case reports

Cataract development after implantation

of the Staar Collamer posterior chamber
phakic lens
Andrew M. Fink, FRCOphth, Christa Gore, MSc, MCOptom,
Emanuel Rosen, MD, FRCSE

ABSTRACT
Implantation of a posterior chamber phakic intraocular lens is an effective refractive
procedure with a good safety record in the short-term follow-ups reported !n the
literature, Cataract formation is a potential complication of the procedure. Two
patients developed lens opacities in 3 eyes after the procedure was performed for
myopic astigmatism. The possible causes are discussed. This is not a dangerous
complication as cataract extraction is easily achieved if necessary. However, it is
undesirable and further research is required to assess the long-term incidence,
causes, and ways to prevent its occurrence. J Cataract Refract Surg 1999; 25:278-
282

" mplantation of a phakic intraocular lens (IOL) is an
l .attractive solution to correct refractive errors in
many cases. Corneal techniques such as photorefractive
keratectomy (PRK) and laser in situ keratomileusis
(LASIK) are unreliable for high refractive errors.
Photorefractive keratectomy in particular is prone to
unpredictable healing responses and is an uncomfort-
able procedure for patients. With the exception of
intrastromal rings, all corneal refractive interventions
are irreversible.
In contrast, refractive correction with phakic IOLs
is predictable even in eyes with high refractive errors.
The procedure is patient friendly, with little discomfort
and rapid visual rehabilitation, and it is reversible.
However, entering the eye, even with the safe, mini-
mally invasive techniques in routine cataract surgery, is
still not hazard free. Rare instances of inflammation
and hemorrhage are well recognized and may appear
during or soon after the operation. Other complica-
tions may appear later. Particularly in relation to new
techniques such as phakic lens implantation, long-term
follow-up is essential.
We report 2 patients who had refractive correction
for high myopic astigmatism with the implantation of
the Staar Collamer posterior chamber phakic IOL,
TM

also known as the implantable contact lens (ICL). Both

Acceptedfor publication October 17, 1998.
developed cataract postoperatively.
From the Centre for Advanced R~Cractive Eye Surgery, Alexandra
Hospita£ Cheadle, Manchester, United Kingdom.
None of the authors has a financial or proprietary interest in any Case 1
material or method mentioned.
A 40-year-old female physician presented for refractive
Reprint requests to Mr. E. Rosen, 10 St. John Street, Manchester, surgery. She had no history of diabetes or other systemic
M3 4DY, United Kingdom. disease. She denied having had ocular inflammation, trauma,

278 J CATARACT REFRACT SURG--VOL 25, FEBRUARY 1999

 CASE REPORTS: FINK
or another ophthalmic condition. She was not taking medi-
cation, topical or systemic, and denied significant use in the
past. There was no family history of cataract or other
ophthalmic disease. Slitlamp examination was entirely nor-
mal, with no evidence of lens opacification.
Preoperative assessment of the right eye showed a mani-
fest refractive error (MRE) of - 9 . 0 0 +2.00 X 40 with an
uncorrected visual acuity (UCVA) of 20/1200 and best
corrected visual acuity (BCVA) of 20/20. White-to-white
measurement (W-W) was 11.5 mm, pupil diameter in good
illumination (PDGI) 3.5 mm, pupil diameter in low illumi-
nation (PDLI) 5.5 mm, anterior chamber depth (ACD)
2.81 mm, axial length (AL) 25.25 mm, lens thickness (LT)
4.35 mm, and keratometry (K1/K2 in diopters) 47.00/45.75.
Intraocular pressure (IOP) was 16 mm Hg. Left eye measure-
ments were MRE - 8 . 7 5 +2.25 × 165, UCVA 20/1200,
BCVA 20/20, W-W 11.5 mm, PDGL 3.5 mm, PDLI
5.5 mm, ACD 2.95 mm, AL 25.00 mm, LT 4.25 mm,
K1/K2 47.00/45.75, and IOP 17 mm Hg.
After full patient counseling, it was decided to proceed
with ICL implantation. One week preoperatively, 2 neody-
mium:YAG laser iridotomies were created at approximately
2 and 10 o'clock positions. Surgery was initially performed in
the right eye. Immediately after induction of general anesthe-
sia, a drop of povidone 50% was instilled into the conjuncti-
val fornices. A 12.0 mm, - 1 0 . 5 0 diopter (D) ICL was
injected through a 2.5 mm clear corneal incision into the
anterior chamber as previously described. ~ Copious sodium
hyaluronate (Healon ®) was used, and care was taken not to
touch the anterior lens capsule during manipulation of the
ICL into the posterior chamber. At the end of surgery, the
Healon was aspirated and acetylcholine chloride (Miochol ®)
injected to constrict the widely dilated pupil. Subconjuncti-
val velosef and depomedrone were injected, and a drop each
/ exact nature were unavailable. The slitlamp examination was
1
Figure 1. (Fink) Case 1 10 months postoperatively shows an
anterior subcapsular cataract.
j CATARACT REFRACT SURG--VOL 25, FEBRUARY 1999
of chlorampheriicol and pilocarpine was instilled. There were
no intraoperative complications.
One week later, uneventful surgery was performed in the
left eye in a similar fashion and a 11.5 mm, - 10.00 D ICL
implanted. The incision was combined with a larger arcuate
keratotomy along the steeper meridian in an attempt to
reduce the astigmatic component. At the same operating
session, an arcuate keratotomy was performed as a secondary
procedure in the right eye. Prednisolone-neomycin drops
3 times daily were prescribed for 1 week postoperatively.
One day after surgery in the left eye, the UCVA in the
right eye was 20/40 + and BCVA was 20/20- with - 1 . 2 5
+ 1.25 X 40. The left eye's UCVA was 20/20- and BCVA,
20/20 w i t h - 0 . 2 5 +0.75 X 180. Postoperative recovery was
uneventful in both eyes with no significant inflammatory,
hypertensive, or hypotensive episodes evident on routine
clinic visits 1 week and 1, 4, and 10 months later. A
satisfactory central vault (gap) was noted between the ante-
rior capsule surface and ICL at each visit. The patient took
no systemic medication.
Four months postoperatively, BCVA was 20/20 in both
eyes. However, there was a suspicion that in the left eye, faint
anterior subcapsular opacification was beginning to form.
The crystalline lens in the right eye was clear. Ten months
postoperatively, when next examined, an anterior subcapsular
cataract involving the superior part of the lens was more
pronounced (Figure 1). The patient remained symptom free,
however. The right eye showed no lens opacification. The
UCVA was 20/30 in the right eye and 20/25 in the left, and
BCVA remained 20/20 in both eyes.
Case 2
A 36-year-old woman with high myopia and astigma-
tism presented for refractive surgery. She had no medical
history of note. Ophthalmic history was negative except for
bilateral ammetropic amblyopia. She was on no medication,
either systemic or topical. Notably, the patient's father had
developed cataract in both eyes in his 50s, but details on the
normal and showed clear crystalline lenses. After full patient
counseling, it was decided to proceed with bilateral ICL
implantation.
Measurements in the right eye were MRE - 1 0 . 0 0
+5.50 X 90, UCVA 20/600, BCVA 20/50, W - W 11.5 mm,
ACD 2.81 mm, AL 22.31 mm, LT 4.91 mm, K1/K2
46.50/43.00, and lOP 18 mm Hg. Left eye measurements
were MRE - 7 . 7 5 + 5.00 × 90, UCVA 20/400, BCVA
20/60, W - W 11.5 mm, ACD 2.95 mm, AL 22.82 mm, LT
4.67 mm, K1/K2 48.00/44.00, and IOP 22 mm Hg.
Neodymium:YAG iridotomies were performed 2 weeks
before surgery. The right eye was operated on first and the
left eye, 6 weeks later. Surgery was performed as in Case 1.
Three-plane clear corneal incisions were used with simulta-
279
 CASE REPORTS: FINK
ne~us arcuate keratotomies along the steep meridians. An
11.5 mm, -9.00 D ICL was implanted in the right eye and
an 11.5 mm -6.50 ICL in the left eye. There were no
intraoperative complications, and prednisolone-neomycin
drops were prescribed for 1 week postoperatively.
Postoperative recovery of both eyes was uneventful and
routine at 1 week and 1, 3, and 6 months. In both eyes, the
vault between the ICL and the anterior lens capsule was
particularly high.
One week after surgery in the left eye, UCVA in the
right eye was 20/40-. Residual MRE was -0.50 +0.50 X
90, although this did not significandy improve BCVA. The
UCVA in the left eye was 20/50. Residual MRE of -0.50
+0.50 × 100 improved BCVA slighdy to 20/50 +.
At a routine 12 month check, the patient reported
reduced acuity in the right eye and seeing halos in reduced
lighting. The left eye maintained good vision and was
asymptomatic. In the right eye, UCVA was 20/60 and BCVA
20/50- with an MRE of -1.50/+2.75 × 110. In the left
eye, UCVA was 20/60 and BCVA 20/50 + with an MRE of
- 1 . 2 5 + 1.25 × 95. An anterior subcapsular cataract was
evident superiorly in the right crystalline lens. The eye was
otherwise quiet. The left crystalline lens was clear. The
vaulting of the ICL remained notably high in both eyes.
When checked 2 months later, an anterior subcapsular
lens opacity had started to appear superotemporally in the
left eye (Figures 2 and 3). Eighteen months postoperatively,
the cataract in the right eye appeared unchanged. In the left
eye, the opacity had progressed and was encroaching on the
optical zone. Then, UCVA was stable in both eyes at 20/50-;
however, the patient reported halos under reduced lighting,
now affecting both eyes.
Figure 2. (Fink) The right eye in Case 2 14 months postopera-
tively shows an early anterior subcapsular cataract.
280 J CATARACTREFRACTSURG--VOL25, FEBRUARY1999
Discussion
Surgical correction of refractive errors involves a
range of procedures. These include corneal modifica-
tion, implantation of supplement~'y lenses, or lens
replacement. More than 1 technique may be applied to
achieve the desired result. Choice of technique depends
on, among other factors, the magnitude and nature of
the refractive error, patient choice, surgeon experience
and preference, and the facilities available.
Short-term follow-up studies have shown ICL im-
plantation to be an effective and safe treatment for
moderate to high myopia and hyperopia, and it com-
pares favorably with PRK and LASIK. ~4 A significant
advantage of ICL implantation over the latter proce-
dures, even for lower refractive errors, is its reversibility.
When compared with clear lens extraction, it has the
advantage of preserving accommodation in prepres-
byopic patients.
Complications reported to date thought to be
directly related to ICL implantation include several
cases of pupillary block glaucoma.l'3'4 All cases were the
result of the closure of or failure to create preoperative
laser iridotomies; therefore, attention to this detail has
prevented further instances. All cases except 2 resolved
after further iridotomies were created. One case was
followed by an episode of malignant glaucoma, which
required a vitrectomy and lens extraction with a satis-
Figure 3. (Fink) The left eye in Case 2 14 months postopera-
tively shows an anterior subcapsular cataract involving the upper
half of the lens.
 CASE REPORTS: FINK
factory visual outcome.* Another case resulted in pro-
gressive glaucoma damage caused by secondary neovas-
cularization of the angle and loss of BCVA.4 Pigment
deposition on the ICL surface has been noted, and a
doubtful case of pigmentary glaucoma that resolved on
ICL removal was reported. 3 Several cases of secondary
glaucoma in steroid responders have been seen2
Other reported complications include transient
corneal edema, subjective edge glare and halos, and
undercorrections, which can be corrected by ICL re-
placement. We have seen exaggerated uveitis after laser
iridotomies that required intensive steroid therapy and
pupil dilation. Rare cases of ICL decentration have
occurred that responded to lens recentration or removal2
Anterior subcapsular cataracts were previously re-
ported as a frequent complication of the posterior
chamber silicone lens, 5'6 and this led to their eventual
withdrawal. The Staar Collamer posterior chamber lens
is made of a proprietary hydrophilic collagen polymer.
A previous report described cataract formation in 3 of
124 implantations. 3 However, 2 were considered to
have been present preoperatively, and 1 was secondary
to the laser iridotomy.
This report details the occurrence of lens opacifica-
tion after ICL implantation in 3 eyes of 2 patients, the
cause of which is uncertain. These 3 cases occurred in a
series of 63 ICL implantations performed over 2 years.
There are several possible causes of the lens opacifi-
cation. Contact between the ICL and lens capsule
leading to altered metabolism beneath the capsule is a
legitimate concern with this posterior chamber lens.
Touch between the posterior pigment epithelium of the
iris and the lens capsule is physiological. This is seen,
for example, in the distribution of pseudoexfoliative
material on the lens surface produced by continual
rubbing of the mobile pupil. 7 However, the surface
qualities of the ICL and its relationship with the lens
capsule are different.
Clinical examination by slitlamp confirms that in
all cases there is a central gap--the lens vault--between
the ICL and the capsule. This extends peripherally to
the sulcus. In Case 2, the vault was especially high.
Anterior segment ultrasound of several eyes confirmed
the presence of a vault, with the ICL resting up against
the pigment epithelium of the iris (Figure 4). Trindade
reported his findings after biomicroscopy of 6 eyes with
the ICL. 8 In some cases, he described touch between
j CATARACTREFRACTSURG--VOL 25, FEBRUARY1999
Figure 4. (Fink) Ultrasound of an eye with the ICL in situ shows
the vault (V) between the ICL (I) and the crystalline lens (C).
the ICL and lens capsule in the midperiphery but no
evidence of opacification in that area at the examina-
tion. In a different study, 1 eye was examined by
ultrasound biomicroscopy during accommodation (when
the anterior lens surface becomes more convex physi-
ologically). The vault shallowed, but there was still no
touch with the lens capsule, even peripherally (A.
Hatsis, MD, Ocular Surgery News, October 1997,
page 45). However, it cannot be assumed that these
relationships are maintained without change in all eyes
during all circumstances such as accommodation, rapid
eye movement, blinking, and change in posture. We
have seen the vault change with variations in pupil size.
Lens fit is clearly relevant to its stability. White-to-
white distance gives an indirect assessment of the
sulcus-to-sulcus diameter. In our experience~ and that
of others2-4 decentration is rare, suggesting that this
approximation is adequate, providing good ICL stabil-
ity. It is also possible that the iris has a beneficial effect
on the centra~ion of the ICL, especially at the mobile
pupil margin over the optic. If the ICL is too small and
does not fit snugly in the sulcus, greater movement
would be expected. Conversely, a too-large lens may
lead to "bunching" in the sulcus and possibly increased
touch peripherally. To date in Case 1, a cataract has
developed only in the eye with the larger ICL.
Stability in the anterior-posterior plane is another
important consideration. Such movement, if present,
may lead to a more percussive type of touch as the ICL
ballots against the lens capsule.
While lens-ICL contact is a possible reason for
cataract formation after ICL implantation, it is as yet
unconfirmed and other possible causes must be consid-
281
 CASE REPORTS:FINK
ered. Accidental touch of the capsule during implanta-
tion may readily lead tb cataract formation and there-
fore must be avoided. If this happens, it is important to
record it in the surgical report for future reference, even
if no immediate damage appears. It is also useful to be
mindful of the complications of other anterior segment
procedures. For example, after trabeculectomy, even
without lenticular touch, cataract formation is consid-
ered to be more likely after anterior chamber shallowing,
air entry in to the anterior chamber, hypertony or
hypotony, hyphema, uveitis, and possibly irregular
circulation of aqueous (normally exclusively through
the pupil) through the fistula, v-12 Such cataracts tend to
be nuclear sclerotic or posterior subcapsular, however.
Laser iridotomies can cause lens opacification. Usu-
ally, they are small and localized, and no progressive
opacities but rather generalized cataract formations
have been reported2 '13a4 This is unlikely to be the cause
in our cases, even though all cataracts started superiorly
near the iridotomies, as they would have been noticed
at the time of surgery against the red reflex. Some
authors believe altered aqueous circulation to be a
potential cause of lens opacity.
Other causes of cataract formation in this age
group include familial tendency, trauma, other ocular
pathology (e.g., inflammation, retinitis pigmentosa),
drugs, radiotherapy, metabolic disorders (e.g., diabetes,
hypocalcaemia), skin disorders (e.g., dermatitis), and
other conditions such as myotonic dystrophy. There
was a familial tendency toward cataract development at
a young age in Case 2, but this was of uncertain
significance. High myopia alone can predispose to
cataract formation, but usually of the posterior subcap-
sular or nuclear sclerotic variety.
Cataract formation after ICL implantation is an
important concern. Nevertheless, it is not a dangerous
complication. It is easily treatable by lens extraction and
IOL implantation. 2a However, loss of accommodation
in a young patient and the additional potential for
complications that further surgery poses make it unde-
sirable. Further long-term follow-up will reveal the
incidence of lens opacification and whether it stays
282 J CATARACT REFRACT SURG~VOL 25, FEBRUARY 1999
within acceptable levels. Additional research of the
mechanisms of cataract formation is required, as are
ways to prevent cataract to make this beneficial proce-
dure as risk free as possible.
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