EFFICACY AND SAFETY WITH ICL IMPLANTATION: 10 YEARS OF EXPERIENCE

To assess the long-term clinical outcomes of implantation of a posterior chamber phakic intra-ocular lens (Visian implantable Collamer lens [ICL]; STAAR Surgical, Nidau, Switzerland) for correction of myopia and hyperopia after 10 years of experience in our center.

Department of Ophthalmology, Hospital da Luz Lisboa, Portugal

We retrospectively evaluated 412 eyes of 222 consecutive patients who underwent ICL implantation and routine postoperative examinations in one center. 110 lens were ICL model V4, 53 model V4b, 192 model V4c and 57 model V5. 11 eyes had hyperopic refractive errors.  Mean preoperative spherical equivalent was -6,10 D (range -20,50 to +7,13 D). Mean follow-up was 27,5 months. Before and 1 and 6 months and 1 to 5 years after surgery we assessed the safety, efficacy, predictability, stability and adverse events of the surgery. Endothelial cell count was evaluated with specular microscopy before and up to 7 years after surgery.

Mean postoperative spherical equivalent refraction at 1 month was -0.22 D, with 96% eyes within +/-1.00 D and 88% eyes within +/-0.50 D of emmetropia. The mean safety index was 1,03. Mean (SD) manifest refraction changes of -0.38 D occurred from 1 month to 5 years after surgery. Endothelial cell count showed a reduction of 5,6% in central endothelial cell density over a 7 years period. 12 eyes (2,91%) developed cataract during the 10 years follow-up. Of these 6 eyes (1,50%) underwent cataract surgery. No vision-threatening complications occurred during the observation period.

Implantation of ICLs is safe and effective and provides predictable and stable refractive results in the treatment of myopia during a 10-year observation period, suggesting its viability as a surgical option for the treatment of such eyes. Our conclusions regarding its use for the correction of hyperopia are limited by the reduced number of cases included.