Intraocular lens centration and visual outcomes after bag-in-the-lens implantation.

Abstract

To examine the centration and visual outcomes after cataract surgery using the bag-in-the-lens (BIL) implantation technique.
University Hospital Antwerp, Department of Ophthalmology, Edegem, Belgium.
This study comprised 180 eyes of 125 patients who had cataract surgery with implantation of the BIL intraocular lens (IOL) between March 2002 and September 2005. Postoperative data at 5 weeks, 6 months, and 1 year were evaluated. The geometric center of the IOL, measured on a red reflex slitlamp photograph, was compared with the geometric center of the pupil and the limbus.
The mean decentration compared with the limbus was 0.304 mm+/-0.17 (SD) at a mean angle of -24.9+/-113.3 degrees. Compared with the dilated pupil, the mean deviation was 0.256+/-0.15 mm at a mean angle of -5.2+/-119.0 degrees. The amount of decentration was stable during the postoperative follow-up period. There was no correlation between the amount of decentration and the visual outcomes (pupil: r=-0.07, P=.494; limbus: r=0.11, P=.304).
Surgeon-controlled BIL centration was predictable 5 weeks and unchanged 6 months and 1 year postoperatively. It can therefore be concluded that capsular bag healing has no influence on BIL IOL centration over time.

Full text

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Intraocular lens centration and visual outcomes
after bag-in-the-lens implantation
Kristien H.M. Verbruggen, MD, Jos J. Rozema, PhD, Laure Gobin, PhD, Tanja Coeckelbergh, PhD,
Veva De Groot, MD, PhD, Marie-Jose ´ Tassignon, MD, PhD, FEBO
PURPOSE: To examine the centration and visual outcomes after cataract surgery using the bag-in-
the-lens (BIL) implantation technique.
SETTING: University Hospital Antwerp, Department of Ophthalmology, Edegem, Belgium.
METHODS: This study comprised 180 eyes of 125 patients who had cataract surgery with implan-
tation of the BIL intraocular lens (IOL) between March 2002 and September 2005. Postoperative
data at 5 weeks, 6 months, and 1 year were evaluated. The geometric center of the IOL, measured
on a red reflex slitlamp photograph, was compared with the geometric center of the pupil and the
limbus.
RESULTS: The mean decentration comparedwith the limbus was 0.304 mm G 0.17 (SD)at a mean
angleof?24.9G113.3degrees.Comparedwiththedilatedpupil,themeandeviation was0.256G
0.15 mm at a mean angle of ?5.2 G 119.0 degrees. The amount of decentration was stable during
the postoperative follow-up period. There was no correlation between the amount of decentration
and the visual outcomes (pupil: r Z ?0.07, P Z .494; limbus: r Z 0.11, P Z .304).
CONCLUSIONS: Surgeon-controlled BIL centration was predictable 5 weeks and unchanged
6 months and 1 year postoperatively. It can therefore be concluded that capsular bag healing
has no influence on BIL IOL centration over time.
J Cataract Refract Surg 2007; 33:1267–1272 Q 2007 ASCRS and ESCRS
Many intraocular lens (IOL) designs have been
developed since Ridley’s original model in 1949.1,2
The conventional IOL implantation technique consists
of inserting theIOLinthe capsularbag, which is called
the lens-in-the-bag (LIB) implantation technique (Fig-
ure 1, A). This method inevitably leads to a large
area of contact between the IOL biomaterial and cap-
sular bag. The capsular bag response, described as
a foreign-body reaction of lens epithelial cells (LECs)
against the IOL biomaterial, results in the stimulation
of LECs lying at the surface of the anterior capsule,
causing anterior capsule opacification (ACO), and of
equatorial LECs, causing posterior capsule opacifica-
tion (PCO).
Posterior capsule opacification can be very mild or
severe according to the biomaterial. In cases of severe
PCO, patients have a reduction in visual acuity, which
can be treated by a neodymium:YAG (Nd:YAG) laser
capsulotomy. The lowest Nd:YAG laser capsulotomy
rates found in the literature reach 10.4% 5 years after
surgery.3
A bag-in-the-lens (BIL) IOL (model 89A, Morcher)
was introduced in 2000. Since 2004, the Belgian
National Health Service has reimbursed for this IOL,
which is routinely implanted at our department. The
BIL IOL consists of a central optic surrounded by
a groove defined by 2 oval haptics perpendicularly
oriented to each other (Figure 1, B).4
Accepted for publication March 4, 2007.
From the Department of Ophthalmology, University Hospital,
Antwerp, Belgium.
Dr. Tassignon has a proprietary interest in the intraocular lens and
ring caliper used as described under patent US 6,027,531. No other
author has a financial or proprietary interest in any material or
method mentioned.
R. Leysen provided photographic assistance.
Corresponding author: Prof. Dr. M.J. Tassignon, University Hospi-
tal Antwerp, Department of Ophthalmology, Wilrijkstraat 10, 2650
Edegem, Belgium. E-mail: marie-jose.tassignon@uza.be.
Q 2007 ASCRS and ESCRS
Published by Elsevier Inc.
0886-3350/07/$dsee front matter 1267
doi:10.1016/j.jcrs.2007.03.022
ARTICLE

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The new BIL implantation technique is designed to
solve the problem of PCO based on the principle of
capturing the remaining LECs in the equatorial space
andprohibitingtheirproliferation.4–7Clinicalobserva-
tions showed that after BIL IOL implantation, ACO
does not occur, which can only be explained by the
lack of transformation of the anterior capsule LECs
into fibroblasts or myofibroblasts.4–7
The efficacy of the BIL implantation in terms of PCO
was studied in 100 eyes with a follow-up ranging from
7 months to 6 years.7Because the biomaterial used to
manufacturetheBILisahydrophilicacrylicwithawa-
ter content of approximately 24%, postoperative uveal
response is expected to be very low.4,6
Thering caliper (Figure2,A) wasintroduced in2005
to facilitate sizing and centration of the anterior capsu-
lorhexis along the alignment of the first and third Pur-
kinje reflexes,observedunder the microscope.8For the
purpose of BIL implantation, the ring has an internal
diameter of 5.0 mm.
Before the introduction of the ring caliper, we used
astickcaliper8(Duckworth&Kent)toprint3reference
points on the surface of the anterior capsule. The dis-
tancebetweenthe2outerpointsis4.5mm(Figure2,B).
Because of good capsule and uveal biocompatibility
of the BIL implantation technique, it has been specu-
lated that the capsular bag maintains its physiological
properties, which prevents IOL decentration over
time. To confirm this hypothesis, we investigated the
stability of the BIL IOL over time by evaluating the
centration(translationalstability)andvisualoutcomes
after implantation.
PATIENTS AND METHODS
The 125 patients in this study had phacoemulsification and
IOL implantation between March 2002 and September
2005.The availabilityof postoperativered-reflex
photographs at 5 weeks, 6 months, and 1 year determined
patient selection. The SRK/T formula with an A-constant
of 118.2 was used to calculate the IOL power.
All surgeries were performed by 1 of 2 surgeons (T.M.J.,
D.G.V.) following a standard previously described proce-
dure.4,6,7Most patients were operated on under topical and
intracameral lidocaine anesthesia.
At each postoperative examination, the best corrected dis-
tance visual acuity (decimal chart), objective refraction, and
red-reflex slitlamp photographs were recorded. Only eyes
with no ocular comorbidity besides cataract (n Z 104)
were used in the evaluation of visual outcomes.
The position of the geometric center of the IOL was ana-
lyzedwithrespecttothegeometriccenterofthedilatedpupil
and the limbus on digital photographs by the same observer
(K.V.) using a program written in MathLab 6.5 (The Math-
Works). The first ellipse is drawn following the contours of
the IOL optic, and the second is drawn following the border
Figure2.A:Anteriorcapsulorhexisperformedusingtheringcaliper.
B: Anterior capsulorhexis performed using the stick caliper.
Figure 1. A: Schematic drawing of a side view of LIB IOL implanta-
tion. B: Schematic drawing of a side view of BIL IOL implantation.
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of the pupil or of the limbus. The computer calculated the
shift between the 2 geometric centers (Figure 3).
Descriptive statistics (patient age and sex, IOL power,
postoperative follow-up, postoperative best corrected visual
acuity [BCVA], IOL decentration) were analyzed using SPSS
12.0for Windows(SPSS, Inc). Normality ofthe datadistribu-
tion wasconfirmed using the Kolmogorov-Smirnov test. The
Pearson correlation coefficient (r) was calculated to test the
relationship between the pupil and limbus and between
IOL decentration and visual acuity. Decentration over time
was tested with the general linear model (GLM) repeated
measures. Intraobserver and interobserver reproducibility
were tested with the coefficient of variation and the GLM re-
peated measures. The t test was used to compare decentra-
tion with the stick caliper and the ring caliper. A P value
less than 0.05 was considered statistically significant.
Statistical comparison with other studies was performed
with the z test.
RESULTS
The mean age of the patients (66 women, 59 men) at
the time of surgery was 68.1 years G 14.1 (SD). The
mean IOL power was C20.2 diopters (D) (range
?3.0 to C31.0 D).
The mean preoperative BCVA (decimal) in healthy
eyes without ocular comorbidity was 0.5 G 0.2. The
mean postoperative BCVA improved to 1.0 G 0.1,
which corresponds to 97.9% of healthy eyes achieving
a postoperative visual acuity of 1.0 or better.
Figure 4 shows the amount of decentration of the
geometric center of the IOL optic with respect to the
x-axis and y-axis of a 2-dimensional Cartesian system
(the coronal plane). The measurements at last visit
showed a mean IOL deviation of 0.256 G 0.15 mm at
an axis of ?5.2 G 119.0 degrees with respect to
the dilated pupil and a mean deviation of 0.304 G
0.17 mm at an axis of ?24.9 G 113.3 degrees with
respect to the limbus. Significantly less decentration
was found when IOL decentration was evaluated
withrespecttothepupilthanwithrespecttothelimbus
(GLM: Pillai’s trace Z 0.32, F(1,47)Z 21.6; P Z .001).
However, when looking at each eye separately, decen-
tration of the pupil and that of the limbus were poorly
correlated(rZ0.65;PZ.001;R2Z0.42),meaningthat
1 measurement was significative for the prediction of
the other (mean difference 0.05 G 0.15 mm).
No decentration exceeded 0.8 mm. The maximum
deviation with respect to the limbus was 0.785 mm.
Decentration with respect to pupil at last visit
0,8
-0,8
-0,6
-0,4
-0,2
0
0,2
0,4
0,6
-0,8-0,6 -0,4 -0,20,2 0,4 0,60,8
Decentration versus X-axis (mm)
Decentration versus Y-axis (mm)
TN
0
A
Decentration with respect to limbus at last visit
0,8
-0,8
-0,6
-0,4
-0,2
0
0,2
0,4
0,6
-0,8-0,6-0,4-0,2 0,20,4 0,60,8
Decentration versus X-axis (mm)
B
Decentration versus Y-axis (mm)
TN
0
Figure 4. A and B: Decentration of the BIL at last visit with respect to
thegeometricalcenterofthedilatedpupilandthegeometricalcenter
ofthelimbusplottedonaCartesiancoordinatesystem.Theresulting
oblique value is expressed in millimeters and the direction of the de-
centration, in degrees. The mean decentration is shown in red, with
one standard deviation for the x-axis values and y-axis values sepa-
rately. In both eyes, the positive values on the x-axis point nasally in
the eye.
Figure 3. The blue ellipsis follows the contours of the IOL optic, the
green ellipsis follows the border of the pupil, and the red ellipsis
follows the border of the limbus. The shift between the geometric
centers (IOL–pupil and IOL–limbus) is calculated.
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With reference to the pupil, the largest decentration
measured was 0.795 mm (Figure 5). No significant cor-
relation between decentration and visual outcomes
was established (pupil: r Z ?0.07, P Z .494; limbus:
r Z 0.11, P Z .304).
The mean postoperative decentration at 5 weeks
(112 eyes), 6 months (91 eyes), and 1 year or longer
(59 eyes) was similar (Table 1, A). A comparison of de-
centration in15eyes forwhich theconsecutive datafor
each follow-up time were available showed no statisti-
cally significant difference between the position of the
IOL at 5 weeks, 6 months, or 1 year postoperatively
(GLM pupil: Pillai’s trace Z 0.124, F(2,28) Z 1.03,
P Z .372; limbus: Pillai’s trace Z 0.003, F(2,28)Z 0.04,
P Z .965) (Table 1, B).
Performing the anterior capsulorhexis with the help
of the stick caliper or the ring caliper did not result in
a significant difference in the degree of decentration
(Table 2) (pupil: t(187)Z 0.51, P Z .609; limbus: t(187)
Z 0.97; P Z .335). To confirm the validity of the
method for measuring decentration, intraobserver re-
producibility and interobserver reproducibility were
calculated. To obtain intraobserver repeatability, the
coefficient of variation, which was 3% for the pupil
measurements and 6% for the limbal measurements,
was calculated. The error for a mean decentration of
0.3 mm was 0.015 mm and 0.024 mm, respectively,
which is negligible. Furthermore, the GLM repeated
measures showed no significant difference between
the measurements of decentration made by 2 ob-
servers with respect to the pupil and limbus (PO.05
for all) (Pillai’s trace Z 0.054, F(1,47)Z 2.7, P Z .107).
It was concluded that both intraobserver and interob-
server reproducibility were acceptable.
DISCUSSION
Many techniques topreventPCOhave been proposed.
A recent method, optic capture, was first described by
Gimbel and DeBroff,9Vasavada and Desai,10Raina
et al.,11and Grieshaber et al.12for pediatric cataract
surgery and was introduced by Menapace13for rou-
tine cataract surgery in adults.
More recently, the BIL IOL was designed to insert
both the anterior capsule and the posterior capsule in
the lens groove defined by both IOL haptics after an
anterior capsulorhexis and posterior capsulorhexis of
the same size are created. The main benefit of this im-
plantation technique is that it blocks LEC reprolifera-
tion within the optical axis over time.4–8
To study the translational stability of the BIL
IOL over time, we evaluated its centration with
respect to the pupillary and limbal centers. The mean
Table 1A. Postoperative IOL decentration over time in relation to the pupil and the limbus.
Mean Decentration (mm) G SD
Parameter5 Weeks (112 Eyes) 6 Months (91 Eyes)
R12 Months (59 Eyes)
With respect to pupil
With respect to limbus
0.236 G 0.129
0.278 G 0.162
0.289 G 0.169
0.328 G 0.173
0.239 G 0.127
0.311 G 0.171
Table 1B. Postoperative IOL decentration over time in relation to the pupil and the limbus in the 15 eyes with consecutive measurements.
Mean Decentration (mm) G SD
Parameter5 Weeks6 Months
R12 Months GLM Repeated Measures
With respect to pupil
With respect to limbus
0.256 G 0.107
0.293 G 0.174
0.246 G 0.132
0.290 G 0.171
0.223 G 0.115
0.285 G 0.175
F(2,28)Z 1.03*
F(2,28)Z 0.04*
GLM Z general linear model
*No significant difference between decentration at 5 weeks, 6 months, 12 months or longer
0
0.05 - 0.099
5
10
15
20
25
30
0.00 - 0.049
0.1 - 0.149
0.15 - 0.199
0.2 - 0.249
0.25 - 0.299
0.3 - 0.349
0.35 - 0.399
0.4 - 0.449
0.45 - 0.499
0.5 - 0.549
0.55 - 0.599
0.6 - 0.649
0.65 - 0.699
0.7 - 0.749
0.75 - 0.799
0.8 - 0.849
0.85 - 0.899
Decentration at last visit (mm)
Number of eyes
Decentration with respect to pupil Decentration with respect to limbus
n = 180
Figure 5. Decentration (nasal or temporal) of the BIL IOL with re-
spect to the dilated pupil and the limbus.
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decentration of the BIL IOL with respect to the pupil
was 0.256 G 0.15 mm at an axis of ?5.2 degrees (nasal
side). With respect to the limbus, the mean decentra-
tion was 0.304 G 0.17 mm at an axis of ?24.9 degrees
(nasal side). Postoperative follow-up did not signifi-
cantly influence decentration, suggesting the BIL IOL
remains in a stable position over time.
Because of the physiological angle k, slightly nasal
decentration of the anterior capsulorhexis was the
goal during surgery.14,15When considering this angle
k, the mean decentration was reduced to 0.076 mm
with respect to the pupil and 0.124 mm with respect
to the limbus. (The 5-degree angle k corresponds to
0.18 mm of nasal decentration in the Gullstrand eye.)
We could not establish a significant correlation
between decentration and visual acuity. Hayashi
et al.16did not find a significant correlation with
monofocal IOLs either; however, they state that ‘‘in
multifocal IOLs, distal visual acuity significantly de-
creaseswhendecentrationis0.7mmormore.’’Guyton
et al.17report that IOL decentration of more than
1.0 mm could impair visual quality.
The BIL implantation technique offers the surgeon
the ability to position the BIL IOL in a surgeon-con-
trolled manner. To facilitate correct sizing of the ante-
rior capsulorhexis and the position of the IOL
according to the first and third Purkinje reflexes, ob-
served through the surgical microscope, we studied
BIL IOL centration before and after the use of the
ring caliper. There was no significant difference be-
tween the 2 calibration techniques.
Finally, we compared the results in this study with
those in other studies of acrylic IOLs18–24(Table 3). Ex-
cept for Mutlu et al.,18all results in the literature were
gathered using Scheimpflug imaging. The difference
in mean decentration between the other studies and
our study is expressed as a z score. A negative z score
means that the other study had worse centration than
our study. A positive z score represents better centra-
tion in the other study than in our study (z score O
G1.96 Z significant). Table 3 shows better centration
for the BIL IOL. However, the results should be in-
terpreted with caution because the methods of mea-
suringdecentration are
technology has the advantage of measuring IOL cen-
tration along the visual axis, which is more physiolog-
ical than using the geometric center of the limbus or
the pupil.
This study confirmed our clinical assumption that
the BIL IOL remains stable once positioned in the
eye. This is a major issue to achieve before implanting
toric or multifocal IOLs.
different. Scheimpflug
Table 3. Literature overview of decentration of acrylic IOLs compared to the BIL IOL. The difference in mean decentration between that in
the literature and that in the present study is expressed as a z score.
Z Score†
Study*
Mean Decentration
(mm) G SDAcrylic IOL
Mean Time
After Surgery (Mo)
Decentration with
Respect to Pupil
Decentration with
Respect to Limbus
Mutlu18
Tatekani19
Kim20
Hayashi21
Tatekani22
Hayashi23
Hayashi24
0.34 G 0.08
0.42 G 0.19
0.33 G 0.19
0.31 G 0.15
0.30 G 0.17
0.28 G 0.16
0.24 G 0.18
AcrySof SA30AL
AcrySof MA30BA
AcrySof MA60BM
AcrySof MA60BM
AcrySof MA30BA
AcrySof MA60BM
AcrySof SA30AL
26.7 G 4.4
7.5 G 1.4
6
12
16.7 G 14.4
6
6
?1.1
?0.9
?0.4
?0.4
?0.3
?0.2
C0.1
?0.5
?0.6
?0.2
?0.1
?0.0
C0.1
C0.3
*First author only
†A negative z score means that the decentration was higher than in our study; a positive z score means that the decentration was lower than in our study.
Table 2. Postoperative IOL decentration over time with the stick caliper and the ring caliper with respect to the pupil and limbus.
Mean Decentration (mm) G SD
ParameterWith Stick Caliper (105 Eyes)With Ring Caliper (84 Eyes)
t Test
With respect to pupil
With respect to limbus
0.256 G 0.144
0.326 G 0.170
0.245 G 0.159
0.302 G 0.173
t(187)Z 0.51*
t(187)Z 0.97*
*No significant difference between the use of the stick caliper or the ring caliper
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First author:
Kristien H.M. Verbruggen, MD
Department of Ophthalmology, University
Hospital, Antwerp, Belgium
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