract Surg, 35: 753–758; erra-
after cataract surgery not only is asso- chronic heart failure. Arch Intern Med 169:
tum, 1325.
ciated with surgical trauma, operative Camesasca FI, Bianchi C, Beltrame G, Capor-
141–149.
complications or postoperative inflam- Heuermann T, Anders N, Rieck P & Hart-
ossi A, Piovella M, Rapisarda A, Tassinari
mation but also might be related to the mann C (2000): Peribulb€aran€aasthesie ver-
G & Zeppa L, for the Italian Betametha-
sus topische An€asthesie bei der
use of ocular drops containing preser- sone-Chloramphenicol vs Dexamethasone-
Kataraktoperation Vergleich des postopera-
vatives. Thus, pharmaceutical compa- Tobramycin Combination Study Group
tiven Verlaufes [Peribulbaranesthesia versus
nies should develop better-tolerated (2007): Control of inflammation and

16
Acta Ophthalmologica 2016

topical anesthesia in cataract surgery: com- and inflammation associated with cataract Milazzo G (2007): Dexamethasone-netilmi-
parison of the postoperative course]. Oph- surgery. J Ocul Pharmacol Ther 24: 593– cin: a new ophthalmic steroid-antibiotic
thalmologe 97: 189–193. 599. combination. Efficacy and safety after catar-
Higgins JPT & Green S (2011): Cochrane Mohan N, Gupta V, Tandon R, Gupta SK & act surgery. Eye (Lond) 21: 58–64.
Handbook for Systematic Reviews of Inter- Vajpayee RB (2001): Topical ciprofloxacin- Silverstein SM, Cable MG, Sadri E et al.
ventions Version 5.1.0 [updated March dexamethasone combination therapy after (2011): Bromfenac Ophthalmic Solution
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Accessed December 8, 2012. 1975–1978. tion 0.09% for postoperative ocular inflam-
Jadad AR, Moore RA, Carroll D, Jenkinson C, Nardi M, Lobo C, Bereczki A, Cano J, Zagato mation and pain. Curr Med Res Opin 27:
Reynolds DJM, Gavaghan DJ & McQuay E, Potts S, Sullins G & Notivol R, for the 1693–1703.
HJ (1996): Assessing the quality of reports of International C-04-65 Study Group (2007): Stewart RH, Grillone LR, Shiffman ML,
randomized clinical trials: is blinding neces- Analgesic and anti-inflammatory effective- Donnenfeld ED & Gow JA (2007): The
sary? Control Clin Trials 17: 1–12. ness of nepafenac 0.1% for cataract surgery. systemic safety of bromfenac ophthalmic
Jaenen N, Baudouin C, Pouliquen P, Manni Clin Ophthalmol 1: 527–533. solution 0.09%. J Ocul Pharmacol Ther 23:
G, Figueiredo A & Zeyen T (2007): Ocular Noecker RJ, Herrygers LA & Anwaruddin R 601–612.
symptoms and signs with preserved and (2004): Corneal and conjunctival changes Stifter E & Menapace R (2007): ‘Instant
preservative-free glaucoma medications. caused by commonly used glaucoma medi- vision’ compared with postoperative patch-
Eur J Ophthalmol 17: 341–349. cations. Cornea 23: 490–496. ing: clinical evaluation and patient satisfac-
Kahook MY & Noecker RJ (2008): Compar- Paganelli F, Cardillo JA, Melo LAS Jr, tion after bilateral cataract surgery. Am J
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after dosing of travoprost preserved with Ocular Pharmacology and Pharmaceutical Tappeiner C, Flueckiger F, Boehnke M,
sofZia, latanoprost with 0.02% benzalko- Technology Research Group (2004): A sin- Goldblum D & Garweg JG (2012): Effect
nium chloride, and preservative-free artifi- gle intraoperative sub-Tenon’s capsule tri- of topical anesthetic agents and ethanol on
cial tears. Cornea 27: 339–343. amcinolone acetonide injection for the corneoepithelial wound healing in an ex vivo
Kaluzny BJ, Kazmierczak K, Laudencka A, treatment of post-cataract surgery inflam- whole-globe porcine model. J Cataract
Eliks I & Kaluzny JJ (2010): Oral acetami- mation. Ophthalmology 111: 2102–2108. Refract Surg 38: 519–524.
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gesia in phacoemulsification cataract surgery (2010): Efficacy and safety of netilmycin/ Pharmacokinetics, efficacy and safety pro-
performed using topical anesthesia random- dexamethasone preservative-free and tobra- files of preserved and preservative-free taflu-
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Kanazi GE, El-Khatib MF, Yazbeck-Karam Ocul Pharmacol Ther 26: 617–621. Uusitalo H, Chen E, Pfeiffer N et al. (2010):
VG, Hanna JE, Masri B & Aouad MT Pisella PJ, Pouliquen P & Baudouin C (2002): Switching from a preserved to a preserva-
(2012): Effect of vitamin C on morphine use Prevalence of ocular symptoms and signs tive-free prostaglandin preparation in topi-
after laparoscopic cholecystectomy: a ran- with preserved and preservative free glau- cal glaucoma medication. Acta Ophthalmol
domized controlled trial. Can J Anaesth 59: coma medication. Br J Ophthalmol 86: 418– 88: 329–336.
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com/article/10.1007%2Fs12630-012-9692-x. Pisella P-J, Debbasch C, Hamard P, Creuzot- V-P, Virtanen P & Vuorio A; Working
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phen is highly effective in pain treatment served and unpreserved timolol: an ex vivo and Refractive Surgeons (2012): Cataracts.
after endoscopic sinus surgery. Laryngo- and in vitro study. Invest Ophthalmol Vis Current Care Guideline 2010. The Finnish
scope 116: 2125–2128. Sci 45: 1360–1368. Medical Society Duodecim. Available at:
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surgery with topical anesthesia in prechop cal prednisolone acetate 1% formulations in (Accessed on 8 Dec 2012).
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(2008): Prevalence of ocular surface disease National Institute of Health and Welfare, Prospective study on
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http://www.stakes.fi/tilastot/tilastotiedotteet/
postoperative pain after
Martone G, Frezzotti P, Tosi GM et al. 2011/Tr41_11.pdf. (Accessed on 8 Dec 2012). cataract surgery
(2009): An in vivo confocal microscopy Rolando M, Brezzo G, Giordano P, Cam-
analysis of effects of topical antiglaucoma pagna P, Burlando S & Calabria G (1991): Abstract
therapy with preservative on corneal inner- The effect of different benzalkonium chlo-
vation and morphology. Am J Ophthalmol ride concentrations on human normal ocular Purpose: To evaluate postoperative
147: 725–735. surface: a controlled prospective impression pain and early recovery in cataract
Masket S & Gokmen F (1998): Efficacy and cytology study. In: vanBijsterveld OP, Lemp patients.
safety of intracameral lidocaine as a supple- MA & Spinelli D (eds). The Lacrimal Patients and methods: A total of 201
ment to topical anesthesia. J Cataract System; International Symposium on the patients who underwent elective first-
Refract Surg 24: 956–960. Lacrimal System, 6th, 1990, Singapore.
eye cataract extraction surgery were
Maxwell WA, Reiser HJ, Stewart RH, Cava- Amsterdam, the Netherlands: Kugler &
nagh HD, Walters TR, Sager DP & Meuse Ghedini 89–91.
enrolled, and 196 were included in the
PA; The Nepafenac Study Group (2008): Russo S, Papa V, Di Bella A, Favero A, final analysis. The study design was a
Nepafenac dosing frequency for ocular pain Radulescu C, Gafencu O, Carstocea B & single-centre, prospective, follow-up

17
Acta Ophthalmologica 2016

study in a tertiary hospital in eastern studies (Mohan et al. 2001; Pianini asked to participate, and 244 patients
Finland. Postoperative pain was eval- et al. 2010), postoperative ocular irri- agreed. However, for 39 patients, the
uated with the brief pain inventory at tation symptoms were reported by up scheduled operation was cancelled or
four time points: at baseline, and at to 90% of patients. In those studies delayed with an unknown rescheduled
24 hr, 1 week and 6 weeks post- that found postoperative pain, in some time for surgery. Because of complica-
surgery. cases, an uneventful surgery was asso- tions during the phacoemulsification
Results: Postoperative pain was rel- ciated with significant postoperative surgery, four patients had combined
atively common during the first hours pain or other ocular symptoms requir- eye surgery, phacoemulsification with
after surgery, as it was reported by 67 ing immediate pain control (Anders vitrectomy, and were thus excluded
(34%) patients. After hospital dis- et al. 1999; Heuermann et al. 2000; from the analysis. No pre- and post-
charge, the prevalence decreased; at Stifter & Menapace 2007; Mohan et al. operative data were available for five
24 hr, 1 week and 6 weeks, 18 (10%), 2001; Pianini et al. 2010). patients. As a result, 196 patients who
15 (9%) and 12 (7%) patients reported The current evidence indicates that underwent first-eye unilateral cataract
having ocular pain, respectively. Most postoperative pain, when it occurs, can surgery with the phacoemulsification
patients with eye pain reported signif- be slight and have duration of only a technique and intraocular lens implan-
icant pain, with a score of ≥4 on a pain few hours, but more severe or consis- tation (with IOL) were included in the
scale of 0–10, but few had taken tent pain with duration of several days analysis.
analgesics for eye pain. Those who has also been reported (Pianini et al. The surgical technique used was
had used analgesics rated the analgesic 2010). A recent systematic review did phacoemulsification with IOL per-
efficacy of paracetamol and ibuprofen not identify any studies with postoper- formed under local anaesthesia. Eight
as good or excellent. Other ocular ative pain after cataract surgery as a surgeons with an extensive experience
irritation symptoms were common primary outcome measure (Porela-Tii- performed the operations using the
after surgery; as a new postoperative honen et al. 2013). To fill this gap, we same surgical technique, clear cornea
symptom, foreign body sensation was performed a prospective study in which cataract extraction. No premedication
reported by 40 patients (22%), light the primary aim was to evaluate the was used, but the patients were allowed
sensitivity by 29 (16%), burning by 15 incidence and severity of pain and to take their normal medications.
(8%) and itching by 15 (8%). other ocular irritation symptoms after Perioperative medication was as
Conclusion: Moderate or severe cataract surgery with the phacoemulsi- follows:
postoperative pain was relatively com- fication technique and intraocular lens
Prior to surgery
mon after cataract surgery. Thus, all implantation (IOL).
patients undergoing cataract surgery • Tropicamide 5 mg/ml-pheny-
should be provided appropriate coun- lephrine hydrochloride 100 mg/
5.2. Materials and methods
selling on pain and pain management ml drops (prepared by the Kuopio
after surgery. The study design was a prospective University Hospital Pharmacy)
follow-up clinical trial. The protocol
was approved by the Research Ethics
○ twice to each eye.
5.1. Introduction
Committee of the Hospital District of • Cyclopentolate hydrochloride
Cataract surgery is the most common Northern Savo, Kuopio, Finland 10 mg/ml drops (Oftan Syklo;
surgical procedure in ophthalmology (Protocol No 40/2010), and it was Santen Oy, Tampere, Finland)
practice, and the number of surgeries is conducted in accordance with the
assumed to increase in the future principles presented in the Declara-
○ twice to the operated-on eye.
because cataracts are an age-related tion of Helsinki. After receiving oral • Levofloxacin 5 mg drops (Ofta-
condition and life expectancy is and written information, the patients quix; Santen Oy)
increasing in most countries (Salomon gave written consent. Patients under-
et al. 2012). The high number of surg- went surgery between October 2009
○ four times to each eye.
eries performed is also due to good and September 2011 at the Kuopio • 1–2 drops of tetracaine gel 40 mg/
outcomes for the surgical treatment of University Hospital, Kuopio, Fin- ml (Ametop; Smith and Nephew,
cataracts. land. Hull, UK).
The modern minimally invasive cat- We enrolled adult patients who pre- • Washing with povidone-iodine
aract surgery technique with pha- sented to the hospital for elective first- 50 mg/ml (Betadine; Alcon Labo-
coemulsification is considered to be a eye unilateral cataract surgery per- ratories Inc., Fort Worth, TX,
minor procedure with an uneventful formed under local anaesthesia. We USA).
and pain-free recovery period. How- did not enrol patients who planned to
ever, in the published studies, little have the surgery under general anaes- Intracameral
attention has been paid to pain and thesia or those who had dementia or • Sodium hyaluronate 7000 14 mg/
other postoperative ocular irritation other diseases that could have impaired ml (Healon GV OVD; Abbott
symptoms, and the data on the inci- their memory or cognitive function. In Medical Optics Inc., Santa An,
dence of these symptoms are conflict- addition, we excluded patients who had CA, USA).
ing. For example, in two studies any major psychiatric disease that • 1.5 mg of cefuroxime 10 mg/ml
(Camesasca et al. 2007; Raizman et al. could have affected their ability to (prepared by the Kuopio Univer-
2007), few patients reported any com- complete the study questionnaires. A sity Hospital Pharmacy).
plaints after surgery, whereas in other total of 303 consecutive patients were

18
Acta Ophthalmologica 2016

Postoperative (NRS) scored 0–10, where 0 = best out- using statistical software (IBM SPSS
come/does not interfere/no pain/com- Statistics 19; IBM, Armonk, NY,
• Chloramphenicol 2 mg/ml–hy-
plete pain relief and 10 = worst USA). For binary dependent variables,
drocortisone 5 mg/ml drops
outcome/completely interferes/most we used McNemar’s chi-square test,
(Oftan C–C; Santen Oy)
pain/no pain relief. Ten additional ques- and for nominal variables, we used the
○ three times per day for 3 weeks. tions concerned ocular irritation symp- Wilcoxon signed-rank test. A two-sided
toms, and some yes/no and open-ended p-value of <0.05 was considered statis-
Additional anaesthesia was used in questions were also used to evaluate the tically significant.
two patients, topical tetracaine gel in presence and severity of eye pain and
one patient and lidocaine gel topical other ocular symptoms, including itch-
5.4. Results
and intracameral in one patient. Four ing, foreign body sensation and burning.
patients had a parabulbar blockade, Patients were asked about their use and 5.4.1. Patient characteristics
and one regional anaesthesia was con- the efficacy of analgesics and whether In total, 196 patients, 68 men and 168
verted to general anaesthesia; this analgesics were used for ophthalmic women, aged between 40 and 91 years
patient was included into the intent to pain, for other eye symptoms or for (median 74) were included in the final
treat analysis. other bodily pain. analysis. Not all patients completed
No routine postoperative pain med- The preoperative questionnaires all postoperative questionnaires, but
ication was prescribed, but patients were sent to patients with an invitation some postoperative data were avail-
who were in pain while in the recovery letter, and patients were asked to bring able for 186 patients, giving a
area were allowed to have ibuprofen, if the completed questionnaires with response rate of 95%. All three post-
not contraindicated, and paracetamol them when they travelled to the hospi- operative questionnaires were com-
by mouth, as needed. tal for the surgery. In hospital, the pleted by 164 patients. The study
Postoperative aftercare instructions completed questionnaires were checked questionnaires were completed by
were given according to the normal by a study nurse to ensure the com- 179 patients at 24 hr, 174 patients at
protocol of the hospital. For the first pleteness of the data. 1 week and 170 patients at 6 weeks.
24 hr after cataract surgery, an eye The perioperative data, recovery in One patient died before the end of the
shield was placed over the operated-on hospital, and pain and other symptoms 6-week follow-up period, and the
eye. Patients were informed to avoid at hospital discharge were collected autopsy indicated that he had coro-
hair washing for 2 days to keep water prospectively with a structured study nary thrombosis.
out of the operated-on eye. They were form, and missing data were searched In total, 93% (183/196) of patients
instructed to avoid any strenuous activ- for and recorded from the patients’ had one or more concomitant medical
ity, heavy lifting, swimming or sauna use medical records. conditions, with circulatory system dis-
for the first week after surgery. A post- At hospital discharge, patients were eases being the most common, reported
operative visit was scheduled for given three sets of questionnaires and by 76% (149/196) of patients; 50/196
1 month after surgery, and the patients prepaid postal envelopes in which to (26%) had arthritis or other diseases of
were provided contact information to return the completed questionnaires. the musculoskeletal system or connec-
use if ocular complaints appeared ear- Patients were asked to fill out the BPI tive tissue. In addition to cataracts,
lier. At the time of hospital discharge, at 24 hr, 1 week and 6 weeks after the other ophthalmological conditions/dis-
patients were not prescribed pain med- surgery. After the questionnaires had eases were observed in 28 of the 196
ication. been completed, the patients were to patients (14%), including glaucoma
The data were collected using a return all questionnaires at same time (n = 16), retinopathy or maculopathy
structured study form and a question- with the prepaid envelope. Non-respon- (n = 5), retinitis pigmentosa (n = 2),
naire at baseline, during the periopera- ders were contacted by phone at 8– cornea dystrophy (n = 2), chronic con-
tive period in hospital, and at 24 hr, 10 weeks after surgery, and they were junctivitis (n = 1), chronic iritis (n = 1)
1 week and 6 weeks after surgery. The asked to return the completed question- and retinal detachment (n = 1). Regular
structured study questionnaire was naires or were interviewed over the medications were used by 93% (182/
developed to gather data on patients’ phone. Due to the prospective nature 196) of patients, 43% (85/196) used
preoperative medical history and med- of the study, only data from 6 weeks analgesics and 3% (5/196) used tear
ications in use, bodily and ocular pain, after surgery were available for patients substitutes.
and other eye symptoms at baseline. The who did not complete the questionnaires A postoperative rise of intraocular
questionnaire was pretested in ten pilot at 24 hr or at 1 week (n = 4). pressure requiring medication was
patients to ensure that the patients were The primary outcome measure was noted in four patients. One patient
able to understand the questions and the presence and severity of pain and had iris prolapse, and one patient had
complete the questionnaire accurately. other ocular irritation symptoms after subconjunctival haemorrhage. Iris
The short form of the Brief Pain Inven- cataract surgery. The secondary out- retractors were used in two patients to
tory (BPI; Daut et al. 1983) was used to come measures were the use and effi- enforce mydriasis. These patients were
evaluate the severity of pain, the impact cacy of analgesics. all included in the analysis.
of pain on daily function, the location of
pain, the pain medications used and the 5.4.2. Pain
5.3. Statistics
amount of pain relief in the previous The prevalence and severity of postop-
24 hr. Answers were given using The data were entered, and descriptive erative ocular pain are presented in
an eleven-point numeric rating scale and statistical analysis was performed, Fig. 4 and Table 3.

19
Acta Ophthalmologica 2016

any analgesics for ocular symptoms,


but three had taken analgesics for other
bodily pain.
At 6 weeks after surgery, 12 of 170
patients (7%) reported pain, and the
median pain score was 3–4 of 10. Five
patients had used analgesics for ocular
pain.

5.4.3. Other ocular symptoms


Ocular symptoms, such as itching,
burning, light sensitivity and foreign
body sensation, were common both
before and after surgery (Table 4).
Approximately half of the patients,
56% (110/196), reported ocular symp-
toms before surgery, with itching
(n = 43) and foreign body sensation
(n = 43) being the most common symp-
toms at baseline. At 24 hr after sur-
gery, the prevalence of ocular irritation
symptoms was similar to that at base-
line, but at 24 hr, foreign body sensa-
tion (n = 47) was more common, as
was burning (n = 31), than at baseline.
Thereafter, there was a slight decline in
the prevalence of ocular symptoms, but
Fig. 4. Prevalence of ocular pain.
even at 6 weeks, one-third (65/170) had
irritation symptoms. Most patients had
At baseline before the surgery, eight reported significant pain (NRS ≥ 4/ mild symptoms, but moderate or severe
patients (4%) reported ocular pain, 10). symptoms (NRS ≥ 4/10) were reported
and one of them had ocular pain at After hospital discharge, less ocular by 33/179 patients (18%) at 24 hr, by
every follow-up; the other seven pain was reported (p = 0.001), but the 16/174 (9%) at 1 week and by 19/170
patients did not report any postopera- number of patients with significant (11%) at 6 weeks after surgery.
tive pain. pain remained relatively constant dur- When the patients were asked which
At the hospital during the first post- ing the 6-week study period. of the ocular symptoms had developed
operative hours, 34% (67/196) of At 24 hr after surgery, 18 of 179 after surgery, 45% (84/186) reported
patients reported ocular pain. Most patients (10%) reported ocular pain, new symptoms. Foreign body sensa-
had mild pain, but 18 patients had and most of them had moderate pain, tion was reported as a new symptom by
moderate or severe pain, corresponding with a median of pain score 4–5/10. 22% (40/186) of patients, light sensi-
to a pain score of 4 or more on the However, only eight of these 18 tivity by 16% (29/186), burning by 8%
eleven-point NRS. However, only five patients in pain had taken any anal- (15/186) and itching by 8% (15/186).
patients were given analgesics, includ- gesics.
ing paracetamol by mouth (n = 4) and At 1 week after surgery, 15 of 174 5.4.4. Analgesics
diclofenac eye drops (n = 1). At the patients (9%) reported pain, and the At baseline, analgesics were used by 85
time of hospital discharge, 27% (53/ median pain score was 4 of 10. None of patients (43%) for different indica-
194) had ocular pain, and nine of them the patients with ocular pain had taken tions. After surgery, 46 patients (25%)

Table 3. Postoperative pain after surgery.

In hospital At discharge At 24 hr At 1 week At 6 weeks


Variable (n = 196) (n = 194) (n = 179) (n = 174) (n = 170)

Patients with ocular pain* 67 (34) 53 (27) 18 (10) 15 (9) 12 (7)


NRS pain score >4/10* 18 (9) 9 (5) 13 (7) 8 (5) 6 (4)
Current pain, for those in pain (NRS 0–10)† 2.8 (1.9) 2.1 (1–4) 3.9 (1.5) 3.1 (1.7) 3.5 (1.8)
2 [1–7] 2 [1–6] 4 [2–6] 4 [1–6] 4 [1–6]
Average pain during the last 24 hr (NRS 0–10)† 4.3 (1.7) 3.5 (2.2) 3.3 (1.6)
4 [2–7] 3 [1–8] 3 [1–6]
Most pain during the last 24 hr (NRS 0–10)† 4.9 (1.5) 4.1 (2.6) 4.3 (2.1)
5 [2–7] 4 [1–10] 4 [2–8]

The numeric rating scale (NRS) was scored 0–10, where 0 = no pain and 10 = most pain.
Data are expressed as *number of patients (%), †mean (SD) and median [range].

20
Acta Ophthalmologica 2016

Table 4. Ocular symptoms before and after surgery. such as diabetes mellitus, hypertension,
rheumatoid disease, thyroid dysfunc-
At baseline At 24 hr At 1 week At 6 weeks
Variable (n = 196) (n = 179) (n = 174) (n = 170)
tion, psychiatric disease and cancer and
with the drugs used to treat these
Patients with any ocular 105 (54) 93 (52) 79 (45) 65 (38) diseases. All these conditions increase
irritation symptoms the severity of dry eye and its associ-
Ocular symptoms ated symptoms. In the present study,
Foreign-body sensation 43 (22) 47 (26) 33 (19) 26 (15) the prevalence of concomitant disease
Itching 43 (22) 21 (12) 25 (14) 21 (12) was high, as expected; 76% of patients
Burning 23 (12) 31 (17) 19 (11) 20 (12)
had cardiovascular disease, and 36%
Photosensitivity 3 (2) 9 (5) 7 (4) 19 (11)
Tearing 19 (10) 8 (4) 2 (1) 4 (2) had endocrine, nutritional or metabolic
disease.
Data are number of patients (%). The elderly population presents
challenges for pain assessment and
management due to the subjective
used analgesics for postoperative ocu- contrast to the current study, less pain nature of pain and the limitations of
lar pain or other painful ocular symp- was reported in a study by Kaluzny ascertaining pain severity. Ageing may
toms. The most frequently used et al. (2010). They compared paraceta- affect pain perception and expression.
analgesics were paracetamol (n = 33) mol and vitamin C for pain prevention Thus, different approaches are needed
and ibuprofen (n = 10). The analgesic in cataract surgery, and less than 10% for pain assessment, and this is also the
efficacy of the compounds was rated as of patients were reported to have any case for cataract surgery, for which
good or excellent; on an eleven-point pain. In our study, one-third of tools based on visual function are not
NRS, where 0 = no pain relief and patients reported some pain during optimal. Ocular irritation symptoms
10 = complete pain relief, the analgesic the early hours, and the majority of are common after eye surgery, and it
efficacy was rated to be between 5 of 10 these patients (79%) left the hospital can be difficult to distinguish these
and 10 of 10, with no difference with a pain symptom remaining. To symptoms from postoperative pain. In
between the two drugs. prevent unnecessary suffering, patients the present study, half of the patients
The analgesics were well tolerated, with significant postoperative pain or reported some new ocular irritation
and no serious or unexpected adverse other ocular symptoms must be identi- symptoms after surgery, and one-fifth
events were reported. Four patients fied, and appropriate counselling and had moderate or severe symptoms.
reported five mild adverse effects: clear instructions on analgesic use Unfortunately, we asked the patients
naproxen was associated with dry should be provided. only the severity of the symptoms and
mouth, sweating and constipation, In this study, we showed that post- not the level of unpleasantness.
and ibuprofen was associated with operative ocular irritation symptoms According to the definition of the
sweating and headache. and pain after cataract surgery vary International Association for the Study
between individuals and vary in dura- of Pain, pain is ‘an unpleasant sensory
tion. Some patients had severe pain and and emotional experience associated
5.5. Discussion
other irritation symptoms lasting up to with actual or potential tissue damage,
This was one of the first studies with 6 weeks, whereas most patients recov- or described in terms of such damage’
postoperative pain as a primary out- ered with no or only minor and short- (Bonica 1979). According to this defi-
come measure after cataract surgery. lasting postoperative complaints. Ocu- nition, pain is a subjective, unpleasant
The data indicate that pain and other lar irritation symptoms are common sensorial and emotional experience. As
ocular symptoms are common after after cataract surgery. In the present a third component, in addition to
cataract surgery with the phacoemulsi- study, half of the patients reported sensory and affective dimensions, pain
fication technique. Some patients (9%) different ocular symptoms. These local has a cognitive dimension, that is
reported significant pain, and moderate symptoms, such as foreign body sensa- patients give meanings to the postop-
or severe irritation symptoms were tion, pruritus, irritation, itching, light erative complaints they have. Elderly
common (18%) during the early hours sensitivity and blurred vision, are usu- surgical patients may consider some
of recovery at the hospital, but only ally considered as ocular symptoms ocular irritation symptoms to be
few patients were provided analgesics. rather than pain by the ophthalmologist related to surgery, and even though
These data are consistent with recent (Dell et al. 2011). Therefore, mild or the symptoms may be unpleasant and
data reported in a cohort study under- moderate pain may be misdiagnosed severe, as was the case in the present
taken as a part of quality improvement and interpreted to be involved with study, these symptoms are not called
registry, from Germany. In that study, ocular symptoms and thus may not be pain. Therefore, each individual has a
the median of worst pain during the treated with analgesics. different use of the word pain, and
first 24 hr after eye surgery was 2/10, Individuals undergoing cataract sur- elderly individuals may use euphe-
and the 25th and 75th percentiles were gery are usually elderly individuals who misms when reporting pain conditions,
0/10 and 5/10, respectively (Gerbersha- have different severity levels of dry eye making pain assessment a challenging
gen et al. 2013). However, in that syndrome and various other ocular task in clinical work.
study, different types of eye surgery symptoms (Erb et al. 2008). These The selection of an appropriate
were included, and the number of ocular irritation symptoms may be analgesic is also an issue for elderly
cataract surgeries was not reported. In associated with concomitant diseases, individuals. Most elderly patients

21
Acta Ophthalmologica 2016

have concomitant diseases and use article critically for important intellec- clinical trial. J Cataract Refract Surg 27:
medications, as observed for 93% of tual content. 1975–1978.
patients in the present study. Both Pianini V, Passani A, Rossi GC & Passani F
(2010): Efficacy and safety of netilmycin/
age- and disease-related changes in
5.9. Disclosure dexamethasone preservative-free and tobra-
physiology and drug interactions mycin/dexamethasone-preserved fixed com-
should be taken into account when The authors report no conflict of bination in patients after cataract surgery. J
prescribing analgesics to elderly interests in this work. Ocul Pharmacol Ther 26: 617–621.
patients. However, most cataract sur- Porela-Tiihonen S, Kaarniranta K & Kokki H
gery patients had only mild or mod- (2013): Postoperative pain after cataract
erate pain, and thus, commonly used surgery. J Cataract Refract Surg 39: 789–798.
non-opioid analgesics, such as parac-
5.10 References Raizman MB, Donnenfeld ED & Weinstein
AJ (2007): Clinical comparison of two topi-
etamol and traditional non-steroidal Alam A, Gomes T, Zheng H, Mamdani MM, cal prednisolone acetate 1% formulations in
anti-inflammatory drugs (NSAIDs), Juurlink DN & Bell CM (2012): Long-term reducing inflammation after cataract sur-
are appropriate choices for short-term analgesic use after low-risk surgery: a retro- gery. Curr Med Res Opin 23: 2325–2331.
use. However, care should be taken to spective cohort study. Arch Intern Med 172: Salomon JA, Wang H, Freeman MK et al.
ensure that the patients understand 425–430. (2012): Healthy life expectancy for 187
Anders N, Heuermann T, R€ uther K & Hart-
they should use the lowest effective countries, 1990–2010: a systematic analysis
mann C (1999): Clinical and electrophysio- for the Global Burden Disease Study 2010.
dose for the shortest time needed. It logic results after intracameral lidocaine 1%
has been shown that there is a high Lancet 380: 2144–2162.
anesthesia: a prospective randomized study. Stifter E & Menapace R (2007): ‘Instant
risk that analgesics intended for short- Ophthalmology 106: 1863–1868. vision’ compared with postoperative patch-
term use will be used for prolonged Bonica JJ (1979): The need of a taxonomy. ing: clinical evaluation and patient satisfac-
periods. In a recent study, there was a Pain 6: 247–248. tion after bilateral cataract surgery. Am J
four- to fivefold higher risk of becom- Camesasca FI, Bianchi C, Beltrame G et al.; Ophthalmol 143: 441–448.
ing a long-term NSAID user if Italian Betamethasone-Chloramphenicol vs
Dexamethasone-Tobramycin Combination
NSAIDs were prescribed for postop-
erative pain after cataract surgery
Study Group (2007): Control of inflamma-
tion and prophylaxis of endophthalmitis
6. Publication III.
than if there was no NSAID prescrip- after cataract surgery: a multicenter study. Recovery and patient
tion (Alam et al. 2012). Eur J Ophthalmol 17: 733–742.
Daut RL, Cleeland CS & Flanery RC (1983):
satisfaction after
Development of the Wisconsin Brief Pain cataract surgery: A
5.6. Conclusion Questionnaire to assess pain in cancer and
other diseases. Pain 17: 197–210.
1-year prospective
In conclusion, at least one out of ten
patients can have significant pain after Dell SJ, Hovanesian JA, Raizman MB et al.; follow-up study
Ocular Bandage Study Group (2011): Ran-
cataract surgery, and one-fifth can have domized comparison of postoperative use of 6.1. A letter to the editor
other moderate or severe ocular irrita- hydrogel ocular bandage and collagen cor-
tion symptoms, which may last up to neal shield for wound protection and patient Editor,
6 weeks in some patients. Thus, patients tolerability after cataract surgery. J Cataract Recovery after modern phacoemul-
should be provided appropriate coun- Refract Surg 37: 113–121. sification cataract surgery is often con-
selling on pain and pain management as Erb C, Gast U & Schremmer D (2008): sidered to be straightforward.
part of routine postoperative care, and German register for glaucoma patients with However, the type and frequency of
dry eye. I. Basic outcome with respect to dry
they should be given information on postoperative complaints and the
eye. Graefes Arch Clin Exp Ophthalmol
who to contact if problems arise after 246: 1593–1601.
effects of these on patients’ satisfaction
hospital discharge. Gerbershagen HJ, Aduckathil S, van Wijck with cataract surgery have not been
AJ, Peelen LM, Kalkman CJ & Meissner W fully established (Porela-Tiihonen
(2013): Pain intensity on the first day after et al. 2013). On a prospective longitu-
5.7. Acknowledgements
surgery: a prospective cohort study compar- dinal clinical trial, we have evaluated
The study was financially supported by ing 179 surgical procedures. Anesthesiology the patient-reported visual outcome
the governmental EVO-fund, Kuopio 118: 934–944. and satisfaction at 12 months after
Heuermann T, Anders N, Rieck P & Hart-
University Hospital, Kuopio, Finland, cataract surgery and surveyed the com-
mann C (2000): Peribulbar anesthesia versus
and by the University of Eastern Fin- topical anesthesia in cataract surgery: com-
plaints that patients might have after
land, Kuopio, Finland. parison of the postoperative course. Oph- cataract surgery, and tried to identify
thalmologe 97: 189–193. German. the factors that affect the patient-
Kaluzny BJ, Kazmierczak K, Laudencka A, reported treatment outcome.
5.8. Author contributions
Eliks I & Kaluzny JJ (2010): Oral acetami- The protocol was approved by the
All authors participated in the concep- nophen (paracetamol) for additional anal- Local Research Ethics Committee, and
tion and design of the study, acquisition gesia in phacoemulsification cataract surgery a written consent was obtained from all
performed using topical anesthesia Ran-
of data, analysis and interpretation of participants. A total of 196 consecutive
domized double-masked placebo-controlled
data; and approved the final version to trial. J Cataract Refract Surg 36: 402–406.
patients who underwent phacoemulsi-
be published. SP-T and HK drafted the Mohan N, Gupta V, Tandon R, Gupta SK & fication and intraocular lens implanta-
first version of the article. KK partici- Vajpayee RB (2001): Topical ciprofloxacin- tion under topical anaesthesia were
pated in drafting the article. MK and dexamethasone combination therapy after included, and the follow-up data at
SP-T participated in reviewing the cataract surgery: randomized controlled 12 months were available for 164

22
Acta Ophthalmologica 2016

patients; five patients had died, and 27 79%) than those who were satisfied item short-form Rasch-scaled revision of the
were lost to follow-up. Thirty-three (44/112, 39%, p = 0.001). Postopera- Catquest questionnaire. J Cataract Refract
patients had ocular comorbidities: tive ocular symptoms are presented at Surg 35: 504–513.
Porela-Tiihonen S, Kaarniranta K & Kokki H
glaucoma (n = 15), diabetic retinopa- Table 5. Patients who reported better
(2013): Postoperative pain after cataract
thy or maculopathy (n = 6), or other visual function at baseline with Cat- surgery. J Cataract Refract Surg 39: 789–
(n = 12), and were excluded from the quest-9SF were more likely to be sat- 798.
analysis. A total of 131 patients were isfied with treatment outcome at Uusitalo RJ & Tarkkanen A (1998): Outcomes
included in the final analysis. 12 months than those with greater of small incision cataract surgery. J Cataract
Vision-related disability in everyday baseline visual function impairment Refract Surg 24: 212–221.
life was evaluated with the visual func- [p = 0.012, logistic regression analysis, Uusitalo RJ, Brans T, Pessi T & Tarkkanen A
tioning index VF-7 (Uusitalo et al. OR 1.5 (95% CI 1.1, 2.1)]. Life satis- (1999): Evaluating cataract surgery gains by
assessing patients’ quality of life using the
1999) and Catquest-9SF (Lundstr€ om faction was reported as good or very
VF-7. J Cataract Refract Surg 25: 989–994.
& Pesudovs 2009). For background good by 87% at baseline and by 85%
data, we recorded the patient’s demo- at 12 months. Patients who underwent
graphics data, medical history, medi- cataract surgery in the second eye
cations, ocular symptoms and other within the 12 month follow-up period 7. Publication IV.
bodily pain symptoms. Patient’s satis- reported greater life satisfaction Health-related quality of
faction with health and life in general (p < 0.001). At baseline 15 (11%) life after cataract surgery
was tested on a five-point Likert scale. patients and at 12 months, three (2%)
Patients, 87 females and 44 males, patients reported ocular condition- or with phacoemulsification
median of 73 years (40–91), were oper- vision-related distress (p = 0.02). technique and intraocular
ated between October 2010 and August The main findings were that patients lens implantation
2011. The second-eye cataract surgery with better visual function at baseline
was performed in 87 of 131 (66%) were more satisfied with the outcome, Abstract
patients during the first postoperative whereas the presence of postoperative
year. During the follow-up period, 21 ocular symptoms was related to lower Purpose: Disease-specific instruments
patients underwent 24 additional oph- patient satisfaction at 12 months after have shown significant gains in mea-
thalmological procedures: a YAG-laser the first-eye cataract surgery. In our suring health-related quality of life
capsulotomy (n = 6), argon laser pho- study, 85% of patients were satisfied (HRQoL) in subjects having cataract
tocoagulation (n = 5), vitrectomy with the treatment outcome, which is surgery. However, the usage of generic
(n = 5) or other (n = 8). similar to previous findings (Uusitalo & instruments has resulted in conflicting
In the Catquest-9SF-questionnaire, Tarkkanen 1998). Patients who under- evidence.
the gain in visual function was signif- went cataract surgery also in the sec- Methods: In this prospective study,
icant in all nine dimensions (p < 0.001, ond eye were more satisfied than we have evaluated the impact of
t-test) and the mean item score patients with first-eye surgery only. cataract surgery on subjects’ HRQoL
improved from 0.54 (SD 1.5) at The main limitations of the present measured with a 15-dimension generic
baseline to 3.1 (1.2; p < 0.001) at study were the exclusion on complex instrument, the 15D. The HRQoL of
12 months. In the VF-7, patients cases and a relatively small sample size. cataract subjects was compared with
reported significantly less (p < 0.01, Thus, further studies are needed to that of an age- and gender-standar-
McNemar test) difficulty in performing confirm these findings. dized sample of the general population
daily activities 12 months after surgery in Finland. A total of 152 subjects
for all except one, that is driving a car. (mean age 74 years, 66% females) with
Most patients were satisfied with the a first-eye cataract surgery completed
treatment. Nineteen patients (15%)
6.2 References the 15D questionnaire both before and
who were dissatisfied reported signifi- Lundstr€
om M & Pesudovs K (2009): Catquest- 12 months after cataract surgery.
cantly more ocular symptoms (15/19, 9SF patient outcomes questionnaire: nine- Results: When compared with the
general population, cataract subjects
had much lower HRQoL at baseline
Table 5. Ocular symptoms before and after surgery. [mean difference 0.037 (95% CI: 0.020,
0.054), p < 0.001]. At 12 months after
At baseline At 12 months p-Value cataract surgery, the overall utility
Variable (n = 131) after surgery (n = 131) (McNemar test) index improved from the mean of
0.837 to 0.855 [mean difference 0.018
Patients with any 73 (56) 59 (45) 0.009
symptoms (%)
(95% CI: 0.007, 0.029), p = 0.002].
Ocular symptoms (%) Significant improvement was observed
Itching 25 (19) 29 (22) 1.000 on the following five dimensions: see-
Foreign-body sensation 9 (7) 15 (11) 0.286 ing, moving, hearing, usual activities
Burning sensation 23 (18) 17 (13) 0.169 and discomfort/symptoms in the 15D
Tearing 16 (12) 11 (8) 0.210 questionnaire.
Ocular pain 5 (4) 6 (5) 1.000 Conclusion: Our data indicate that at
Photophobia 2 (2) 5 (4) 0.453
12 months after first-eye cataract sur-
Data are presented as the number of patients (%). gery, patients’ HRQoL is slightly better

23
Acta Ophthalmologica 2016

than that before surgery. However, tively between 2010 and 2012 in the The 15D includes the following 15
patients’ postoperative HRQoL may Kuopio University Hospital (KUH). dimensions, which have five levels each:
remain lower than that of an age- and The study is part of a large study moving, seeing, hearing, breathing,
gender-standardized control population. setting, and some results have been sleeping, eating, speech, excretion,
Keywords: Cataract – Cataract sur- previously published (Porela-Tiihonen usual activities, mental function, dis-
gery – Quality of life – Quality-adjusted et al. 2013, 2015). comfort and symptoms, depression,
life years Initially, 303 consecutive patients distress, vitality and sexual activity.
who presented for cataract surgery The valuation system is based on an
were asked to participate. Of these, application of the multi-attribute utility
7.1. Introduction
196 (65%) agreed to participate and theory. The single index score (15D
Cataract surgery is highly effective at had an elective first-eye cataract sur- score), representing the overall
reversing visual impairment. A signifi- gery in the year 2010 or 2011. The HRQoL on a 0–1 scale (1 = full health,
cant improvement in cataract patients’ follow-up questionnaire was mailed to 0 = being dead), and the dimension
daily activities and in vision-related subjects 12 months after surgery and level values, reflecting the subject’s
quality of life (QoL) has been shown included a prepaid envelope for return- reported level relative to no problems
with disease-specific instruments ing the questionnaire. Cataract subjects on the dimension (=1) and to being
(Steinberg et al. 1994a,b; Lundstr€ om who did not return the questionnaire dead (=0), are calculated from the
& Pesudovs 2009; McAlinden et al. within 2 weeks were contacted and health state descriptive system using a
2011). However, the usage of generic interviewed by phone. Preoperative set of population-based preference or
instruments for health-related quality data were available for 182 (93%) utility weights (Sintonen 1995).
of life (HRQoL) assessment is neces- subjects, and 152 returned the follow- The minimally important change of
sary to be able to compare outcomes up questionnaire at 12 months and the 15D score is 0.015, and the distri-
after cataract surgery with other pro- were included in the final analysis, bution of changes of the 15D scores
cedures and health conditions from ending up to a response rate of 84%. (postoperative score – baseline score) is
other medical specialties (Damiano The trial profile is presented as a divided into the following five cate-
et al. 1995; Gold et al. 1996; Ramsey flowchart in Fig. 5. gories: >0.035 for ‘much better’, 0.015–
et al. 2005; Nord et al. 2009; Wisløff For background information, we 0.035 for ‘slightly better’, greater than
et al. 2014). Previous analyses using collected age and sex data. Further- 0.015 and <0.015 for ‘much the same
generic instruments for HRQoL assess- more, the patient records were searched (no change)’, 0.035 to 0.015 for
ment have yielded inconsistent results for information on whether the sub- ‘slightly worse’ and less than 0.035
in cataract subjects (Steinberg et al. jects had a second-eye cataract surgery for ‘much worse’. These values are
1994a,b; R€as€anen et al. 2006; Brown or other ophthalmological surgical pro- based on data of altogether 4903 hos-
et al. 2013; Danquah et al. 2014). cedures during the 12-month follow-up pital patients representing 16 disease
Due to conflicting evidence, we per- time. The HRQoL was measured at entities and having the 15D score at
formed a prospective follow-up study baseline before surgery and at baseline repeated the HRQoL assess-
in subjects having cataract surgery with 12 months after surgery with a self- ment at 6 months after treatment and
a phacoemulsification technique in a administered standardized instrument, answered the question: compared to
tertiary hospital in Finland. The pri- the 15D (Sintonen 1994, 1995, 2001). the situation before treatment, my
mary aim of this study was to evaluate
the impact of cataract surgery on
patients’ HRQoL measured with a 15-
dimension generic instrument, the 15D
(Sintonen 1995). The second aim was
to compare HRQoL of patients under-
going cataract surgery with that in an
age- and gender-standardized sample
of the general population in Finland.

7.2. Materials and methods


The study design was a prospective
follow-up study. The protocol was
approved by the Research Ethics Com-
mittee of the Hospital District of
Northern Savo, Kuopio, Finland (No.
40/2010), and the study was conducted
in accordance with the principles pre-
sented in the Declaration of Helsinki.
After providing verbal and written
information about the study, written
consent was obtained from all partici-
pants. The data were collected prospec- Fig. 5. Flow-chart.

24
Acta Ophthalmologica 2016

overall health status is now (1) much tests used were t-tests of the paired The improvement of HRQoL after
better, (2) slightly better, (3) much the samples to compare pre- and postop- cataract surgery was slight. In subjects
same, (4) slightly worse, (5) much erative data, chi-squared test to com- with both the baseline and postopera-
worse. Based on that data, a generic pare proportions and t-tests of tive data (n = 152), the 15D score
minimally important change (slightly independent samples were used to improved from a mean of 0.837
better/worse) of 0.015 of 15D scored compare the data with an age- and (0.093) to 0.855 (0.097) with a mean
was found (Alanne et al. 2015). gender-standardized sample. Data are difference of 0.018 [95% CI: 0.007,
The improvement of HRQoL was presented as number of cases (%), 0.029, p = 0.002 (t-test of paired sam-
assumed to last till the end of life, and mean (SD) and mean difference (95% ples)] at 12 months after the first-eye
quality-adjusted life years (QALY’s) confidence interval for the difference) cataract surgery. This change was also
were calculated by multiplying the as appropriate. A p-value of <0.05 was clinically important. The postoperative
utility index (e.g. the HRQoL score considered to be statistically signifi- HRQoL was much better (>0.035) in
between 0 and 1) by the remaining cant. 64 (42%) subjects, slightly better
statistical life expectancy of each sub- (0.015–0.035) in 12 (8%) subjects and
ject based on the Life Tables 2012 from much the same in 30 (20%) subjects.
7.4. Results
the Official Statistics of Finland (2014). The postoperative HRQoL at
A discount rate of 5% was used in the Data at baseline were available for 182 12 months was slightly worse ( 0.035
QALY calculation (Busbee et al. 2002; (93%) subjects, mean age 73 years (SD to 0.015) in 16 (11%) subjects and
R€as€anen et al. 2006). 9.6), 65% females and at 12 months much worse (less than 0.035) in 30
We compared the HRQoL of the after surgery for 152 (84%) subjects (20%) subjects. The 15D instrument
study subjects with that of an age- and with a mean age 74 years (9.7) and showed significant improvement on five
gender-standardized representative 66% female. During the 12-month dimensions as follows: moving, seeing,
sample of the general population from follow-up, 100 of the 152 subjects hearing, usual activities and discom-
the Health 2011 survey. The data were (66%) also had cataract surgery in the fort/symptoms (Fig. 6).
collected by the National Institute for second eye. Of the 152 patients, 30 For subjects with only the first eye
Health and Welfare (THL) in 2011 (20%) had ocular comorbidities at operated during the 12-month follow-
using self-administered questionnaires, baseline; 15 (10%) patients had glau- up [n = 52 (34%)], the mean 15D score
including the 15D questionnaire, per- coma, 4 (3%) had diabetic retinopathy was clinically and statistically signifi-
sonal interviews and clinical examina- or maculopathy, and 11 (7%) had cantly higher at 12 months [0.858
tions (Koskinen et al. 2012). For the other ocular diseases. The best-cor- (0.112)] compared with the baseline
comparison those individuals were rected visual acuity at baseline is pre- [0.828 (0.103), p = 0.003]. The postop-
selected, who were in the age range of sented at Table 6. erative HRQoL was much better in 25
the patients (n = 4307), and this sample No prior sample size calculation was (48%) subjects, slightly better in 5
was weighted to reflect the age and performed, but a two-sided post hoc (10%) and much the same in 10
gender distribution of the patients. power analysis indicated that the study (19%) subjects. The postoperative
had a power of 0.86 to show an HRQoL at 12 months was slightly
improvement of at least of 0.015 in worse in 6 (12%) subjects and much
7.3. Statistics
the mean 15D score at 12 months after worse in 6 (12%) subjects, respectively.
The data were entered into SPSS sta- surgery compared to that before sur- For subjects with an operation in
tistical software (IBM SPSS Statistics gery at a desired significance level of their second eye during the 12-month
19; Armonk, NY, USA). The statistical 0.05. follow-up period [n = 100 (66%)], the

Table 6. The best-corrected visual acuity at baseline and change in the 15D score.

Change in 15D score (n)

Much better Slightly better Much the same Slightly worse Much worse
Visual acuity* (>0.035) (0.015 to 0.035) (0.015 to 0.015) ( 0.015 to 0.035) (< 0.035) Total (n)
**
Worse eye
≤0.10 7 2 – – 4 13
0.125–0.25 10 1 7 6 6 30
0.30–0.63 43 8 20 9 20 100
≥0.80 3 – 2 1 – 6
Total 63 11 29 16 30 149
Better eye***
≤0.10 2 – – – – 2
0.125–0.25 2 2 1 – 3 8
0.30–0.63 46 7 22 12 22 109
≥0.80 13 2 7 4 5 31
Total 63 11 30 16 30 150

Data are number of cases.


*Best-corrected visual acuity (Snellen equivalents); **p = 0.373; ***p = 0.644, chi-squared test.

25
Acta Ophthalmologica 2016

Fig. 6. The comparison of cataract patients and control population in the 15 dimensions of 15D Instrument: Move = moving, See = Seeing,
Hear = Hearing, Breath = breathing, Sleep = sleeping, Eat = eating, Speech = speech, Excret = eliminating, Uact = usual activities, Mental = men-
tal function, Disco = discomfort and symptoms, Depr = depression, Distr = distress, Vital = vitality and sex = sexual activity, Popul = Age- and
gender-matched control population.

mean 15D score was similar at baseline remained slightly lower in the cataract likely to decrease the bias associated
[0.842 (0.088)] and at 12 months [0.853 group than in the control population with the use of historical controls
(0.087), p = 0.118]. The postoperative with a mean difference of 0.019 (95% (Koskinen et al. 2012). However,
HRQoL was much better in 38 (38%) CI: 0.002, 0.037, p = 0.029). The dif- beyond the improvement of vision-
subjects, slightly better in 7 (7%) sub- ference was still clinically important. related difficulties after surgery in
jects and much the same in 20 (20%) At 12 months, four dimensions, see- cataract subjects, previously reported
subjects. The postoperative HRQoL at ing, breathing, excretion and vitality, difficulties in moving, usual activities,
12 months was slightly worse in 10 were lower in cataract subjects than in discomfort and symptoms, and distress
(10%) subjects and much worse in 25 the control population (p < 0.05; had improved and were similar to the
(25%) subjects, respectively. Fig. 6). control population at 12 months after
The mean QALY gain in the whole surgery.
study population was modest. A mean When compared our results to a
7.5. Discussion
life expectancy of 13.9 remaining years sample collected from a rural area of
in the whole study population, multi- Our data indicate that people with Finland and 10 years earlier, the study
plied by the net utility gain, resulted in cataract have low HRQoL, not only subjects reported much better HRQoL
0.14 (95% CI: 0.03, 0.25) discounted on seeing but also on several other (a mean 15D score of 0.84) than those
QALYs gained by cataract surgery. dimensions. In the present study, we who were on a waiting list for cataract
For subjects with only the first eye have shown a mean improvement of surgery 10 years ago (a mean 15D
operated, the mean QALY gain was the HRQoL after cataract surgery as score of 0.79). In that study, the
0.27 (95% CI: 0.10, 0.45) compared measured by a generic instrument, the quality of life of patients waiting for
with 0.068 (95% CI: 0.06, 0.20) for 15D. Five of the fifteen dimensions cataract surgery was equal to the
subjects with an operation in their improved significantly, that is after population-based sample. 15D scores
second eye during the 12 months fol- cataract surgery with a phacoemulsifi- indicated better HRQoL in those
low-up. cation technique, subjects reported patients with less cataract and better
When compared with the age- and fewer problems with seeing and also visual acuity (Falck et al. 2008). Our
gender-standardized sample of the with moving, hearing, usual activities study indicates no significant differ-
general population, cataract subjects and discomfort/symptoms than at ences in the improvement of HRQoL
had much worse HRQoL at baseline baseline before surgery. However, in in between patients with different
with a mean difference of 0.037 (95% general, the gain was modest. visual acuity measured at baseline.
CI: 0.020, 0.054), p < 0.001 (t-test of In our comparison of cataract sub- There are two likely reasons for the
independent samples). The difference jects with an age- and gender-standar- reported difference in the HRQoL
was clinically important. At baseline, dized control population, the overall between the two studies. The differ-
cataract subjects reported significantly HRQoL score was worse both at ence could be related to the better
more difficulties on nine out of the 15 baseline and at 12 months after sur- visual acuity on the study subjects
dimensions as follows: moving, seeing, gery in cataract subjects. Before sur- compared to those in the Falck et al.
hearing, breathing, excretion, usual gery, cataract subjects reported more (2008) study. Moreover, the perception
activities, discomfort and symptoms, difficulties on nine out of fifteen of life among Finns has improved
distress and vitality (p < 0.05). At dimensions. As the population 15D during the last decade, and this may
12 months after surgery, five dimen- data were collected at the same time as be the case also among people with
sions had improved, but the HRQoL those of the cataract subjects, this is cataract (Koskinen et al. 2012).

26
Acta Ophthalmologica 2016

When evaluated with disease-specific significantly higher mean gain of 1.6 baseline visual function after the first-
outcome measures, cataract surgery is QALYs after cataract surgery based on eye cataract surgery (Sach et al. 2010).
highly effective and considered to be hypothetical time trade-off (TTO) However, due to methodological dif-
one of the most cost-effective surgical vision utilities. Therefore, these gains ferences, these results may not be
procedures (Busbee et al. 2002; Riaz are not comparable. The usage of comparable.
et al. 2006; Brown et al. 2013). How- generic instruments is necessary to The previous literature has shown
ever, analyses using generic HRQoL compare procedures from different that the reliability and repeatability of
instruments have yielded inconsistent medical specialties, as disease-specific the 15D Instrument are good (Sintonen
results. R€as€anen et al. (2006) used the instruments may overestimate the gain 1994; Stavem 1999). However, previous
15D instrument and reported an of QALYs. literature has also shown limitations in
insignificant improvement in the mean There are some limitations in the the usage of patient-reported outcome
15D score, as only seeing of the 15 present study. Our sample size was measurements of HRQoL in the area
dimensions of the HRQoL instrument relatively small as we had pre- and of cataract surgery and other sensory-
improved compared with baseline. postoperative data on 152 subjects. We related interventions (Kobelt et al.
Using the same generic instrument, assess 303 patients for eligibility but 59 2006; Sach et al. 2010). The utility
15D, we found slightly more improve- (19%) decline to participate, 92 (30%) scores may be driven more by the
ment in the mean 15D score at were excluded because surgery was function of the better-seeing eye rather
12 months with 0.018 in the present cancelled or delayed, or because the than its poorer counterpart (Kobelt
study versus 0.010 at 6 months after patients were lost to follow-up. This et al. 2006).
cataract surgery as found in the may have caused a selection bias on In conclusion, cataract subjects had
R€as€anen et al. (2006) study. the study population. However, with a low HRQoL on several dimensions
Another generic instrument, the EQ- this sample size the study had a two- measured with a generic instrument.
5D questionnaire (EuroQoL Group sided power of 0.86 to detect an Our data indicate that cataract surgery
1990), was used in the Danquah et al. improvement of 0.015 on 15D score, improves the HRQoL at 12 months
(2014) study that reported a significant and thus, the sample size could be after a first-eye cataract surgery, but
improvement in most of the five considered sufficient. Moreover, we did the postoperative HRQoL may remain
domains at 12 months after cataract not collect postoperative data either on lower than that of an age- and gender-
surgery. At baseline, the self-rated visual acuity or ophthalmic status in standardized control population. At
health score in cataract subjects was our study procedure, both of whom 12 months after cataract surgery, see-
worse than that in age- and gender- might have provided further interesting ing improved significantly, and the
matched controls without seeing diffi- information concerning the HRQoL. preoperatively reported difficulties in
culties, but after surgery, the self-rated Other ocular conditions such as dia- moving, usual activities, discomfort
health score of cataract subjects was betic retinopathy and presbyopia have and symptoms, and distress reached
reported to be similar to the controls, been reported also to have a negative the levels of the control population.
as were most of the five dimensions of impact on HRQoL (Goertz et al. 2014;
the EQ-5D. Unfortunately, Danquah Hannula et al. 2014). However, only
7.6. Acknowledgements
et al. (2014) did not report the overall few patients in our study sample suf-
EQ-5D score in their paper. fered from severe macular degenera- There was no conflict of interests that
In a study by Steinberg et al. tion or diabetic retinopathy. During could be perceived as prejudicing the
(1994a), 67% of patients showed a the follow-up of 12 months, an YAG- impartiality of the research reported.
significant gain in HRQoL measured capsulotomy was made for four No external sources of funding were
with a generic instrument, the Sick- patients, and two patients having age- used to prepare this manuscript.
ness Impact Profile (de Bruin et al. related macular degeneration were
1994), at 4 months after cataract treated with intraocular VEGF-inhibi-
surgery. The visual acuity and visual tor therapy. We enrolled patients hav- 7.7 References
functioning improved in 96% and ing first-eye surgery, but we also
89% of patients measured with the included subjects with the second eye Alanne S, Roine RP, R€as€anen P, Vainiola T &
Visual Functioning Index VF-14 operated during the follow-up period Sintonen H (2015): Estimating the minimum
(Steinberg et al. 1994b), respectively. in the analysis. The HRQoL improve- important change in the 15D scores. Qual
Life Res 24: 599–606.
Our findings, based on measurements ment was more significant in subjects
Brown GC, Brown MM, Menezes A, Busbee
with the disease-specific visual func- with only the first-eye surgery per- BG, Lieske HB & Lieske PA (2013):
tioning questionnaires Catquest-9SF formed. This finding was not expected, Cataract surgery cost utility revisited in
(Lundstr€ om & Pesudovs 2009) and because second-eye surgery has been 2012: a new economic paradigm. Ophthal-
Visual Functioning Index VF-7 (Uusi- previously shown to further improve mology 120: 2367–2376.
talo et al. 1999), have shown a similar the HRQoL in cataract patients based de Bruin AF, Diederiks JP, de Witte LP,
significant gain in visual functioning on hypothetical TTO vision utilities Stevens FC & Philipsen H (1994): The
and vision-specific HRQoL after cat- (Brown et al. 2013). However, the development of a short generic version of
the Sickness Impact Profile. J Clin Epi-
aract surgery (Porela-Tiihonen et al. previous studies have found that the
demiol 7: 407–418.
2014). second-eye surgery may be less cost- Busbee BG, Brown MM, Brown GC &
In our study population, the QALY effective and provides less improve- Sharma S (2002): Incremental cost-effective-
gain was modest, 0.14. A recent report ment compared with the first-eye sur- ness of initial cataract surgery. Ophthalmol-
by Brown et al. (2013) reported a gery, which may be related to a good ogy 109: 606–612; discussion 612–613.

27
Acta Ophthalmologica 2016

Damiano AM, Steinberg EP, Cassard SD Porela-Tiihonen S, Kaarniranta K, Kokki M


et al. (1995): Comparison of generic versus & Kokki H (2015): Recovery and patient
8. General discussion
disease-specific measures of functional satisfaction after cataract surgery. A one-
impairment in patients with cataract. Med year prospective follow-up study. Acta Oph- 8.1. Summary
Care 33: AS120–AS130. thalmol 93: e172–173.
Postoperative ocular surface irritation
Danquah L, Kuper H, Eusebio C, Rashid MA, Ramsey S, Willke R, Briggs A et al. (2005):
Bowen L, Foster A & Polack S (2014): The Good research practices for cost-effective-
may result from both the surgical
long term impact of cataract surgery on ness analysis alongside clinical trials: the trauma and the topical ocular drug
quality of life, activities and poverty: results ISPOR RCT-CEA Task Force report. Value therapy used as a part of perioperative
from a six year longitudinal study in Health 8: 521–533. Review. and postoperative care. The present
Bangladesh and the Philippines. PLoS R€as€anen P, Krootila K, Sintonen H, Leivo T, literature search revealed a wide range
ONE 9: e94140. doi: 10.1371/journal.pone. Koivisto AM, Ryyn€anen OP, Blom M & in the occurrence of postoperative pain
0094140. eCollection 2014. Roine RP (2006): Cost-utility of routine and painful ocular symptoms after
EuroQol Group (1990): EuroQol–a new facil- cataract surgery. Health Qual Life Out-
cataract surgery (Publication I). The
ity for the measurement of health-related comes 4: 74.
quality of life. Health Policy 16: 199–208. Riaz Y, Mehta JS, Wormald R, Evans JR,
present study indicates that postopera-
Falck A, Kuoppala J, Winblad I & Tuulonen Foster A, Ravilla T & Snellingen T (2006): tive pain was relatively common during
A (2008): The Pyh€ aj€arvi Cataract Study. I. Surgical interventions for age-related catar- the first hours after cataract surgery;
Study design, baseline characteristics and act. Cochrane Database Syst Rev (4): one out of three patients reported some
the demand for cataract surgery. Acta Oph- CD001323. Review. pain and one out of every ten patients
thalmol 86: 648–654. Sach TH, Foss AJ, Gregson RM, Zaman A, experienced moderate to severe pain
Goertz AD, Stewart WC, Burns WR, Stewart Osborn F, Masud T & Harwood RH (2010): after surgery (Publication II). The
JA & Nelson LA (2014): Review of the Second-eye cataract surgery in elderly
presence of postoperative ocular symp-
impact of presbyopia on quality of life in the women: a cost-utility analysis conducted
developing and developed world. Acta Oph- alongside a randomized controlled trial.
toms was related to lower patient
thalmol 92: 497–500. Eye (Lond) 24: 276–283. satisfaction at 12 months after the
Gold MR, Siegel JE, Russell LB & Weinstein Sintonen H (1994). The 15D-measure of first-eye cataract surgery. Thus, the
MC (eds). (1996): Cost-Effectiveness in health-related quality of life. I. Reliability, patients should be provided with
Health and Medicine. New York: Oxford validity and sensitivity of its health state instructions for pain management and
University Press. descriptive system, Working Paper 41. Mel- contact information; in case, they
Hannula V, Hautala N, Sintonen H & Falck A bourne: National Centre for Health Pro- should experience significant postoper-
(2014): Health-related quality of life–using gram Evaluation. Available at: http://www.
ative ocular pain. Itchiness, burning
the 15D instrument–of young adults with buseco.monash.edu.au/centres/che/pubs/wp41.
type 1 diabetes since childhood. Population- pdf. (Accessed on 15 May 2014).
sensation and foreign body sensation
based Oulu cohort study of diabetic Sintonen H (1995): The 15-D measure of were the most common symptoms
retinopathy. Acta Ophthalmol 92: 205–208. health-related quality of life. II. Feasibility, reported after surgery (Publication II).
Kobelt G, Jonsson B, Bergstr€ om A, Chen E, reliability and validity of its valuation sys- These symptoms are also considered to
Linden C & Alm A (2006): Cost-effective- tem, Working Paper 42. Melbourne: be manifestations of ocular surface
ness analysis in glaucoma: what drives National Centre for Health Program Eval- disease (Dry Eye WorkShop 2007),
utility? Results from a pilot study in Sweden. uation. Available at: http://www.buseco. and some patients may benefit from
Acta Ophthalmol Scand 84: 363–371. monash.edu.au/centres/che/pubs/wp42.pdf.
tear substitutes as a way to improve
Koskinen S, Lundqvist A & Ristiluoma N (Accessed on 16 June 2014).
(eds) (2012): Health, functional capacity and Sintonen H (2001): The 15D instrument of
postoperative ocular comfort and
welfare in Finland in 2011, Report 68/2012. health-related quality of life: properties and enhance patient satisfaction after cat-
Helsinki: National Institute for Health and applications. Ann Med 33: 328–336. aract surgery. Some of the symptoms
Welfare (THL). Stavem K (1999): Reliability, validity and such as burning and foreign body
Lundstr€ om M & Pesudovs K (2009): Catquest- responsiveness of two multiattribute utility sensation are also difficult to distin-
9SF patient outcomes questionnaire: nine- measures in patients with chronic obstruc- guish from ocular pain.
item short-form Rasch-scaled revision of the tive pulmonary disease. Qual Life Res 8: 45– The present study indicates that
Catquest questionnaire. J Cataract Refract 54.
patients who report postoperative ocu-
Surg 35: 504–513. Steinberg EP, Tielsch JM, Schein OD et al.
McAlinden C, Gothwal VK, Khadka J, (1994a): National study of cataract surgery
lar discomfort are less satisfied with
Wright TA, Lamoureux EL & Pesudovs K outcomes. Variation in 4-month postopera- their treatment outcome (Publication
(2011): A head-to-head comparison of 16 tive outcomes as reflected in multiple out- III). There do not appear to be any
cataract surgery outcome questionnaires. come measures. Ophthalmology 101: 1131– previous studies which have evaluated
Ophthalmology 118: 2374–2381. 1140; discussion 1140–1141. the relationship between postoperative
Nord E, Daniels N & Kamlet M (2009): Steinberg EP, Tielsch JM, Schein OD et al. symptoms and patient satisfaction after
QALYs: some challenges. Value Health 12 (1994b): The VF-14. An index of functional cataract surgery. Here, 85% of patients
(Suppl. 1): S10–S15. impairment in patients with cataract. Arch
were satisfied with the treatment out-
Official Statistics of Finland (OSF) (2014): Ophthalmol 112: 630–638.
Deaths [e-publication]. ISSN=1798-2545. Hel- Uusitalo RJ, Brans T, Pessi T & Tarkkanen A
come, which is similar to previous
sinki: Statistics Finland. Available at: http:// (1999): Evaluating cataract surgery gains by findings (61–91%; Steinberg et al.
www.stat.fi/til/kuol/index_en.html. (Accessed assessing patients’ quality of life using the 1994a,b; Schein et al. 1995; Tielsch
on 14 Aug 2014). VF-7. J Cataract Refract Surg 25: 989–994. et al. 1995; Uusitalo & Tarkkanen
Porela-Tiihonen S, Kaarniranta K, Kokki M, Wisløff T, Hagen G, Hamidi V, Movik E, 1998; Nijkamp et al. 2000; Mamidi-
Purhonen S & Kokki H (2013): A prospec- Klemp M & Olsen JA (2014): Estimating pudi et al. 2003; Garcia-Gutierrez
tive study on postoperative pain after QALY gains in applied studies: a review of et al. 2014). No correlation was
cataract surgery. Clin Ophthalmol 7: 1429– cost-utility analyses published in 2010. Phar-
detected between increasing age or
1435. macoeconomics 32: 367–375.
ocular comorbidity and satisfaction

28
Acta Ophthalmologica 2016

with treatment outcome or satisfaction text and doing fine handwork. The declined to participate or were not able
with life in general. Of the 24 patients numbers of patients eligible to analyse to participate due health-related con-
reporting dissatisfaction with the treat- the level of disability, using the Wil- ditions. However, this is a common
ment outcome, ten also expressed feel- coxon signed-rank test, were too small problem in studies performed with
ings of distress and dissatisfaction in most questions, which may be the elderly people (Provencher et al.
related to other health issues. Those reason for the statistically non-signifi- 2014). Some of the study questions
patients who underwent cataract sur- cant improvement in these items. may also not have been fully under-
gery in the second eye within the 12- The cataract patients reported some stood by all of the subjects, as some of
month follow-up period were more difficulties in several dimensions mea- their answers were inconsistent. Five
satisfied compared to patients with sured with a 15-dimensional generic patients died during the 1-year follow-
the first-eye surgery only, similar to HRQoL instrument, the 15D (Publica- up. Moreover, most of the outcome
the findings of R€ onbeck et al. (2011). tion IV). The data indicate that cataract measurements were assessed subjec-
Patients who underwent additional surgery improves the HRQoL at tively by the patients, and the subjects
ocular surgical procedures during the 12 months after first-eye cataract sur- had no follow-up visits that could have
12-month follow-up period were less gery, but the postoperative HRQoL provided some objective data on VA,
satisfied with the cataract surgery out- may still remain lower than that of an for example.
come. This was expected and is in age- and gender-standardized control The patients with severe intraopera-
agreement with two previous studies in population. Five of the fifteen dimen- tive complications were excluded, as the
which the presence of ocular complica- sions of the 15D instrument improved aim was to study the results of routine,
tions after cataract extraction surgery after cataract surgery, as fewer difficul- uncomplicated cataract surgery. The
was related to lower satisfaction with ties were reported with seeing, moving, inclusion of these patients might have
the outcome (Schein et al. 1995; Gar- hearing, usual activities and discom- provided further information. As the
cia-Gutierrez et al. 2014). fort/symptoms at 12 months after sur- study was performed in an educational
Patients with less VF impairment at gery than had been present at baseline. university hospital, eight different sur-
baseline were more satisfied with the However, in general, the gain was geons with different histories of surgical
outcome thus supporting the benefits of modest. When compared to an age- and educational experience performed
early surgical intervention in patients and gender-standardized control popu- the surgeries. Moreover, the patients’
with cataract (Publication III). Several lation at 12 months after cataract sur- satisfaction with the treatment outcome
previous studies have presented a posi- gery, the dimension of seeing had is assumed to be affected of the surgeon’s
tive correlation between better postop- improved significantly, and the preop- communication with the patient.
erative VF and greater patient eratively reported difficulties in moving, The previous literature has also
satisfaction after cataract surgery usual activities, discomfort and symp- shown limitations in the usage of
(Steinberg et al. 1994a,b; Lundstr€ om toms, and distress reached the level of patient-reported outcome measure-
et al. 1997; Uusitalo & Tarkkanen the control population. ments of HRQoL in the area of cataract
1998; Uusitalo et al. 1999; Friedman surgery and other sensory-related inter-
et al. 2002; Mamidipudi et al. 2003; ventions (Kobelt et al. 2006; Sach et al.
8.2. Limitations of the present study
Lundstr€ om & Stenevi 2013). In the 2010). The utility scores may be driven
present study, patients who reported There were some limitations in the more by the function of the better-seeing
greater preoperative difficulties in the study design, as it was a prospective eye rather than its poorer counterpart
Catquest questionnaire reported less observational longitudinal clinical (Brown 2000; Kobelt et al. 2006). In
satisfaction with the postsurgical out- study. The sample size was relatively unilateral cataract surgery, the good VA
come. This agrees with the results from small as the study patients were col- in the better-seeing eye may result in less
Garcia-Gutierrez et al. (2014) who used lected over a limited time period, and gain in HRQoL despite the improved
the VF-14 as a VF measurement but the follow-up time was also relatively vision in the operated eye (Kobelt et al.
contradict the results reported by short, 12 months. Moreover, as the 2006). Furthermore, it is possible that
R€onbeck et al. (2011) in which patients observation period was pre-deter- the patients may also have adapted to
with lower preoperative best-corrected mined, two-thirds of the subjects had the disabilities they have (Sach et al.
VA reported greater postoperative sat- a second eye operated before the last 2010).
isfaction. In the studies of Uusitalo et al. questionnaire. Thus, there was com-
(1999), Mamidipudi et al. (2003) and plete data only for 52 patients with a
8.3. Future directions
Garcia-Gutierrez et al. (2014), the single eye operated. The same patients
change in the VF score was a strong filled in all the study questionnaires To elucidate more the value of the
predictor of the change in the patients’ that may have affected the answers. It treatment of different diseases and
satisfaction with their vision. is possible that over a time respondents performing different procedures includ-
The improvement in VF measured may have unknowingly changed their ing cataract surgery, more data of
with the Catquest, and the VF-7 was as qualitative responses to better fit what HRQoL should be collected with gen-
good as expected (Publication III). they consider to be the observer’s eric instruments. Guidelines of safe and
When this improvement was analysed intended goal. Moreover, the presence effective pain treatments after cataract
with respect to the level of visual of outliers in such a small cohort can surgery are needed. As the symptoms
disability after surgery in VF-7-index, exert a major influence on the results of ocular irritation resemble those of
only two items achieved statistical (Kobelt et al. 2006). Approximately dry eye syndrome, the efficacy of ocular
significance (p < 0.05): reading small one-fifth of the recruited 303 patients lubricant therapy should be evaluated

29
Acta Ophthalmologica 2016

in studies with a sufficient sample size leikkauksen j€ alkeist€a toipumista on kuivasilm€ aisyyden oireita, ja osa poti-
and prospective follow-up. tutkittu vain v€ ah€an. T€ am€an tutkimuk- laista hy€ otyisi mahdollisesti kuiv-
Future studies with larger sample sen tavoitteena on selvitt€ a€
a kai- asilm€ aisyyden hoitoon k€ aytett€
avist€
a
sizes will be needed to evaluate the hileikkauksen j€ alkeisen silm€ akivun ja paikallisvalmisteista.
management of postoperative pain and silm€an €arsytysoireiden esiintyvyytt€ a, Tutkimuksessa osoitettiin silm€ aoire-
other painful ocular irritation symp- voimakkuutta ja kestoa. Tutkimuksen ita ilmoittavien potilaiden olevan
toms with analgesic drug therapy after toisena tavoitteena on selvitt€ a€a poti- merkitt€ av€
asti tyytym€att€om€ampi€a
cataract surgery. A conclusion emerg- laiden leikkauksen j€ alkeiseen tyy- leikkaustulokseen vuosi leikkauksen
ing from this study was that postoper- tyv€aisyyteen vaikuttavia tekij€ oit€
a, ja alkeen (p = 0.001). Potilaiden ennen
j€
ative ocular pain and other painful kaihileikkauksen vaikutusta potilaiden leikkausta ilmoittama parempi
ocular symptoms after cataract surgery terveyteen liittyv€ a€an el€ am€ anlaatuun p€aivitt€
ainen n€ ak€okyky oli yhteydess€ a
do affect the patients’ experience of sek€a p€aivitt€aiseen el€ am€ a€
an liittyv€ a€
an my€ os parempaan tyytyv€ aisyyteen vuosi
care and satisfaction with the treatment n€ak€okykyyn. leikkauksen j€ alkeen. Terveyteen liittyv€a
and the treatment outcome. Thus, all Tutkimus oli seurantatutkimus, jossa el€
am€ anlaatu parani merkitt€av€asti
patients should be provided with suffi- toipumista ja silm€ aoireita mitattiin (p = 0.002) 15D-mittarilla mitattuna.
cient counselling about the possible kyselyll€a 1 p€aiv€a, 1 viikko, 6 viikkoa ja I€ a€
alt€ an ja sukupuoleltaan vastaavaan
symptoms they may experience after 1 vuosi leikkauksen j€ alkeen. Kai- verrokkiv€ aest€ €n verrattuna kaihipoti-
oo
surgery as one way to improve patient hileikkauksen vaikutusta p€ aivitt€
aiseen laiden terveyteen liittyv€ a el€am€anlaatu
satisfaction and the quality of life after n€ak€okykyyn liittyv€ a€
an haittaan mitat- oli huonompi sek€ a ennen leikkausta
cataract surgery. tiin Visual Functioning Index VF-7 ja ett€
a vuosi leikkauksen j€ alkeen.
Catquest-9SF-mittarein ennen leik-
kausta ja vuosi leikkauksen j€ alkeen.
9. Conclusions Terveyteen liittyv€ a€a el€ am€ anlaatua
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