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Clinical science

Quality of diurnal intraocular pressure control in


primary open-angle patients treated with latanoprost
compared with surgically treated glaucoma patients:
a prospective trial
K Mansouri,1,2 S Orguel,1 A Mermoud,2 I Haefliger,1 J Flammer,1 E Ravinet,2
T Shaarawy3
1

University Eye Clinic Basel,


Basel, Switzerland; 2 Jules Gonin
Eye Hospital, University of
Lausanne, Lausanne,
Switzerland; 3 Glaucoma Sector,
Ophthalmology Clinic, University
of Geneva, Geneva, Switzerland
Correspondence to:
Dr T Shaarawy, Glaucoma
Sector, Ophthalmology Clinic,
University of Geneva, 22, rue
Alcide Jentzer, 1211 Gene`ve,
Switzerland; tarek.shaarawy@
hcuge.ch
Accepted 26 September 2007
Published Online First
22 January 2008

ABSTRACT
Purpose: To compare the intraocular pressure (IOP)
diurnal fluctuations of glaucoma patients treated with
latanoprost 0.005% once a day with patients with
controlled IOP after deep sclerectomy or trabeculectomy.
Methods: The trial included 60 prospectively recruited
subjects with primary open-angle glaucoma. The medical
group consisted of 20 patients with controlled IOP
(,18 mm Hg) under latanoprost 0.005% monotherapy
and with no history of previous intraocular surgery or
argon laser trabeculoplasty; the surgical groups included
20 patients after trabeculectomy, and 20 patients after
deep sclerectomy with collagen implant (DSCI). The
patients in the surgical groups had a controlled IOP
without any ocular hypotensive medications. All patients
underwent a diurnal tension curve (08:0017:00/threehour intervals), followed by a water-drinking test (WDT)
with the last IOP measurement taken at 21:00 hours. The
between-group differences were tested for significance
by means of analysis of variance (ANOVA).
Results: Baseline IOP was significantly different between
the trabeculectomy group (10.1 mm Hg (3.4 SD)), the
DSCI group (13.9 mm Hg (2.8)) and the latanoprost group
(15.5 mm Hg (2.0); p = 0.005). The average IOP during
the diurnal tension curve (10.1, 13.7, and 15.7 mm Hg,
respectively, for the trabeculectomy, DSCI, and latanoprost groups) differed significantly between groups
(ANOVA; p,0.0001), but the variation was comparable in
the three groups (ANOVA; p = 0.13). After the WDT,
elevation of IOP was significantly greater among patients
treated with latanoprost (p = 0.003).
Conclusion: Trabeculectomy patients had a statistically
significant lower average IOP in the diurnal tension curve
compared with the other two groups. No wider variation
in diurnal IOP with latanoprost compared with the surgical
procedures was found. The IOP increase during the WDT
was most marked in patients under latanoprost therapy.

Intraocular pressure (IOP) has been recognised as a


major risk factor for the development of glaucoma
and is subject to cyclic fluctuations throughout the
day. Diurnal variation in glaucoma was first
reported in 1898.1 IOP diurnal fluctuations have
been identified as a significant and independent
risk factor in glaucomatous progression.25 It has
been suggested that the progressive damage in
some cases could be caused by peaks of IOP or
diurnal IOP variability not detected by tonometry
during office hours. There is evidence that patients
controlled after filtering surgery have fewer IOP
332

fluctuations during the diurnal tension curve and


after a water-drinking provocative test (WDT)
than medically controlled patients.6 The WDT,
popular in the 1950s and 1960s, was later discarded
as a diagnostic tool for open-angle glaucoma
because of low sensitivity and specificity.7 8 In
recent years, the WDT has been identified as a
reliable and safe tool to predict maximum IOP
values during a diurnal tension curve (DTC) and to
assess the patency of surgical interventions.911
The prostaglandin analogue latanoprost 0.005%
seems to lead to a fairly uniform circadian
reduction in IOP without peaks, compared with
other IOP-reducing medications, such as timolol
and dorzolamide.12 13 To date, and to the best of
our knowledge, however, there are no studies in
the literature comparing IOP fluctuations in
latanoprost medically controlled versus surgically
controlled glaucoma patients.
The purpose of this study was to evaluate the
IOP fluctuation rate during the DTC and the
response to the WDT in patients controlled with
latanoprost compared with patients controlled
after trabeculectomy and deep sclerectomy with
collagen implant (DSCI).

MATERIALS AND METHODS


This multicentre trial was conducted at the
Glaucoma Surgery Research Unit, Department of
Ophthalmology, University of Basel and the
Glaucoma Unit of the Jules Gonin Eye Clinic,
University of Lausanne. Sixty eyes of 60 patients
with primary open-angle glaucoma (POAG) were
enrolled between the two centres.

Patient selection
All patients were enrolled consecutively from a
population of glaucoma patients already under one
of the three treatments. The medical group
consisted of 20 patients with a controlled IOP
under latanoprost 0.005%, administered as a single
drop in the evening, as the sole ocular hypotensive
medication and with no history of previous
intraocular filtering surgery. The surgical group
consisted of 40 patients previously submitted to
filtering surgery and controlled postoperatively
with no ocular hypotensive medication. This group
was subdivided into 20 patients who had previously been submitted to trabeculectomy and 20
patients who had previously been submitted to
Br J Ophthalmol 2008;92:332336. doi:10.1136/bjo.2007.123042

Clinical science
DSCI. Controlled IOP was defined as IOP less than 18 mm Hg
during the previous two visits in office hours. In the medical
group, the patients had been on a stable ocular hypotensive
medication regimen for at least three months. All trabeculectomies were performed using antimetabolites by two experienced surgeons. Deep sclerectomies were performed without the
use of antimetabolites by two experienced surgeons. Operations
had been performed at least one year before inclusion in the
study.
All patients had typical glaucomatous optic nerve atrophy
and glaucomatous visual field defects, as defined by previously
published criteria.14 The exclusion criteria were (1) baseline
untreated IOP (surgery group) or treated IOP equal to or higher
than 18 mm Hg; (2) pseudoexfoliative and pigmentary glaucomas; (3) previous treatment with argon laser trabeculoplasty or
refractive surgery; (4) corneal abnormalities preventing reliable
IOP measurement; and (5) women who were pregnant or of
child-bearing potential and not using adequate contraception.
Informed written consent was obtained from the subjects after
explanation of the nature and possible consequences of the
study. The study adhered to the tenets of the Declaration of
Helsinki.
Immediately after admission, all patients were submitted to a
DTC, which consisted of four IOP measurements at three-hour
intervals (08:00 to 17:00). Patients in the medical group were
advised not to take any latanoprost during the study hours.
After the 17:00 hour IOP measurement, the patients were
submitted to the WDT. The patients were instructed to fast
during the four-hour period preceding the test. The test was
carried out in a standardised manner: the patient was required
to drink one litre of tap water over 15 minutes. After that, IOP
was measured a total of three times at 15-minute intervals. The
last IOP measurement was taken at 21:00 hours, after which the
patient was discharged. All IOP measurements were performed
using the same Goldmann applanation tonometer (HaagStreit,
Bern, Switzerland) by the same experienced examiner. The
mean of three measurements was used for each timepoint.
The following parameters were used for data analysis: the
mean diurnal IOP was obtained by averaging all of the IOP
readings of the diurnal tension curve (excluding the WDT). The
difference between the highest and the lowest value was taken
as the diurnal range. The difference in IOP between the peak of
the three measurements after the WDT and the baseline (IOP
immediately before WDT) was considered as the IOP fluctuation during the WDT.

Statistical analysis
The sample size calculation was based on the assumption that a
difference in mean IOP of 2.5 mm Hg is clinically relevant. In
order to reach a power of 1-b = 0.90, given a = 0.05 and a SD

Figure 1 Mean intraocular pressure (IOP) levels for the medical


compared with the surgical groups.
DSCI, deep sclerectomy with collagen implant; TE, trabeculectomy;
WDT, water-drinking provocative test.
of 2 mm Hg, 15 patients were needed. We included 20 patients
in each group to achieve a power of over 90%. A 3 6 4 analysis
of variance (ANOVA) model was used to analyse the IOP
variation. All calculations were performed using SPSS version
11.5 (SPSS Inc, Chicago, Illinois, USA). A p value of 0.05 or less
was considered significant.

RESULTS
Sixty patients were included in the trial, 40 patients in the
surgery group and 20 in the medical group. No relevant
statistically significant differences were found between the
treatment groups with respect to demographic characteristics
(table 1). All patients completed all evaluation phases and no
adverse effects related to the study methodology (particularly
the WDT) were recorded. The mean defect (MD) on visual
fields was 9.18 (7.71; trabeculectomy), 6.81 (5.09; DSCI), and
3.09 (4.01; latanoprost; p,0.05).
The mean IOP at enrolment into the study was 11.4 (SD
4.4) mm Hg (trabeculectomy), 13.3 (3.4) mm Hg (DSCI), and
14.8 (2.3) mm Hg (latanoprost). The difference was significant
(ANOVA p = 0.006). IOP at 08:00 hours (baseline), 11:00, 14:00,
and 17:00 was 10.4 (3.4), 10.1 (4.1), 9.4 (3.8), and 10.4 (3.8) mm
Hg, respectively, for the trabeculectomy group. The values were
13.7 (2.7), 14.6 (3.1), 13.1 (3.2), and 13.8 (3.3) mm Hg for the
DSCI group, and 15.5 (2.0), 15.9 (1.7), 15.4 (2.1), and 15.9
(2.0) mm Hg for the latanoprost group. The mean IOP during
the diurnal tension curve (10.1, 13.7, and 15.7 mm Hg,
respectively, for the trabeculectomy, DSCI, and latanoprost
groups) differed significantly between the treatment groups
(ANOVA p,0.0001), and variation in IOP throughout the day
was significant (ANOVA 0.0002), but this variation was

Table 1 Patient demographics


Characteristics of patients

Trabeculectomy

DSCI

Latanoprost

p Value

No of patients
POAG/NPG
Men/women
White/black
Mean age, years (SD)
Baseline IOP, mm Hg
Mean SD

20
20/0
13/7
20/0
67.1 (9.24)
10.1
3.4

20
18/2
7/13
20/0
72.5 (11.9)
13.9
2.8

20
19/1
8/12
20/0
71.2 (10.4)
15.5
2.0

NS
NS
,0.05
NS
,0.05
NS

DSCI, deep sclerectomy with collagen implant; IOP, intraocular pressure; POAG, primary open-angle glaucoma; NPG, normal
tension glaucoma.
Applied tests were chi-square or ANOVA when adequate.

Br J Ophthalmol 2008;92:332336. doi:10.1136/bjo.2007.123042

333

Clinical science
Table 2 Mean IOP (mm Hg) preceding the WDT and at each timepoint (15, 30, and 45 minutes) after the
WDT for the medical compared with the surgical groups

IOP pre-WDT
WDT 15 minutes
WDT 30 minutes
WDT 45 minutes
WDT IOP fluctuation{

Trabeculectomy,
N = 20
(SD)

DSCI,
N = 20
(SD)

Latanoprost,
N = 20
(SD)

p Value*

10.1
11.6
12.5
12.2
+2.4

13.8
16.5
17.6
16.9
+3.8

15.9
19.8
21.1
20.6
+5.2

,0.05
,0.05
,0.05
,0.05
,0.05

(3.8)
(4.5)
(4.4)
(5.1)

(3.3)
(3.9)
(3.6)
(4.2)

(2.0)
(2.8)
(2.9)
(2.8)

DSCI, deep sclerectomy with collagen implant; IOP, intraocular pressure; WDT, water-drinking provocative test.
*Analysis of variance.
{The difference in IOP between the peak of the three measurements after the WDT and IOP immediately before the WDT.

comparable in the three groups (ANOVA p = 0.13). Post-hoc


comparison using the Tukey honest significant test disclosed a
lower average IOP during DTC in the trabeculectomy group
compared with the other two groups (p,0.001), but the
difference between DSCI and latanoprost was not significant
(p = 0.1; fig 1).
Changes in intraocular pressure after the WDT are shown in
table 2. The average value for IOP during the WDT was
significantly different (ANOVA p,0.0001). Peak values were
reached after 30 minutes and IOP varied significantly during the
45 minutes (ANOVA p,0.0001) and was statistically different
between the three treatment groups (ANOVA p = 0.003). Posthoc analysis using the Tukey honest significant test disclosed
statistically comparable variability between the DSCI group and
the trabeculectomy group (p = 0.31), but the difference between
the trabeculectomy group and the latanoprost group reached
statistical significance (p = 0.0002) and was of borderline
significance between the DSCI group and the latanoprost group
(p = 0.054), indicating a higher variability of IOP during the
WDT among patients treated with latanoprost. IOP values at
21:00 hours reached pre-WDT levels (9.4 (3.9), 14.5 (2.9), 16.9
(2.9) mm Hg, respectively, for the trabeculectomy, DSCI, and
latanoprost groups) and seemed to be unaffected by the WDT.

DISCUSSION
The aim of the present study was to show if fluctuations in IOP
differ significantly between patients controlled by trabeculectomy, DSCI, or latanoprost. Our results show that IOP varies
significantly throughout the day, but this variation is not
different between the groups. We found a significantly more
marked increase in IOP with latanoprost during the WDT.
To the best of our knowledge, this issue has not been
addressed before. Previous studies always compared mixed
medical groups with surgery and were mostly conducted before
the introduction of the prostaglandin analogues. Migdal and coworkers15 analysed the functional outcome after early surgery
compared with laser and medicine but that study was
conducted before the introduction of newer classes of ocular
hypotensive medications. A study by Medeiros et al6 demonstrated that patients previously submitted to trabeculectomy
showed less variability in IOP than patients under a mixed
group of ocular hypotensive treatments. A recent study by
Konstas et al16 confirmed this outcome and found the mean 24hour pressure control to be more stable in a surgical (n = 30)
compared with a medically controlled group (n = 30).
Despite their conclusions, these pertained only to a mixed
group of medications and might not be the result achieved with
every single component of the mixed group. Furthermore, the
comparability between the study of Konstas et al16 and ours is
334

rendered more difficult because of methodological differences.


Our study spans over 13 daytime hours compared with the 24hour pressure measurements of Konstas et al;16 the latters
medical group was under maximum tolerated therapy (ie two to
four medications) compared with latanoprost monotherapy in
our group. Contrary to the study of Konstas et al,16 we excluded
patients with pseudoexfoliative glaucoma as a result of
demonstrated higher diurnal IOP fluctuations.17 18
Furthermore, the statistical powers of the two studies were
different from one another. The study of Konstas et al16 had a
power of 1-b = 0.80 compared with 1-b = 0.90 in this study,
assuming an IOP of 1.5 mm Hg versus IOP of 2.5 mm Hg and a
SD of 2.8 mm Hg versus SD 2 mm Hg between treatments as
clinically relevant. Their patients were matched by IOP (1 mm
Hg SD), whereas we decided not to match our subjects.
Prostaglandin analogues, with their reported IOP reduction
and safety profile, have become an important element of
medical antiglaucomatous therapy in industrialised countries.
Here resides the specific aim of this study and its potential
value. Latanoprost was chosen because it has shown less
significant fluctuations compared with timolol and dorzolamide.12 In another study, Susanna and co-workers19 reported
that latanoprost had significantly less IOP fluctuations in
response to the WDT than unoprostone. It has also been
reported that topical medications that enhance outflow, such as
prostaglandins, may provide better IOP stabilisation under
stressful conditions than those that decrease aqueous humour
production.20 The WDT is thought to simulate one of these
stressful situations. We employed a similar definition of
clinically relevant fluctuations (2.5 mm Hg) in order to make
our results comparable to previously published papers.
We investigated the diurnal IOP at five timepoints covering a
period of 13 daytime hours and conducted the WDT to help
establish the IOP stability of patients controlled with any of the
three management options. Our raw, unadjusted data showed
statistical significance in favour of trabeculectomy in terms of
absolute IOP levels, and response to the WDT.
After the WDT, the IOP level varied significantly during the
experiment. Post-hoc analysis showed that the response of
patients treated with latanoprost was significantly more
pronounced. We conducted the WDT at the time of the trough
effect of latanoprost (17:00 hours).21 Therefore, it could be
speculated that the response to WDT might be different
between the three treatment groups depending on the timepoint of the day. The 24-hour fluctuation of latanoprost has
been reported to be in the range of 2.0 to 4.4 mm Hg.12 22
Konstas et al13 found a diurnal IOP of 2.4 mm Hg in a series of
103 patients with pseudoexfoliative glaucoma under latanoprost monotherapy who were submitted to four daytime
Br J Ophthalmol 2008;92:332336. doi:10.1136/bjo.2007.123042

Clinical science
measurements (08:00 to 20:00 hours). Their data compared well
with our results that show a diurnal fluctuation of 1.7 mm Hg
in POAG patients. The higher WDT fluctuation of 5.7 mm Hg
that was obtained in our series is situated close to the upper
range of 24-hour measurements.23
Our results are in agreement with Paletta Guedes et al24 who
specifically looked at the IOP response after WDT of 15 patients
under a fixed timolol 0.5%dorzolamide combination compared
with 21 patients submitted to deep sclerectomy (without
collagen implant) and 20 patients submitted to trabeculectomy.
A fourth group included 20 non-glaucomatous individuals. They
showed that IOP variations after the WDT were similar in nonglaucomatous individuals and in patients submitted to either
deep sclerectomy or trabeculectomy.
One limitation of the present study was that, as a result of
logistical constraints, we could not conduct a 24-hour observation and therefore night time IOP were not assessed. Earlier
reports concluded that the WDT is a reliable tool to detect IOP
peaks of 24-hour IOP fluctuations.6 8 2528 Like most provocative
tests, the WDT is a raw method and its findings should be
interpreted carefully, particularly so because at present there is
no standardised way of conducting this test. Depending on the
study centre, the amount and duration of fluid intake can vary
substantially. One more factor that is usually not taken into
consideration and that might influence test outcomes is the
weight of the patient, for which no adjustment factor has been
proposed in the literature. This is of particular importance
because the WDT is thought to predict the IOP peak of the
diurnal tension curve by causing osmotic variations. Recent
research suggests that there is no relationship between body
mass index and WDT results.29 More research is needed to
elucidate these and other confounding factors for the WDT.
Our results show that the visual field MD were significantly
lower in the medical group, whereas the difference between the
surgical groups was not significant. These groups had a MD of
more than 6.0 dB in the majority of patients, which falls into
the category of moderate to advanced glaucoma as defined by
Hodapp et al.30 This result can be explained by the fact that
generally patients are operated when in a more advanced stage
of disease.
This study only looked at diurnal fluctuations on a single day.
There is, however, no physiological reason to assume that
fluctuations in the course of one day are more relevant than
fluctuations between different days. As Niesel and Flammer31
and Flammer and co-workers32 have shown, there are numerous
reasons to believe that the total fluctuations between different
days are also important. To the best of our knowledge, a
clinically important difference in diurnal or 24-hour fluctuation
has not been well established. This value might be 1 mm Hg,
but no consensus exists here. Furthermore, daily IOP fluctuations have not yet clearly been linked to visual field progression.
The Early Manifest Glaucoma Trial has recently been analysed
in that sense.33 It could be shown that with increasing IOP
levels, IOP variability also increases. For this reason, we had
included the WDT in order to provoke those higher levels of IOP
and we were able to demonstrate a significant difference
between latanoprost and surgical interventions.
In this study all deep sclerectomy procedures were performed
without the use of antimetabolites, whereas the trabeculectomies were carried out with antimetabolites. This fact could
explain the difference in baseline IOP levels between these two
groups because the use of antimetabolites such as mitomycin C
and 5-fluorouracil has been associated with lower IOP levels
after non-penetrating glaucoma surgery.34
Br J Ophthalmol 2008;92:332336. doi:10.1136/bjo.2007.123042

CONCLUSION
This study shows that trabeculectomy patients had a statistically significant lower average IOP in the diurnal tension curve
compared with the other two groups. No wider variation in
diurnal IOP with latanoprost compared with the surgical
procedures was found. The increase in IOP after the WDT
was, however, significantly different between the groups; with
the lowest increase in trabeculectomy eyes, followed by DSCI
and latanoprost. This increase might indicate potentially higher
diurnal intraocular pressures in patients under latanoprost
monotherapy, particularly in situations under physiological
stress (as stimulated by the WDT).
Our results, however, pertain to only one member of the
commercially available prostaglandin family. More studies are
needed to compare other prostaglandin analogues as well as
different classes of ocular hypotensive medications with surgical
methods in terms of IOP fluctuations. Furthermore, the
selection of only well-controlled patients precludes any generalisation of the present results to the entire glaucoma population.
Also worthy of note is the fact that this study addresses one
aspect of the glaucoma continuum, namely diurnal pressure
control. In the framework of a comprehensive management of
the glaucoma patient the risk/benefit ratio should also be taken
into consideration as it significantly differs for each treatment
regimen and should be individualised for each patient.
Acknowledgements: The authors had full access to all the data in the study and
take responsibility for the integrity of the data and the accuracy of the data analysis.
They would like to acknowledge Dr Andreas Schoetzau for assistance in statistical
analysis.
Funding: This trial was supported by an unrestricted research grant from Pfizer AG,
Switzerland.
Competing interests: None.
The article was presented in part at the International Glaucoma Symposium, Cape
Town, South Africa, April 2005.

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Date for your diary


International Forum on Quality & Safety in Health Care
2225 April 2008
Le Palais de Congre`s de Paris
Paris, France
http://www.internationalforum.bmj.com
Why attend?
c Join over 1000 healthcare professionals from over 40 countries worldwide
c Learn from experienced leaders and improvement experts
c Find out what is current in quality and safety
c Gain new skills and tools for creating change in your organisation
c Take home practical solutions for improvement methods
c Network with like-minded colleagues
This is a premier event for those dedicated to improving quality and safety in healthcare. Our focus is
on practical, take-home ideas that will leave you inspired to implement valuable, lasting change on your
return to the workplace.
Register online from January 2008 onwards
For more information on the forum visit - http://www.internationalforum.bmj.com

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