Study of 900 ICLs reveals good safety and long-term refractive results, says Spanish specialist

Ana Hidalgo-Simón MD, PhD
in Barcelona

Javier Puig MD

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.

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 year.

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. Best corrected visual acuity improved an average of 1.27 Snellen lines in the general group and 2.03 lines in the bioptics group.
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 (0.11%).

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 endothelium (0.99%).

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 1%.

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, he noted.

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%.

Javier Puig MD
Barcelona Institute of Ophthalmology, Spain
Email: 29213jpg@comb.es

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