Two year results: Sharp versus rounded

optic edges on silicone lenses

Andreas J. Kruger, MD, Jörg Schauersberger, MD, Claudette Abela, MD,
Gebtraud Schild, MD, Michael Amon, MD

ABSTRACT
Purpose: To evaluate the role of optic edge design of 2 silicone intraocular lenses (IOLs) in
2 year clinical results.

Setting: Department of Ophthalmology, University of Vienna, Medical School, Allgemeines

Krankenhaus, Austria.

Methods: In this comparative clinical study, 50 eyes had phacoemulsification and

implantation of a high-refractive 3-piece silicone IOL with sharp optic edges
(CeeOn™ model 911F) (n ⫽ 25) or a 3-piece silicone lens with rounded optic edges
(CeeOn™ model 920) (n ⫽ 25). Biomicroscopic findings, including those of specular
microscopic examination of the anterior lens surface, were documented and the
results analyzed.

Results: After 2 years, a significant between-group difference in posterior capsule

opacification (PCO) but not in anterior capsule alterations was observed. Behind all
CeeOn 911F sharp-edge IOLs, the capsule remained clear; in 2 of 23 capsules
behind the CeeOn 920 rounded-edge, a neodymium: YAG laser capsulotomy had to
be performed for dense central fibrotic PCO. Seven of 21 of the remaining eyes had
first-degree central fibrotic PCO, 14 of 23 had peripheral mixed fibrotic and slender
Elschnig pearl PCO, and 8 of 23 had second-degree peripheral PCO. Specular
microscopic findings did not differ between the 2 groups. No severe IOL decentra-
tion occurred in any eye; 25% in the sharp-edge group and 40% in the rounded-
edge group had minimal decentration.

Conclusion: The silicone IOL with the sharp optic edge design was associated with
significantly reduced PCO 2 years postoperatively. J Cataract Refract Surg 2000;
26:566 –570 © 2000 ASCRS and ESCRS

trast, Ursell et al.2 suggest that PCO may be material

P oly(methyl methacrylate) (PMMA) intraocular
lenses (IOLs) with sharp optic edges and the Acry-
Sof威 lens are reported to reduce the incidence of poste-
rior capsule opacification (PCO).1,2 Nishi and Nishi1
state that IOL material appears to play a minor role in
PCO and that design is a major determinant. In con-
Accepted for publication December 20, 1999.
Reprint requests to A.J. Kruger, MD, Department of Ophthalmology,
University of Vienna, Medical School, Allgemeines Krankenhaus, Währ-
inger Gürtel 18-20, A-1090 Vienna, Austria.
© 2000 ASCRS and ESCRS
Published by Elsevier Science Inc.
dependent.
In spring 1997, a multicenter phase IIIa study of
a new high-refractive 3-piece silicone IOL was
started. This IOL, the CeeOn™ model 911F, had a
new haptic design and material and its optic edges
were sharp. To evaluate the role of silicone IOL edge
design on biocompatibility and performance, a com-
parative study with a similar 3-piece silicone IOL
with rounded edges was performed. The 2 year results
are presented.
0886-3350/00/$–see front matter
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 SILICONE LENSES: SHARP VERSUS ROUNDED OPTIC EDGES
Patients and Methods
After approval from the Ethics Committee of the
Vienna University School of Medicine and written in-
formed patient consent were obtained, 50 patients with
senile cataract were studied. The inclusion criteria were
age 50 years or older, the potential to achieve 20/40
visual acuity, and no ocular pathology other than cata-
ract. Patients with uncontrolled glaucoma, proliferative
diabetic retinopathy, corneal pathology, previous in-
traocular surgery or a history of uveitis, and those taking
systemic anti-inflammatory medication were excluded.
Patients received either a CeeOn model 911F (n ⫽
25) or a CeeOn model 920 (n ⫽ 25) (Pharmacia &
Upjohn) IOL. Both are 3-piece and biconvex with an
optic diameter of 6.0 mm. The specifications of the
CeeOn 911F/CeeOn 920 were as follows: an overall
diameter of 12.0 mm/12.5 mm, a loop angulation of 6
degrees/5 degrees, haptics of polyvinylidene fluoride
(PVDF)/PMMA, and a refractive index of 1.46/1.43.
The 911F has sharp optic edges and the model 920,
rounded optic edges.
As participation in another clinical trial (CeeOn
Edge phase IIIa study) was permitted, it was not possible
to implant the 2 IOLs in the fellow eyes of the patients.
Therefore, the 2 IOLs were alternatively and consecu-
tively implanted in patients who had had cataract sur-
gery as in-patients.
Pupils were dilated before surgery by applying the
following eyedrops 3 times: tropicamide (Mydriaticum
Agepha威), cyclopentolate 1% (Thilo威), and phenyleph-
rine 1% and diclofenac 1% (Voltaren Ophtha威). Oral
or peribulbar steroids or drugs that cause pupil dilation
were not used. Fortified balanced salt solution (BSS
Plus威) with 40 mg/500 mL gentamicin (Refobacin威)
and adrenaline (Suprarenin威) (0.5 mL/500 mL) were
applied as an intraocular infusion.
All surgeries were performed by an experienced sur-
geon (M.A.) after administration of peribulbar anesthe-
sia of 2.5 mL lidocaine 2% plus 2.5 mL bupivacaine
0.5%. After a shallow groove of about 400 ␮m was
made, a 3-plane clear corneal incision was performed
using a temporal approach and a 3.2 mm bevel-up steel
lance. The paracentesis was done at the 4 or 7 o’clock
position depending on the eye. The rest of the procedure
was standardized and consisted of the following: (1) a
well-centered continuous curvilinear caspulorhexis,
J CATARACT REFRACT SURG—VOL 26, APRIL 2000
about 5.0 mm, made with a bent 24 gauge cannula
under sodium hyaluronate (Healon威); (2) hydrodissec-
tion and hydrodelineation with BSS Plus; (3) bimanual
divide and conquer phacoemulsification in the capsular
bag; (4) bimanual aspiration or removal of cortical lens
material and capsule polishing with the irrigation/aspi-
ration tip; (5) delineation of the capsular bag and ante-
rior chamber with Healon; (6) IOL implantation in the
bag using a folder after the incision was minimally ex-
tended to both sides; (7) complete removal of Healon,
especially behind the IOL, followed by filling the ante-
rior chamber with BSS Plus; (8) no-stitch wound
closure.
A dressing with betamethasone and neomycin oint-
ment (Betnesol N威) was placed on all eyes overnight.
Postoperatively, Betnesol N and Voltaren Ophtha eye-
drops were applied 4 times a day. The postoperative
topical medication was discontinued after 4 weeks.
At the 2 year follow-up visit (range 21 to 25
months), biomicroscopic analysis, including specular
microscopic examination of the anterior IOL surface,
was performed. Intraocular lens decentration was semi-
quantitatively graded as follows: 0 ⫽ none; 1 ⫽ 0 to
0.25 mm; 2 ⫽ 0.25 to 0.50 mm; 3 ⫽ 0.50 to 1.00 mm;
4 ⫽ more than 1.00 mm.
On the anterior surface of the IOL, small round and
spindle-shaped cells were graded as follows: 0 ⫽ none;
1 ⫽ fewer than 10; 2 ⫽ 10 to 25; 3 ⫽ more than 25. In
addition epithelioid and foreign-body giant cells were
counted, and lens epithelial cells (LECs) were graded
semiquantitatively in each quadrant of the capsule-free
portion of the optic.3
For examination, the anterior capsule leaf was di-
vided into a capsulorhexis rim area and a capsule/optic
area. Anterior capsule opacification (ACO) was graded
as 0 ⫽ absent; 1 ⫽ very mild; 2 ⫽ moderate; 3 ⫽ dense
white. The capsule behind the optic was evaluated
within a central area measuring 3.0 mm in diameter and
in the periphery. A distinction was made between fibro-
sis and Elschnig regenerates; that is, between flat and
pearl formation. Each form of PCO, fibrosis and
Elschnig regenerates, was graded semiquantitatively
from 0 to 3.
Results
Of the 50 patients, 45 were still available for a 2 year
follow-up visit: 22 in the CeeOn 911F (sharp-edge)
567
 SILICONE LENSES: SHARP VERSUS ROUNDED OPTIC EDGES

Table 1. Patient demographics and mean IOL power. group and 23 in the CeeOn 920 (rounded-edge) group.
Group
Three patients died between the 1 and 2 year follow-up:
2 in the sharp-edge and 1 in the rounded-edge group.
CeeOn CeeOn
911F* 920† Both Two patients were in poor physical condition and were
(N ⴝ 22 (N ⴝ 23 (N ⴝ 45
Characteristic eyes) eyes) eyes)
unable to travel to the study site.
Both groups were comparable in terms of age, sex,
Age (years)
location of cataract (left or right eye), and mean IOL
Mean ⫾ SD 73.4 ⫾ 8.07 74.8 ⫾ 7.41 74.2 ⫾ 7.7
power (Table 1).
Range 54.3–85.9 62.5–88.4 54.3–88.4
Table 2 shows the ACO, PCO, and IOL decentra-
Eye
tion results. There were no significant differences in the
Left 10 14 24 anterior capsule behavior or IOL centration between the
Right 12 9 21 2 groups.
Sex Fibrosis in the area of contact between anterior and
Male 7 7 14 posterior capsules was detected in 5 eyes in the rounded-
Female 15 16 31 edge group; 2 had total capsular capture. Six in the
IOL Power (D) sharp-edge group had capture, 2 total. Six eyes in the
Mean ⫾ SD 21.9 ⫾ 1.3 22.4 ⫾ 2.4 22.2 ⫾ 2.1 sharp-edge group had peripheral fibrotic PCO. In all
*Sharp edge cases, when the anterior and posterior capsule leaves
†
Rounded edge came into contact, fibrotic transformation was initiated.

Table 2. Two year results of ACO, PCO, and IOL decentration by number of eyes.

CeeOn 911F* CeeOn 920†

(n ⴝ 22 eyes) (n ⴝ 23 eyes)
Grade‡ Grade‡
Result 0 1 2 3 0 1 2 3

Anterior capsule
opacification
Rim 1 2 14 5 0 2 20 0
Capsule/optic 0 17 5 0 0 15 8 0
Posterior capsule
opacification
Center 22 0 0 0 13 7 1 2
Fibrosis 0 0 0 0 0 3 0 2
Elschnig 0 0 0 0 0 2 0 0
Mixed 0 0 0 0 0 2 1 0
Periphery 16 6 1 0 1 14 8 0
Fibrosis 0 6 1 0 0 5 4 0
Elschnig 0 0 0 0 0 6 3 0
Mixed 0 0 0 0 0 3 1 0
IOL decentration 17 5 0 0 12 9 2 0
*Sharp edge
†
Rounded edge
‡
Anterior and posterior capsule opacification: 0 ⫽ absent, 1 ⫽ very mild, 2 ⫽ moderate, 3 ⫽ dense; IOL decentration: 0 ⫽ none, 1 ⫽ 0 – 0.25 mm,
2 ⫽ 0.25– 0.50 mm, 3 ⫽ 0.50 –1.00 mm

568 J CATARACT REFRACT SURG—VOL 26, APRIL 2000

 SILICONE LENSES: SHARP VERSUS ROUNDED OPTIC EDGES
All other posterior capsules in this group remained clear,
including in the periphery.
No epithelioid or multinucleated cells were found
on the anterior IOL surface in either group. Small round
and spindle-shaped cells (grade 1, fewer than 10 cells)
were detected by specular microscopy in 2 eyes in the
rounded-edge group and in 5 in the sharp-edge group.
Discussion
The formation of PCO might be influenced by
postoperative inflammation and the latter, by incision
size.4 All lenses in this study were inserted in a folded
fashion through a minimally widened incision. There-
fore, factors related to incision size do not apply.
In an animal study in which an AcrySof IOL was
implanted in 1 eye and a PMMA IOL of the same shape
in the contralateral eye, Nishi and Nishi1 demonstrated
that LEC migration was inhibited at the sharp optic
edges. They suggest that IOL design is a major factor
and that material appears to play a minor role.
Comparing a 3-piece PMMA IOL, silicone IOL,
and AcrySof IOL, Ursell et al.2 found it unlikely that
differences in lens design would be sufficient to account
for such dramatic differences in PCO rates, referring to
the low incidence of PCO with the AcrySof IOL and its
sharp optic edge.
Our results differ from those of Ursell et al.2 and
confirm those of Nishi and Nishi,1 although we are
aware of the limitations of our study. The slightly dif-
ferent haptic angulation and design and the IOL mate-
rial appear to have had no major effect on IOL
performance after 2 years. However, the different refrac-
tive index of the 2 materials and the resultant lower
mean central thickness of the optics of the CeeOn 911F
undermine the strength of our findings. That we were
unable to implant the IOL in the contralateral eyes of
patients may have been a major cause of the different
results of our study.
Both groups had a similar rate of capsular capture
phenomena, which was partly because the initial capsu-
lorhexis was too large and not ideally centered. To avoid
this “slipping down” of the anterior capsule leaf from the
optics, it appears essential to keep the capsulorhexis size
to less than 5.0 mm and to ensure exact centralization.
This should help prevent peripheral fibrosis in the re-
gion of contact between the anterior and posterior cap-
J CATARACT REFRACT SURG—VOL 26, APRIL 2000
sule leaves and to minimize the risk of decentration.5
Capsular capture is a well-known complication of
3-piece silicone and of PMMA IOL implantation; how-
ever, PMMA has a lower incidence.6,7
The haptic materials (PMMA CeeOn 920; PVDF
CeeOn 911F) appear to be equivalent in terms of cen-
tration behavior; no major decentration occurred in ei-
ther group. The results of the model 920 in this respect
are similar to data reported by Linnola and Holst.8
Cell deposits on the IOL surface after 2 years is a
manifestation of inflammation induced by the foreign
body (i.e., the IOL). Small round or spindle-shaped cells
were found in about 10% of IOLs in both groups. One
hundred eight days after surgery, Ravalico and coau-
thors9 found fewer than 10 cells/mm2 on the anterior
lens surface of the silicone IOL in 10% of eyes. In a study
comparing PMMA, silicone, and AcrySof IOLs, Hollick
and coauthors10 found that the silicone group had the
highest mean cell grades throughout the 2 year follow-
up; however, 2 years after surgery, the average small-cell
grade was zero in all 3 groups.
We found no epithelioid cells or multinucleated
foreign-body cells 2 years after surgery. These findings
are consistent with those of Ravalico and coauthors9
6 months after surgery, Linnola and Holst8 at 12
months, and Hollick and coauthors10 at 720 days. The
reason for the low foreign-body reaction might have
been the in-the-bag position of the IOLs, postoperative
administration of steroidal and nonsteroidal anti-in-
flammatory eyedrops, and the exclusion of eyes at risk
for severe postoperative inflammation (e.g., uveitic
eyes). In contrast, Amon and Menapace11 reported a
rate of 9.4% foreign-body giant cells on 3-piece silicone
IOLs after a mean follow-up of 7.3 months. They used a
scleral tunnel incision. Eighteen percent of this cell re-
action was on silicone disk lenses. They believe that the
IOL’s hydrophobic surface properties and shape are re-
sponsible for their findings.
Specular microscopic examination failed to demon-
strate visible LEC growth on the anterior surface of the
IOL beyond the capsulorhexis rim in any patient. This is
consistent with the surface cytologic findings of Hollick
and coauthors12 360 days after surgery.
Nearly all IOLs in both groups showed marked
whitening of the capsulorhexis margin as well as the
anterior capsular leaf. This is a well-known phenome-
non in eyes with silicone lenses.13 The whitening,
569
 SILICONE LENSES: SHARP VERSUS ROUNDED OPTIC EDGES
mainly of the capsulorhexis rim, may prevent or reduce
the intensity of edge-glare phenomenon, despite the
sharp optic edges of the CeeOn 911F.14
No discoloration was observed in any IOL, al-
though the sharp-edge 911F IOL had homogeneous mi-
crovacuoles throughout, similar to those observed on
other high-refractive IOLs (e.g., Allergan SI-40).
In our study, neodymium: YAG laser capsulotomy
had to be performed because of central fibrotic PCO in
2 eyes (6.9%) in the rounded-edge group. Milazzo and
coauthors15 reported a capsulotomy rate of 13.7% after
3 years (average 20 months) and Cumming,16 7.1%
with a follow-up of 12 months. Both studies used a
3-piece silicone IOL. In a study in which Linnola and
Holst implanted CeeOn model 920 IOLs, a capsulot-
omy had to be performed in 11% of eyes after a fol-
low-up of 12 months.8
Conclusion
Both silicone IOL models showed excellent uveal
biocompatibility (cell reaction on the surface). The
markedly reduced PCO with the 911F (sharp-edge)
IOL appears to be mainly related to its design. Observa-
tion will show whether this edge phenomenon is effec-
tive over the long term. Implantation of silicone lenses of
the same material but different optic design in contralat-
eral eye might shed more light on our findings.
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From the Department of Ophthalmology, University of Vienna, Medical
School, Allgemeines Krankenhaus, Vienna, Austria.
Presented at XVIIth Congress of the European Society of Cataract &
Refractive Surgeons, Vienna, Austria, September 1999.
None of the authors has a financial interest in any product mentioned.