Study of 900 ICLs reveals good safety and long-term
refractive results, says Spanish specialist
Ana Hidalgo-Simón MD, PhD
Implantable contact lenses (ICLs, Staar) are safe and afford good
long-term refractive results, according to a study of 900 cases
carried out by Spanish ophthalmologist Javier Puig MD.
visual acuity improved an average of 1.27 Snellen lines in the general
group and 2.03 lines in the bioptics group.
A total of 901 eyes of 547 patients were included in the retrospective
study. The myopic power of the lens implanted ranged from -3.0 D
to -22.5 D. The spherical equivalent (SE) range operated on was
– 8.0 D to –29.9 D.
The implants were performed between February 1997 and June 2001
and follow-up periods ranged from six to 54 months. Of the 900 eyes,
282 were bioptics. The mean SE of the whole series improved from
-16.98 D preoperatively to -1.19 D one week after implanting the
ICL. That level was maintained at three months, six months and one
Mean uncorrected visual acuity improved from 0.02 preoperatively
to 0.62 after implantation (0.025 for bioptics). After the application
of Lasik surgery three months after implantation, visual acuity
improved in the bioptic group to 0.69. The improvement persisted
at six and 12 months.
The most frequent intraoperative complication recorded was corneal
oedema, observed in 2.99% of cases. Other complications were relatively
rare and included iridectomy bleeding (0.99%); Descement’s
membrane detachment (0.44%); discoria (0.33%); and inverted ICL
Early postoperative complications included incisional oedema in
13.87% of cases. Superficial punctate keratitis (SPK) and insufficient
vaulting were seen in 8.87% and 4.66% of implants. Not all cases
of insufficient vaulting resulted in cataracts, but some vaulting
was observed in most cataract cases.
“The main reason for this to happen is that there is a slight
margin for error in the calculation of the final position of the
lens in the sulcus,” he explained.
Less common complications at this stage included pupillary block
(1.99%), corneal oedema (1.88%) and the presence of pigment in the
The main late postoperative complication was the presence of halos
and glare (38%). Pigment deposition on the lens (35%) and rises
in IOP (30%) were also relatively frequent. Other late complications
such as deposits of pigment on the endothelium and decentration
were observed in between 2% and 4% of the implants. Monocular diplopia,
retinal detachment and macular haemorrhage were seen in less than
Cataracts developed in a small proportion of patients (2.5%). They
appeared between a few months and up to a year postoperatively.
Most of theses case were V2 type lenses.
Newer models implanted more recently (V3 and V4) have a clearly
reduced incidence of cataracts, but Dr Puig acknowledged that these
cases also have a shorter follow-up period of observation.Four lenses
required explantation, all due to different causes: excessive glare
and halos at night; a haptic fold that resulted in irritative inflammation;
an excessive vault which resulted in unresponsive midriasis; and
surprise refractive results that could not be corrected with Lasik.
The explantation process is extremely simple with these lenses,
Dr Puig considered the predictability of the lenses good, with 76%
of patients ending up within 1.0 D of target refraction. Stability
one year after surgery was 97%.
Barcelona Institute of Ophthalmology, Spain