Ophthalmic Epidemiology
0928-6586/04/US$ 22.00
Ophthalmic Epidemiology
2004, Vol. 11, No. 4,
pp. 319329
DOI: 10.1080/09286580490515116
2004 Taylor & Francis Ltd.
Abstract
purpose The aim of this study was to compare the incidence of Nd :
YAG laser capsulotomy after cataract surgery according to the type
of intra-ocular lens material (PMMA, silicone, hydrophilic acrylic,
hydrophobic acrylic) implanted in four European countries (France,
Italy, Germany, Spain).
design A retrospective record review.
participants A review of 1525 patients (first operated eye), aged 50
to 80 years, operated on for cataract in 1996 or 1997 in 16 surgical
centers (4 per country).
methods The study employed a retrospective cohort design. Charts
were reviewed to collect information during at least a three-year period
Results of the European IOL study
Correspondence and
reprint requests to:
Andrew F. Smith, PhD
Health Economics Unit,
Alcon Laboratories Ltd.
Pentagon Park, Boundary Way
Hemel Hempstead
England HP2 7UD
U.K.
Tel.: +44-1442-341-186
Fax: +44-1442-341-299
E-mail: andrew.f.smith@alconlabs.com
Acknowledgements:
This paper was presented at the XX
Congress of the European Society of
319
The debate is still ongoing as to the factors other than material, such
as the optical design and shape, design and material of haptics, quality
of finishing, surface irregularities and other factors, which have been
associated with different PCO rates for different IOLs. The newer generation of lenses, however, tend to present better results than older
ones.14 It has also been shown that sharp-edge optical designs of different materials help to reduce PCO.15,16
Other surgical factors have also demonstrated their importance in
this discussion,17 including cortical clean-up, quality of fixation and continuous curvilinear capsulorhexis.
The purpose of this study, therefore, was to compare the incidence of
Nd : YAG laser capsulotomy after cataract surgery between the main
types of IOL material (PMMA, silicone, hydrophilic acrylic or
hydrophobic acrylic) implanted in a large population in four European
countries (France, Germany, Italy and Spain). To ensure the transparency of the results, it should again be noted that both Dr. Smith and
Dr. Berdeaux are employees of Alcon Laboratories.
Material and methods The study was designed as a retrospective cohort based on patient chart review. As the Nd : YAG rate after
cataract surgery has been shown to increase dramatically during the
third year after operation, the duration of follow-up was determined
to be a minimum of 3 years.15
The occurrence of Nd : YAG laser capsulotomy was selected as the
primary criterion to assess IOL implantation complications, even if the
underlying problem was PCO. This is mainly because no international
scale was available to quantify PCO and furthermore, it would have
been nearly impossible to retrieve this information retrospectively. The
International Advisory Board of the study (AB, GA, AC, JM) decided
that in a retrospective study, Nd : YAG laser treatment was the best and
only single criterion for a comparison of IOL implantation complications according to the material, if the numbers of different IOLs were
balanced across the four countries.
The members of the Scientific Committee selected the centers on the
basis of well-recognized centers, with high activity and facility for
follow-up of patients, with few local competitors and a strong network
of physicians who could be easily contacted.
The specific inclusion criteria consisted of patients, of either gender,
with an age above 50 in order to avoid non-age-related cataract and
below 80 at the time of surgery in order to prevent a high rate of loss
to follow up due to mortality, who underwent cataract surgery between
1/1/1996 and 31/12/1997 using the phacoemulsification technique with
IOL implantation in the capsular bag. Furthermore, the optical size of
the lens must have been between 5.5 and 6.5 mm in diameter; However,
other diameters were included due to particular local circumstances
(the silicone lenses in Spain were larger than 6.5 mm). The exclusion
criteria consisted of any of the following: age lower than 50 or greater
than 80 year at the time of surgery, previous enrolment in this study,
previous surgery for that eye, concomitant ocular pathologies (uveitis
or history of uveitis, high myopia (6 spherical equivalent), combined
surgery, previous trauma), complications during surgery (posterior
Results of the European IOL study
321
322
Variable
Hydrophilic
acrylic
PMMA
Hydrophobic
acrylic
Silicone
p
Value
Male (%)
Age (mean, years)
Patients with
glaucoma (%)
Other eye previously
operated (%)
DVA before surgery
(mean)
DVA after surgery
(mean)
43.2
71.9
10.2
51.6
69.5
5.7
42.8
69.8
10.5
40.6
70.3
5.2
0.011
<0.001
0.005
31.6
31.3
40.9
28.2
<0.01
0.32
0.23
0.25
0.29
<0.01
0.78
0.75
0.74
0.78
0.02
323
general results at end of follow-up Patients were followed until the beginning of 2002. The mean duration of follow-up was
3.2 years and at the end of the follow-up period, 85 patients were dead
and 1,433 were alive. Of the patients (n = 1178) who did not die or did
not have Nd : YAG during the follow-up period, 16.7% were lost to
follow-up during the first year, 5.6% during the second year and 7.1%
during the third year. More than 70% of the patients were followed for
more than three years. Of the total population, more than 77% were
completely assessed.
PCO was noted in the medical records in 345 patients and 264
patients were treated with Nd : YAG laser.
The reasons for treatment by Nd : YAG laser were decreased visual
acuity in 90.2% of the patients, complaints from the patient in 20.2%
and to allow for fundus examination in 2.3%. No reason was provided
for five patients (1.9%).
Mean delay for Nd : YAG laser treatment from the date of operation
was 2.48 1.70 years, ranging from 0 to 5.88 years. The rate of occurrence of Nd : YAG laser treatment in the unscathed patients at the time
of measurement was low during the first two years (less than 1%),
increased to 2.4% at year three, doubled at year four to 5.8% and
reached 16.8% of the remaining patients at year 5.
Nd : YAG laser treatment rates were investigated according to different relevant variables. In the multivariate analysis, the Nd : YAG
laser rates were not affected by glaucoma, high intra-ocular pressure,
ARMD and diabetic retinopathy.
There was a statistically significant difference between patients with
other concomitant morbidities with the potential to impede vision
before surgery (n = 68) and those without (p = 0.0429); however, the
number of patients was too low to have any influence on the results of
the present study.
analysis according to type of IOL As shown in Table 2, there
were highly significant differences between the IOL groups for PCO
incidence (p < 0.001) and for Nd : YAG laser treatment occurrence
(p < 0.001).
The survival analysis that was performed is presented in Figure 1. Cox
model estimates between IOL types were performed and are presented
in Table 3. Variables included in the Cox model were age, gender and
country. Hydrophobic acrylic was the reference group.
The hazard ratio (HR) for females was 1.5 (p = 0.0012) and no difference was observed in the HR for age. The HR of the different countries as compared to France were all significant with 0.487 for Germany,
0.147 for Italy and 0.446 for Spain.
analysis by country An analysis of the operated population by the
country where the surgery was performed showed that there was a
similar distribution of IOL material across the countries except for
324
Type of IOL
Hydrophilic
acrylic
PMMA
Hydrophobic
acrylic
Silicone
All
patients
384
108
28.3%
74
421
37
8.9%
30
426
69
21.6%
69
1525
345
22.8%
264
7.1%
2.3
16.2%
2.6
17.3%
2.5
19.3%
2.7
Type of IOL
Number
P-value of
log-rank test
Hazard ratio of
Cox model
p value of
Cox model
Hydrophobic acrylic
Hydrophilic acrylic
PMMA
Silicone
419
292
384
426
<0.0001
<0.0001
< 0.001
1.00
4.50
2.58
2.69
< 0.001
< 0.001
< 0.001
Taking into account the confounding factors age, gender and country.
table 3. Comparison of
hydrophobic acrylic with the other
IOL types (log-rank test).
100%
90%
A
80%
70%
60%
A) Hydrophobic (n=419)
B) Silicone (n=426)
50%
C) PMMA (n=384)
D) Hydrophilic (n=292)
40%
0
n=1525
n=1304
n=1215
Year
n=1084
n=738
Fig. 1. Percent of living patients without Nd : Yag laser therapy over time according to the type of IOL (n = patients alive,
without Nd : Yag therapy, and followed at the beginning of the year).
325
Variable
Germany
Italy
France
Spain
p value
Number of patients
Male (%)
Presence of glaucoma (%)
DVA before surgery (mean)
DVA after surgery (mean)
Evolution of DVA (mean)
PCO (assessed by
physician)
Nd : YAG rate
PCO treated with
Nd : YAG
Reason for Nd : YAG: DVA
decreased
Patient complaints
416
38.9
15.1
0.30
0.66
0.36
23.2%
367
50.1
7.1
0.26
0.76
0.50
15.5%
363
43.8
3.1
0.30
0.80
0.49
28.4%
379
45.6
6.9
0.23
0.84
0.61
24.0%
0.011
<0.001
<0.001
<0.001
<0.001
<0.001
19.8%
85.4%
8.7%
56.0%
25.9%
93.0%
14.8%
61.5%
<0.001
80.5%
90.6%
95.7%
94.6%
0.006
15.9%
18.8%
33.3%
5.4%
<0.001
326
tively for at least one year; 1,592 eyes received an acrylic lens and 1,080
a silicone one. Cox proportional hazards ratios were calculated to
compare the risk of capsulotomy according to the type of lens. The risk
was found to be 3.6 times as high with silicone IOLs as compared with
acrylic IOLs (p < 0.0001). Two years postoperatively, the Nd : YAG laser
therapy rates were 4.15% and 14.04 % with acrylic and silicone lenses,
respectively.
In our study, it should be pointed out that since the Nd : YAG laser
rates did not decrease to very low levels over the study time period,
longer follow-up times would be required to establish whether there
would be any true difference in the Nd : YAG rates by IOL type over
the long term, although given the foreshortened time period of the
current study, this was not possible to detect.
In this multicenter European study, hydrophobic acrylic IOLs
showed a statistically significant lower rate of Nd : YAG laser treatment
than the other types of IOLs (p < 0.0001). These results, based on a
large population sample, were obtained taking into account differences
such as age, gender and country and clearly showed that the Nd : YAG
rates according to the type of IOL in current practice favored
hydrophobic acrylic IOLs.
Our results confirm previously published studies on a large number
of patients, using the current best practice management for cataract and
in different European health care systems. Apart from PCO, the timing
of when to perform Nd : YAG laser capsulotomy may depend on other
factors such as the level of visual acuity, patient satisfaction and other
characteristics such as financial incentives for professionals, etc.
In a retrospective study such as ours, the main problem is associated
with the difficulty to obtain relevant information. The relatively low
number of patients lost to follow-up is due to the proper selection of
the centers. The study highlighted several interesting results on the differences between countries. With a retrospective design and random
selection, investigators were not influenced by the study protocol. Sex
ratios were different in the four countries and that needs to be analysed
in relation to the current sex-ratios of the populations. Patients were
treated at a more advanced stage, as assessed by a lower DVA before
surgery, in Italy and Spain, but surprisingly, the benefit in DVA was
better in Spain than in the other countries. PCO was more commonly
assessed in France and Germany, and French ophthalmologists were
more likely to treat patients with PCO with Nd : YAG laser. French
patients were also more affected by their decrease in DVA. In Italy,
PCO was less frequently assessed by ophthalmologists and they were
less likely to perform Nd : YAG laser capsulotomy. These inter-country
variations owe their origin to factors in health care organization and
funding.
In summary, this European multi-center study showed that in a
large series of patients covering different national and demographic
factors, implantation of a hydrophobic acrylic intra-ocular lens with
sharp optical edges after cataract surgery resulted in a significantly
lower incidence of Nd : YAG laser treatment for posterior capsular
opacification.
327
References
328
10
11
12
13
14
15
16
17
Appendix
The European PCO study group comprised:
A. Brezin, Paris, F. Blondeau, Saumur, T. Amzallag, Somain, E.
Ribaute, Quimper, C. Billotte, Caen, A. Lafuma, Bourg la Reine, G.
Berdeaux (Alcon Laboratories), Rueil Malmaison, France;
A. Caporossi, Siena, M. Nardi, Pisa, A. Scialdone, Milan, A. Rapisarda, Siracusa, Italy;
G. Auffarth, Heidelberg, E. Mehdorn, Aachen, K. Gerstmeyer,
Minden, H. B. Dick, Mainz, Germany;
X. Mendicute, San Sebastin, L. Cadarso, Vigo, J. A. Cristbal,
Zaragoza, J. Ferro, Gasteiz-Vitoria, Spain; and
A. F. Smith, Nuffield Laboratory of Ophthalmology, University of
Oxford, Oxford and Alcon Laboratories, United Kingdom.
329