CD 002221

Interventions for involutional lower lid entropion (Review)
Boboridis KG, Bunce C
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2011, Issue 12
http://www.thecochranelibrary.com

Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
PLAIN LANGUAGE SUMMARY .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
RESULTS . . . . . . . . . .
Figure 1.
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Figure 2.
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DISCUSSION . . . . . . . .
AUTHORS CONCLUSIONS . .
ACKNOWLEDGEMENTS
. . .
REFERENCES . . . . . . . .
CHARACTERISTICS OF STUDIES
DATA AND ANALYSES . . . . .
APPENDICES . . . . . . . .
WHATS NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
INDEX TERMS
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[Intervention Review]
Interventions for involutional lower lid entropion

Kostas G Boboridis1 , Catey Bunce2
1 Aristotle
University of Thessaloniki, 54622 Thessaloniki, Greece. 2 Research and Development Department, Moorfields Eye Hospital
NHS Foundation Trust, London, UK
Contact address: Kostas G Boboridis, Aristotle University of Thessaloniki, Pavlou Mela 16, 54622 Thessaloniki, Greece.
kosbob@otenet.gr.
Editorial group: Cochrane Eyes and Vision Group.
Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 12, 2011.
Review content assessed as up-to-date: 2 November 2011.
Citation: Boboridis KG, Bunce C. Interventions for involutional lower lid entropion. Cochrane Database of Systematic Reviews 2011,
Issue 12. Art. No.: CD002221. DOI: 10.1002/14651858.CD002221.pub2.
ABSTRACT
Background
Entropion is a condition in which the eyelid margin turns in against the eyeball. Involutional or senile entropion is one of the most
common lower lid malpositions in the elderly. The interventions described and currently used for the treatment of this condition are
surgical in nature, although non-surgical temporary medical treatment for the early stages of entropion has also been reported. The
relative effectiveness of these interventions has not yet been resolved.
Objectives
To examine the effect of interventions for involutional entropion and to assess whether any method is superior to any other.
Search methods
We searched CENTRAL (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2011, Issue 10),
MEDLINE (January 1950 to November 2011), EMBASE (January 1980 to November 2011), the metaRegister of Controlled Trials
(mRCT) (www.controlled-trials.com),ClinicalTrials.gov (http://clinicaltrials.gov) and the WHO International Clinical Trials Registry
Platform (ICTRP) (www.who.int/ictrp/search/en). There were no date or language restrictions in the electronic searches for trials. The
electronic databases were last searched on 2 November 2011. We also searched oculoplastic textbooks, conference proceedings from the
European and American Society of Ophthalmic Plastic and Reconstructive Surgery (ESOPRS, ASOPRS), European Ophthalmological
Society (SOE), the Association for Recearch in Vision and Ophthalmology (ARVO) and American Academy of Ophthalmology (AAO)
for the years 2000 to 2009 to identify relevant data. We attempted to contact researchers who are active in this field for information
about further published or unpublished studies.
Selection criteria
We included randomised controlled trials (RCTs) with no restriction on date or language comparing two or more surgical methods for
correction of involutional lower eyelid entropion in people older than 60 years of age with involutional lower lid entropion.
Data collection and analysis
Each review author independently assessed study abstracts identified from the electronic and manual searches. Author analysis was then
compared and full papers for appropriate studies were obtained according to the inclusion criteria. Disagreements between the authors
were resolved by discussion.
Main results
We identified one RCT which met our inclusion criteria and was included in this review. Sixty-three participants with primary
involutional lower eyelid entropion were randomised to everting sutures alone or everting sutures with a lateral tarsal strip. Eight
participants were lost to follow-up. The trial indicates that the combined procedure for horizontal and vertical eyelid tightening in the
form of everting sutures and lateral tarsal strip is highly curative for involutional entropion compared to vertical tightening in the form
of everting sutures alone. The superiority of the combined approach is also supported by many good quality uncontrolled studies on
specific surgical procedures but these were not included in the analysis as they were not part of the inclusion criteria.
Authors conclusions
A single RCT showed that the combination of horizontal and vertical eyelid tightening with everting sutures and lateral tarsal strip is
highly efficient for entropion compared to vertical tightening with everting sutures alone. Retrospective case series studies also support
the combined surgical repair but details from these studies on specific surgical techniques cannot be included in the analysis.
Evidence from a single RCT is unlikely to change clinical practice and thus it is still our view that there is a clear need for more
randomised studies comparing two or more surgical techniques for entropion surgery addressing the recurrence and complications rate.
PLAIN LANGUAGE SUMMARY

Interventions for treating an inward turning lower eyelid in the elderly
Entropion is the inward turning of the eyelid, causing rubbing of the eyelashes and eyelid skin against the surface of the eye. It is one
of the commonest forms of eyelid problems in older people and it more frequently involves the lower eyelid. In the early stages not
all people require treatment but eventually every movement of the eye or eyelid causes trauma to the corneal surface which may lead
to infection and ulceration with visual impairment. Surgery in the form of horizontal and vertical eyelid tightening is needed when
the condition is severe and causes trauma to the cornea. The review authors searched the medical literature and found a single trial
that met the inclusion criteria of the review. Sixty-three participants with lower eyelid entropion were enrolled and randomised to
either everting sutures alone or everting sutures and a lateral tarsal strip. Eight participants were lost to follow-up. The trial showed
that the combination of horizontal and vertical eyelid tightening with everting sutures and lateral tarsal strip is highly efficient for
entropion compared to vertical tightening with everting sutures alone. Further research is needed to provide more credible evidence
for the comparison of surgical treatments to correct an inward turning eyelid.
BACKGROUND
Description of the condition

Entropion is a condition in which the eyelid margin and eyelashes
turn in towards the eyeball. It is divided into four main types according to the cause: congenital, involutional, spastic and cicatricial. Involutional or senile entropion is one of the most common
lower lid malpositions in the elderly population and one of the
most common treated in clinical practice (Levine 1998; Pereira
2010).
The prevalence of involutional lower lid entropion has been reported to be 2.1% in the elderly population (1.9% in men and
2.4% in women) with no reported details for the frequency of its
surgical management (Damasceno 2011a). It is characterised by
constant rubbing of the eyelid margin, eyelashes and skin against

the ocular surface resulting in inflammation of the conjunctiva
and corneal abrasions. This can result in secondary corneal thinning, vascularisation and scarring. Corneal ulceration and perforation may occur in chronic cases (Musch 1983; Tse 1992). Patients
complain of a chronic foreign body sensation, redness, tearing and
discharge.
The main aetiological factors of this condition are progressive
senile changes in the following eyelid structures (Collin 1989;
Damasceno 2011b):
orbicularis muscle - changes allow the preseptal muscle to
roll upwards over the pretarsal muscle;
lower lid retractors - laxity of the retractors allows the lower
border of the tarsal plate to rotate outwards;

tarsal plate - loses its stiffness and inward buckling allows

the upper border to invert more than the lower;
horizontal laxity - changes in the orbicularis muscle, canthal
tendons and tarsus lead to horizontal laxity of the lower lid.
It has been suggested that the main causes for the inward turning
of the lid are increased tone of the preseptal orbicularis muscle
over the pretarsal part of the muscle; atrophy and shrinkage of the
tarsal plate; and disinsertion of the lower lid retractors (Bashour
2000).
This review will investigate the comparative effectiveness of various interventions for involutional lower lid entropion and will
summarise potential complications related to surgery.
OBJECTIVES
To review current published evidence for the effectiveness of surgical correction for involutional lower eyelid entropion and highlight information on possible complications
Description of the intervention

Several surgical procedures addressing one or more of the aetiological factors have been developed over the years. Jones 1972 reported that more than 80 procedures had been described, indicating that there was poor understanding of the disease process and
low success rate in the available treatment modalities.
In current clinical practice, surgery for vertical lid shortening with
or without horizontal shortening is considered the only long-term
treatment for entropion. Vertical lid laxity can be corrected by indirectly reattaching the lower lid retractors as described by Wies
1954, or by directly reattaching the retractors as described by
Jones 1963. Vertical shortening can be combined with horizontal
shortening in the form of wedge excision or lateral canthal sling
(Anderson 1979; Tenzel 1969). Horizontal tightening of the orbicularis muscle, which also stabilises the retractors, has been described as a method for entropion repair (Wheeler 1938).
Non-surgical temporary treatment includes medical symptomatic
support with antibiotic or lubricating ointment, taping the lid to
the cheek and chemical denervation of the orbicularis muscle with
botulinum toxin injections (Clarke 1988; Neetens 1987).
How the intervention might work

Surgical management of entropion involves focusing on the involutional anatomical changes of the lower eyelid which are the main
causative factors of the condition. Correction of horizontal and/
or vertical eyelid laxity with any available surgical technique will
stabilise the eyelid and prevent its inward turning and rubbing of
the eyeball (Hintschich 2008).
Why it is important to do this review

During the early stages of the disease there is only an intermittent
inward turning of the lid and mild symptoms. Medical treatment
may provide adequate comfort. With the progression of involutional changes the lid is constantly rubbing against the eyeball and
surgical intervention may be required. It is not generally agreed
when treatment should be given or which is the best surgical approach (Skorin 2003).
METHODS
Criteria for considering studies for this review
Types of studies
We included randomised controlled trials (RCTs) with no restriction on date or language that were identified by our search strategy.
In the absence of RCTs we discussed well documented findings of
non-randomised studies which were identified by the same search
methods or were included as a selective summary.
Types of participants
We considered trials in which participants were people older than
60 years of age with involutional lower lid entropion, as defined
by the investigator.
Types of interventions
We included studies that compared one intervention for involutional lower lid entropion with another intervention.
Surgical techniques were divided into four groups:
1. those that indirectly addressed vertical lid laxity (inferior
retractor dehiscence);
2. those that directly addressed vertical lid laxity;
3. those that directly addressed horizontal lid laxity;
4. combination of vertical and horizontal shortening.
We also included studies of botulinum toxin injection, medical
symptomatic support and taping the lid to the cheek.
Types of outcome measures

We divided the outcome measures into:
1. short-term (up to six months after intervention);
2. intermediate (six to 18 months);
3. long-term (more than 18 months).

1. recurrence;
2. adverse events and complications such as over-correction;
3. quality of life;
4. socioeconomic implications (cost of treatment, outpatient
visits, days off work).
Two authors independently screened the titles and abstracts obtained from the searches to determine which studies fulfilled the
eligibility criteria. We excluded reports that did not meet the inclusion criteria and obtained full-text copies of reports referring to
trials that possibly or definitely met the inclusion criteria. Two authors assessed the full-text copies and selected studies according to
the inclusion criteria. The selected trials were further assessed for
quality whereas excluded studies were listed in the Characteristics
of excluded studies and reasons for exclusion documented. We
resolved disagreements between the authors by discussion.
Search methods for identification of studies
Data extraction and management
Primary outcomes
1. successful surgery i.e. normal eye lid position at rest.

Secondary outcomes
Electronic searches
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 10, part of The Cochrane Library. www.thecochranelibrary.com (accessed 2 November 2011),
MEDLINE (January 1950 to November 2011), EMBASE (January 1980 to November 2011), the metaRegister of Controlled
Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (
http://clinicaltrials.gov) and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en).
There were no language or date restrictions in the search for trials.
The electronic databases were last searched on 2 November 2011.
See: Appendices for details of search strategies for CENTRAL
(Appendix 1), MEDLINE (Appendix 2), EMBASE (Appendix
3), mRCT (Appendix 4),ClinicalTrials.gov (Appendix 5) and the
ICTRP (Appendix 6) .
Searching other resources
We searched oculoplastic textbooks and bibliographies of relevant
reports to find further trials. We contacted investigators and experts in the field, members of the ESOPRS and EUGOGO for details of other published and unpublished studies. We also searched
conference proceedings from the European and American Society of Ophthalmic Plastic and Reconstructive Surgery (ESOPRS,
ASOPRS), European Ophthalmological Society (SOE), the Association for Recearch in Vision and Ophthalmology (ARVO) and
American Academy of Ophthalmology (AAO) for the years 2000
to 2009 to identify relevant data.
For each identified RCT we included in the review, we manually
searched the reference lists of the trials cited for additional information.
Two authors independently extracted the following information

from the identified trials and entered it in to Review Manager
(RevMan 2011):
Methods: inclusion and exclusion criteria, method of allocation,
and other aspects of study design.
Details of participants: age, gender, setting, number in each group,
comparability at baseline.
Details of interventions: technique, stage of the disease, comparison group.
Outcomes: primary and secondary outcomes, adverse effects.
Other information: funding.
Assessment of risk of bias in included studies

Two authors independently assessed the included studies for
sources of systematic bias according to the guidelines in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We resolved disagreements by discussion.
We considered the following domains for risk of bias and assessed
each one as low risk of bias), high risk of bias and unclear.
Sequence generation: looking at the method of
randomisation in the allocation of the participants.
Allocation concealment.
Masking (blinding) of physicians and participants.
Incomplete outcome data: the completeness of outcome
data for outcomes will be reported, including attrition and
exclusions from analysis.
Selective outcome reporting.
Measures of treatment effect
Data collection and analysis
We sought guidance from Chapter 9 of the Cochrane Handbook

for Systematic Reviews of Interventions (Deeks 2011). Our primary
outcome measure (successful surgery) was dichotomous and so we
used the odds ratio.
Selection of studies
Unit of analysis issues

There were no unit of analysis issues. The only trial identified

included one eye of each participant and this was reflected in the
analysis.
Subgroup analysis and investigation of heterogeneity

We did not intend to conduct subgroup analysis. For future updates, we will investigate heterogeneity by careful review of the
study reports.
Dealing with missing data

In case we were unable to extract all the required information
from the included studies, we requested the missing data from the
investigators. A period of four weeks was allowed for the authors
to respond and if no response was provided after this period it was
recorded as missing data and the review was conducted based on
available information.
Sensitivity analysis
Assessment of heterogeneity
RESULTS
If additional trials are identified for inclusion in the future, heterogeneity will be assessed by careful review of the full-text papers.
We normally anticipate some degree of heterogeneity to be present
due to the clinical and methodological differences of the studies.
If they appear similar methodologically we will assess consistency
by examination of the I2 statistic. We considered values of I2 of
50% or greater to indicate substantial heterogeneity.
We plan to perform sensitivity analyses in order to determine the

impact of excluded studies of lower methodological quality and
unpublished studies.
Description of studies
See: Characteristics of included studies; Characteristics of excluded
studies; Characteristics of ongoing studies.
Results of the search

Assessment of reporting biases
If in the future there are a sufficient number of trials (10 or more),
we will use a funnel plot to assess evidence of publication bias.
Data synthesis
For future updates, if there is no evidence of heterogeneity between trials we will combine the results in a meta-analysis using
a random-effects model, unless the number of trials is three or
less when a fixed-effects model is used. If substantial statistical or
clinical heterogeneity is present we will not combine the studies
in a meta-analysis but will present a descriptive overview of the
outcome.
The electronic searches yielded a total of 294 titles and abstracts

and five reports of ongoing studies (Figure 1). After de-duplication
the Trials Search Co-ordinator scanned 267 records and discarded
156 records because they were not relevant to the scope of the
review. We screened the title and abstracts of the remaining 111
references. We rejected 108 abstracts as not eligible for inclusion in
the review. We obtained full-text copies of two reports for further
examination, one was excluded from the review by both review
authors on methodological grounds. One trial was included in the
review. We found one ongoing study (NTR1653) which is relevant
to the review. This trial has been added to the Characteristics of
ongoing studies table and will be included in the review when
data become available.

Figure 1. Results from searching for studies for inclusion in the review.

Included studies
We included one RCT and details are given below. For additional
information see the Characteristics of included studies table.
Scheepers 2010 compared everting sutures (for vertical tightening)
alone versus everting sutures with a lateral tarsal strip (for vertical
and horizontal tightening) in the treatment of involutional lower
lid entropion. The combined procedure was superior to the everting sutures alone as it produced no recurrences in the 18 month
postoperative observation. From this paper we obtained data specific to the primary or secondary outcome measures.
was also an unspecific statement about the statistical significance

of the comparison values and poor surgical justification of the
findings. It was impossible to obtain further clarification from the
authors or the journal. In addition the paper did not compare
two distinct surgical procedures but it only evaluated the results
of retractor plication performed with two different techniques.
The two treatment comparisons were so similar that it could not
be regarded truly as different surgical interventions as they both
addressed vertical lid laxity by reattaching the inferior retractors
to the tarsal plate.
Excluded studies
Risk of bias in included studies
We obtained the full-text copy of one of the reports for further

examination and excluded it (see the Characteristics of excluded
studies table). This paper (Altieri 2004) stated that the patients
were randomly assigned into two treatment groups but it was
unclear whether a valid randomisation method was used. There
We assessed the risk of bias for Scheepers 2010 by utilising the

Risk of bias assessment tool. This considers sequence generation,
allocation concealment, masking of physicians and participants,
incomplete outcome date, selective outcome reporting and other
potential threats to validity. See Figure 2.
Figure 2. Risk of bias graph: review authors judgements about each risk of bias item presented as
percentages across all included studies.
Allocation
In the only included trial, eligible participants were randomised
to everting sutures or everting sutures and lateral canthal strip by
drawing an envelope from a box that contained one of the two
randomisation assignments with half the participants randomised
to each group. For participants with bilateral disease, only the first
eyelid operated on was entered into the study.

No details of attempts to conceal allocation of intervention assignment were given posing a potential risk of bias.
Blinding

In this trial there is no evidence that physicians and participants

were masked (blinded) during the conduct and analysis of the
study. This poses a potential risk of bias.
Incomplete outcome data

Outcome data were reported for 55 of the 63 participants who
were enrolled in the study. This poses a potential risk of bias.
Selective reporting
The trial was evaluated to be free of selective outcome reporting.
The outcome measures listed in the methods were detailed in the
results of the study.
Other potential sources of bias

There is no evidence that the identified study might be subject to
other potential sources of bias.
Effects of interventions
Due to the single included study, a meta-analysis could not be
performed, therefore, the results are presented in a descriptive
manner.
The non-RCTs identified by the same search method or included
as selective summary are not robust enough to provide credible
evidence to the current understanding of involutional lower lid
entropion surgery and therefore their results will not be analysed.
DISCUSSION
The single RCT included in this review (Scheepers 2010) indicates that the combined procedure for horizontal and vertical eyelid tightening in the form of everting sutures and lateral tarsal strip
is highly curative for involutional entropion compared to vertical
tightening in the form of everting sutures alone. Although several suggestions for methodological improvements can be made
(Boboridis 2011), this study provides the only available robust
data to support evidence based guidelines for the management of
lower lid entropion.
Before the publication of high level evidence, it was the physicians
understanding of the involutional anatomical and pathophysiological causative changes for the inward turning of the lower lid,
along with uncontrolled, retrospective case series studies, that was
formulating the current clinical practice with similar conclusions
to the directions of surgical repair.
Vertical lid laxity corrected using the Wies procedure (Wies 1954)
has reported overcorrections of up to 10% and a recurrence rate
of 7/66 cases (11%) at a minimum of six months postoperative
follow up (Wies 1955). When combined with horizontal shortening, recurrence rates of 0/29 cases at a minimum of six months
follow up and 0/127 eyelids at an average follow up of 33 months
have been reported (Carroll 1991; Lance 1991). Some authors
quote a 3.7% recurrence rate for the combined procedure (Collin
1978) and 1.6% for indirect retractor attachment with everting
sutures combined with the tarsal strip procedure (Rougraff 2001).
Correction of vertical lid laxity in the form of retractor plication
with the Jones procedure (Jones 1963) has a reported recurrence
rate of 2/12 patients (16.6%) (Dryden 1978). The use of nonabsorbable sutures for the reattachment of the retractors to the
tarsal plate combined with partial myectomy of the preseptal orbicularis muscle has been reported to improve the recurrence rate
from 14.7% to 7.1% (Altieri 2004) which further decreases to 9/
266 cases (3.3%) in combined procedures (van den Bosch 1998).
In a case series study, horizontal lid and orbicularis tightening has
been shown to cure entropion in 36/45 cases (86%) (Olver 2000).
A retrospective case series suggested that Jones retractor plication
is more likely to permanently cure entropion than the Wies procedure (Boboridis 2000). This study reported recurrence rates of
2/37 patients (5%) and 11/65 patients (17%) respectively at an
average of 31 months of follow up. Recurrence occurred much
earlier after the Wies procedure. Another retrospective study, from
the same centre, suggested that successful outcome is more likely
when surgery for entropion also addresses horizontal lid laxity,
with a 2/180 patients (1%) recurrence rate compared with 29/133
patients (22%) when the lid is not shortened horizontally (Danks
1998).
These published reports from case series studies vary significantly
in the information on follow-up length and methodology affecting
the apparent success rate of each procedure (Glatt 1999). Evidence
from the available uncontrolled studies along with the only available RCT support the conclusion that direct vertical lid shortening
combined with horizontal lid shortening gives the most favourable
outcome in entropion surgery. Until more evidence in the form of
RCTs is available we cannot make firm recommendations regarding specific surgical techniques and clinical practice.
Summary of main results

The only RCT included (Scheepers 2010) provides evidence that
the combined procedure for horizontal and vertical eyelid tightening in the form of everting sutures and lateral tarsal strip offers
a higher success rate for involutional entropion compared to vertical tightening in the form of everting sutures alone. This trial
was however judged to be at risk of of several important sources
of bias. Until more trials become available we cannot make strong
suggestions regarding specific surgical technique.

Overall completeness and applicability of

evidence
The literature on surgical management of involutional lower lid
entropion consists predominantly of retrospective studies, cohort
studies and case series which cannot be used for the establishment
of reliable guidelines for the efficacy and safety of a specific procedure as a superior treatment intervention. One RCT was identified in this review which gives strong evidence for the direction of
surgical intervention and the relative effectiveness of two surgical
procedures.
The available evidence relates to the review question but it is insufficient to address all the review objectives as only two interventions are compared and numerous others are yet to be evaluated.
The target of surgical intervention for horizontal and vertical eyelid
tightening is uniformly supported by the available RCT and most
of the uncontrolled studies.
in most retrospective and case series studies (Boboridis 2000;

Danks 1998), that horizontal and vertical tightening of the eyelid
gives the most successful surgical outcome.
AUTHORS CONCLUSIONS
Implications for practice
Quality of the evidence
The only identified randomised controlled trial shows that the

combined procedure for horizontal and vertical eyelid tightening
in the form of everting sutures and lateral tarsal strip is more efficient compared to vertical tightening in the form of everting
sutures alone. Uncontrolled studies also suggest that combination of horizontal and vertical lower lid shortening provides more
favourable results compared to vertical shortening alone which is
associated with higher recurrence and complications rates. These
results from retrospective case series studies should be considered
with caution.
This review has identified a single RCT which has been found to
be at risk of several sources of bias.
Implications for research
Potential biases in the review process

Despite extensive searching we identified only one study that met
the inclusion criteria for this review. The available RCT was well
conducted yet still at risk of several important sources of bias. Bias
may distort systematic reviews and meta-analyses and encourages
the use of questionable treatments (Dickersin 1992). This is not
an issue for our review since we have not found adequate studies
to perform meta-analysis and make recommendations. It should
be noted that one of the authors of this review is an author of the
published RCT and thus grading of the quality of evidence of this
trial was left to the other author.
Agreements and disagreements with other

studies or reviews
At present, Scheepers 2010 provides the only robust data for lower
lid entropion which cannot be formally compared with other studies. The general findings of this trial agree with the evidence found
This review highlights the need for more randomised controlled

trials comparing interventions for lower lid entropion. However,
data from retrospective studies may present ethical difficulties in
randomising patients to certain less efficient procedures.
ACKNOWLEDGEMENTS
We are grateful to Michael Wearne for peer review comments and
to Anupa Shah for her assistance throughout the review process.
The Cochrane Eyes and Vision Group editorial team developed
the search strategies and undertook the electronic searches.
Richard Wormald (Co-ordinating Editor for CEVG) acknowledges financial support for his CEVG research sessions from the
Department of Health through the award made by the National
Institute for Health Research to Moorfields Eye Hospital NHS
Foundation Trust and UCL Institute of Ophthalmology for a Specialist Biomedical Research Centre for Ophthalmology. The views
expressed in this publication are those of the authors and not necessarily those of the Department of Health.

REFERENCES
References to studies included in this review

Scheepers 2010 {published data only}
Scheepers MA, Singh R, Ng J, Zuercher D, Gibson A,
Bunce C, et al.A randomized controlled trial comparing
everting sutures with everting sutures and a lateral tarsal
strip for involutional entropion. Ophthalmology 2010;117
(2):3525.
References to studies excluded from this review

Altieri 2004 {published data only}
Altieri M, Kingston AE, Bertagno R, Altieri G. Modified
retractor plication technique in lower lid entropion repair: a
4-year follow-up study. Canadian Journal of Ophthalmology
2004;39(6):6505.
References to ongoing studies

NTR1653 {unpublished data only}
NTR1653. Lateral eyelid block excision versus lateral tarsal
strip procedure to correct for horizontal eyelid laxity; a
randomized controlled non-inferiority trial. apps.who.int/
trialsearch/Trial.aspx?TrialID=NTR1653 (accessed 2
November 2011).
Additional references
Anderson 1979
Anderson RL, Gordy DD. The tarsal strip procedure.
Archives of Ophthalmology 1979;97(11):21926.
Bashour 2000
Bashour M, Harvey J. Causes of involutional ectropion
and entropion - age-related tarsal changes are the key.
Ophthalmic Plastic and Reconstructive Surgery 2000;16(2):
13141.
Boboridis 2000
Boboridis K, Bunce C, Rose GE. A comparative study
of two procedures for repair of involutional lower lid
entropion. Ophthalmology 2000;107(5):95961.
Boboridis 2011
Boboridis KG, Mikropoulos DG, Ziakas NG. Entropion.
Ophthalmology 2011;118(1):2256.
Carroll 1991
Carroll RP, Allen SE. Combined procedure for repair
of involutional entropion. Ophthalmic Plastic and
Reconstructive Surgery 1991;7(2):1237.
Clarke 1988
Clarke JR, Spalton DJ. Treatment of senile entropion with
botulinum toxin. British Journal of Ophthalmology 1988;72
(5):3612.
Collin 1978
Collin JR, Rathbun JE. Involutional entropion. A review
with evaluation of a procedure. Archives of Ophthalmology
1978;96(6):105864.
Collin 1989
Collin JRO. Entropion and trichiasis. A manual of systematic
eyelid surgery. 2nd Edition. Churchill Livingstone, 1989.
Damasceno 2011a
Damasceno RW, Osaki MH, Dantas PE, Belfort R Jr.
Involutional entropion and ectropion of the lower eyelid:
prevalence and associated risk factors in the elderly
population. Ophthalmic Plastic and Reconstructive Surgery
2011;27(5):31720.
Damasceno 2011b
Damasceno RW, Osaki MH, Dantas PE, Belfort R Jr.
Involutional ectropion and entropion: clinicopathologic
correlation between horizontal eyelid laxity and eyelid
extracellular matrix. Ophthalmic Plastic and Reconstructive
Surgery 2011;27(5):3216.
Danks 1998
Danks JJ, Rose GE. Involutional lower lid entropion: to
shorten or not to shorten?. Ophthalmology 1998;105(11):
20657.
Deeks 2011
Deeks JJ, Higgins JPT, Altman DG (editors). Chapter 9:
Analysing data and undertaking meta-analyses. In: Higgins
JPT, Green S (editors). Cochrane Handbook for Systematic
Reviews of Interventions Version 5.1.0 (updated March
2011). The Cochrane Collaboration, 2011. Available from
www.cochrane-handbook.org.
Dickersin 1992
Dickersin K, Min YI, Meinert CL. Factors influencing
publication of research results. Follow-up of applications
submitted to two institutional review boards. JAMA 1992;
267(3):3748.
Dryden 1978
Dryden RM, Leibsohn J, Wobig J. Senile entropion.
Pathogenesis and treatment. Archives of Ophthalmology
1978;96(10):18835.
Glanville 2006
Glanville JM, Lefebvre C, Miles JN, Camosso-Stefinovic J.
How to identify randomized controlled trials in MEDLINE:
ten years on. Journal of the Medical Library Association 2006;
94(2):1306.
Glatt 1999
Glatt HJ. Follow-up methods and the apparent success of
entropion surgery. Ophthalmic Plastic and Reconstructive
Surgery 1999;15(6):396400.
Higgins 2011
Higgins JPT, Altman DG, Sterne JAC (editors). Chapter
8: Assessing risk of bias in included studies. In: Higgins
JPT, Green S (editors). Cochrane Handbook for Systematic
Reviews of Interventions Version 5.1.0 (updated March
2011). The Cochrane Collaboration, 2011. Available from
www.cochrane-handbook.org.

10
Hintschich 2008
Hintschich C. Correction of entropion and ectropion.
Developments in Ophthalmology 2008;41:85102.
Jones 1963
Jones LT, Reeh MJ, Tsujimura JK. Senile entropion.
American Journal of Ophthalmology 1963;55:4639.
Jones 1972
Jones LT, Reeh MJ, Wobig JL. Senile entropion. A new
concept for correction. American Journal of Ophthalmology
1972;74(2):3279.
Lance 1991
Lance SE, Wilkins RB. Involutional entropion: a
retrospective analysis of the Wies procedure alone or
combined with a horizontal shortening procedure.
Ophthalmic Plastic and Reconstructive Surgery 1991;7(4):
2737.
Levine 1998
Levine RM, El-Toukhy E, Schaefer JA. Entropion. In: Nesi
AF, Lisman DR, Levine RM editor(s). Smiths Ophthalmic
Plastic and Reconstructive Surgery. 2nd Edition. St. Louis:
Mosby, 1998:27189.
Nordic Cochrane Centre, The Cochrane Collaboration,

2011.
Rougraff 2001
Rougraff P, Tse D, Johnson T, Feuer W. Involutional
entropion repair with fornix sutures and lateral tarsal strip
procedure. Ophthalmic Plastic and Reconstructive Surgery
2001;17(4):2817.
Skorin 2003
Skorin L Jr. A review of entropion and its management.
Contact Lens & Anterior Eye 2003;26(2):95100.
Tenzel 1969
Tenzel RR. Treatment of lagophthalmos of the lower lid.
Archives of Ophthalmology 1969;81(3):3668.
Tse 1992
Tse DT. Entropion. In: Tse DT editor(s). Color Atlas of
Ophthalmic Surgery: Oculoplastic Surgery. Pennsylvania: J.
B. Lippincott Company, 1992:10112.
van den Bosch 1998
van den Bosch WA, Rosman M, Stijnen T. Involutional
lower eyelid entropion: results of a combined approach.
Ophthalmic Surgery and Lasers 1998;29(7):5816.
Musch 1983
Musch DC, Sugar A, Meyer RF. Demographic and
predisposing factors in corneal ulceration. Archives of
Ophthalmology 1983;101(10):15458.
Wheeler 1938
Wheeler JM. Spastic entropion correction by
orbicularis transplantation. Transactions of the American
Ophthalmological Society 1938;36:15762.
Neetens 1987
Neetens A, Rubbens MC, Smet H. Botulinum A-toxin
treatment of spasmodic entropion of the lower eyelid.
Bulletin de la Societe Belge dOphtalmologie 1987;224:1059.
Wies 1954
Wies FA. Surgical treatment of entropion. Journal of the
International College of Surgeons 1954;21:75860.
Olver 2000
Olver JM, Barnes JA. Effective small-incision surgery for
involutional lower eyelid entropion. Ophthalmology 2000;
107(11):19828.
Pereira 2010
Pereira MG, Rodrigues MA, Rodrigues SA. Eyelid
entropion. Seminars in Ophthalmology 2010;25(3):528.
RevMan 2011
The Nordic Cochrane Centre, The Cochrane Collaboration.
Review Manager (RevMan).. 5.1. Copenhagen: The
Wies 1955
Wies FA. Spastic entropion. Transactions of the American
Academy of Ophthalmology and Otolaryngology 1955;59:
5036.
References to other published versions of this review

Boboridis 2002
Boboridis KG, Bunce C. Interventions for involutional
lower lid entropion. Cochrane Database of Systematic Reviews
2002, Issue 1. [DOI: 10.1002/14651858.CD002221]
Indicates the major publication for the study

11
CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Scheepers 2010
Methods
Randomised controlled trial with a minimum follow up of 18 months. Only one eye
per participant was included
Participants
Patients with involutional lower lid entropion requiring primary repair. 29 patients
received everting sutures alone (group 1) and 26 had the combination of everting sutures
and lateral tarsal sling (group 2)
Both groups were similar with respect to age, gender, and eye operated (gender Fishers
exact test 1.000; laterality Fishers exact test 0.298)
Interventions
Everting sutures plus lateral tarsal sling was compared with everting sutures alone
Outcomes
Recurrence of entropion, overcorrection, potential complications
Notes
Paper published in English
Risk of bias
Bias
Authors judgement
Support for judgement
Random sequence generation (selection Low risk

bias)
Clear details on the randomisation process

were given
Allocation concealment (selection bias)
High risk
No evidence of concealment
Incomplete outcome data (attrition bias)

All outcomes
Low risk
Incomplete outcome data was adequately

addressed with the main outcome measures
reported clearly for all participants
Selective reporting (reporting bias)
Low risk
No evidence of selective reporting
Other bias
Low risk
No evidence of other potential source of

bias
Blinding of participants and personnel High risk

(performance bias)
All outcomes
There is no evidence of participants masking (blinding) during the conduct and analysis of the study
Blinding of outcome assessment (detection High risk

bias)
All outcomes
There is no evidence of physicians masking during the conduct and analysis of the
study

12
Characteristics of excluded studies [ordered by study ID]
Study
Reason for exclusion
Altieri 2004
Unclear randomisation method. The two treatment comparisons are so similar techniques that it cannot be regarded
truly as different surgical interventions
Characteristics of ongoing studies [ordered by study ID]

NTR1653
Trial name or title
Methods
Participants
Patients who have an eyelid condition for which a surgical procedure is planned that includes lateral horizontal
eyelid tightening. The conditions include: ectropion, entropion, facial palsy, eyelid laxity due to ocular
prosthesis wear
Interventions
1. Lateral eyelid block excision.

2. Lateral tarsal strip procedure.
Outcomes
Surgical success at one year, defined as restoration of the lower eyelid position at the midline through the
pupillary centre and at the lateral canthus, without in- or outward rotation of the lower eyelid margin
Starting date
1 March 2009
Contact information
Dr. W.R. Bijlsma.University Medical Center Utrecht (UMCU), Oogziekenhuis Rotterdam (OZR)
Notes

13
DATA AND ANALYSES

This review has no analyses.
APPENDICES
Appendix 1. CENTRAL search strategy
#1 MeSH descriptor Entropion
#2 entropion or entropium
#3 (eyelid* or eye lid*) and (inver* or malposition*)
#4 (#1 OR #2 OR #3)
Appendix 2. MEDLINE (OVID) search strategy

1. randomized controlled trial.pt.
2. (randomized or randomised).ab,ti.
3. placebo.ab,ti.
4. dt.fs.
5. randomly.ab,ti.
6. trial.ab,ti.
7. groups.ab,ti.
8. or/1-7
9. exp animals/
10. exp humans/
11. 9 not (9 and 10)
12. 8 not 11
13. entropion/
14. (entropion$ or entropium).tw.
15. ((eyelid$ or eye lid$) and (inver$ or malposition$)).tw.
16. or/13-15
17. 12 and 16
The search filter for trials at the beginning of the MEDLINE strategy is from the published paper by Glanville et al (Glanville 2006).
Appendix 3. EMBASE (OVID) search strategy

1. exp randomized controlled trial/
2. exp randomization/
3. exp double blind procedure/
4. exp single blind procedure/
5. random$.tw.
6. or/1-5
7. (animal or animal experiment).sh.
8. human.sh.
9. 7 and 8
10. 7 not 9
11. 6 not 10
12. exp clinical trial/
14
13. (clin$ adj3 trial$).tw.

14. ((singl$ or doubl$ or trebl$ or tripl$) adj3 (blind$ or mask$)).tw.
15. exp placebo/
16. placebo$.tw.
17. random$.tw.
18. exp experimental design/
19. exp crossover procedure/
20. exp control group/
21. exp latin square design/
22. or/12-21
23. 22 not 10
24. 23 not 11
25. exp comparative study/
26. exp evaluation/
27. exp prospective study/
28. (control$ or prospectiv$ or volunteer$).tw.
29. or/25-28
30. 29 not 10
31. 30 not (11 or 23)
32. 11 or 24 or 31
33. entropion/
34. (entropion$ or entropium).tw.
35. ((eyelid$ or eye lid$) and (inver$ or malposition$)).tw.
36. or/33-35
37. 32 and 36
Appendix 4. metaRegister of Controlled Trials search strategy

entropion
Appendix 5. ClinicalTrials.gov search strategy

entropion
Appendix 6. ICTRP search strategy

entropion
WHATS NEW
Last assessed as up-to-date: 2 November 2011.
Date
Event
Description
4 November 2011
New citation required and conclusions have changed
With the inclusion of a new trial, the conclusions for

this review have been updated

15
(Continued)
4 November 2011
New search has been performed
Issue 12, 2011: Updated searches yielded one new trial

for inclusion (Scheepers 2010).
HISTORY
Protocol first published: Issue 3, 2000
Review first published: Issue 1, 2002
Date
Event
Description
11 October 2008
Amended
Converted to new review format.
20 November 2001
New citation required and conclusions have changed
Substantive amendment
CONTRIBUTIONS OF AUTHORS
Please place the initials of each author that is assigned to the tasks below
Conceiving the review: KB
Designing the review: KB, CB
Co-ordinating the review: KB, CB
Data collection for the review
- Designing search strategies: Cochrane Eyes and Vision Group
- Undertaking searches: Cochrane Eyes and Vision Group
- Screening search results: KB, CB
- Organising retrieval of papers: KB, CB
- Screening retrieved papers against inclusion criteria: CB, KB
- Appraising quality of papers: CB, KB
- Extracting data from papers: CB, KB
- Writing to authors of papers for additional information: KB
- Providing additional data about papers: KB
- Obtaining and screening data on unpublished studies: KB, CB
Data management for the review
- Entering data into RevMan: CB, KB
Analysis of data: CB, KB
16
Interpretation of data
- Providing a methodological perspective: CB
- Providing a clinical perspective: KB
- Providing a policy perspective: KB, CB
- Providing a consumer perspective: KB, CB
Writing the review: KB
Providing general advice on the review: CB
Securing funding for the review: CB, KB
Performing previous work that was the foundation of the current study: KB
DECLARATIONS OF INTEREST
Catey Bunce is an author on the Scheepers 2010 trial included in this review.
SOURCES OF SUPPORT
Internal sources
NIHR, UK.
Catey Bunce acknowledges financial support from the Department of Health through the award made by the National Institute for
Health Research to Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology for a Specialist Biomedical
Research Centre for Ophthalmology. The views expressed in this publication are those of the authors and not necessarily those of the
Department of Health.
External sources
No sources of support supplied
INDEX TERMS
Medical Subject Headings (MeSH)
Suture
Techniques; Entropion [pathology; surgery]; Randomized Controlled Trials as Topic
MeSH check words

Aged; Humans; Middle Aged

17

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Interventions for involutional lower lid entropion (Review)

Boboridis KG, Bunce C

Interventions for involutional lower lid entropion (Review)

Interventions for involutional lower lid entropion (Review)

Interventions for involutional lower lid entropion

PLAIN LANGUAGE SUMMARY

Description of the condition

constant rubbing of the eyelid margin, eyelashes and skin against

Interventions for involutional lower lid entropion (Review)

tarsal plate - loses its stiffness and inward buckling allows

Description of the intervention

How the intervention might work

Why it is important to do this review

Criteria for considering studies for this review

Types of outcome measures

Interventions for involutional lower lid entropion (Review)

Search methods for identification of studies

Data extraction and management

1. successful surgery i.e. normal eye lid position at rest.

Two authors independently extracted the following information

Assessment of risk of bias in included studies

Measures of treatment effect

Data collection and analysis

We sought guidance from Chapter 9 of the Cochrane Handbook

Unit of analysis issues

Interventions for involutional lower lid entropion (Review)

There were no unit of analysis issues. The only trial identified

Subgroup analysis and investigation of heterogeneity

Dealing with missing data

We plan to perform sensitivity analyses in order to determine the

Results of the search

The electronic searches yielded a total of 294 titles and abstracts

Interventions for involutional lower lid entropion (Review)

Interventions for involutional lower lid entropion (Review)

was also an unspecific statement about the statistical significance

Risk of bias in included studies

We obtained the full-text copy of one of the reports for further

We assessed the risk of bias for Scheepers 2010 by utilising the

eyelid operated on was entered into the study.

Interventions for involutional lower lid entropion (Review)

In this trial there is no evidence that physicians and participants

Incomplete outcome data

Other potential sources of bias

Summary of main results

Interventions for involutional lower lid entropion (Review)

Overall completeness and applicability of

in most retrospective and case series studies (Boboridis 2000;

Quality of the evidence

The only identified randomised controlled trial shows that the

Implications for research

Potential biases in the review process

Agreements and disagreements with other

This review highlights the need for more randomised controlled

Interventions for involutional lower lid entropion (Review)

References to studies included in this review

References to studies excluded from this review

References to ongoing studies

Interventions for involutional lower lid entropion (Review)

Nordic Cochrane Centre, The Cochrane Collaboration,

References to other published versions of this review

Indicates the major publication for the study

Interventions for involutional lower lid entropion (Review)

Characteristics of included studies [ordered by study ID]

Recurrence of entropion, overcorrection, potential complications