U.S. Food and Drug Administration clinical trial of the Implantable Contact Lens for moderate to high myopia☆
Received 25 October 2001; accepted 2 August 2002.
Abstract
Purpose
To assess the safety and efficacy of the Implantable Contact Lens (ICL) to treat moderate to high myopia.
Design
Prospective nonrandomized clinical trial.
Participants
Five hundred twenty-three eyes of 291 patients with between 3 and 20.0 diopters (D) of myopia participating in the U. S. Food and Drug Administration clinical trial of the ICL for myopia.
Intervention
Implantation of the ICL.
Main outcome measures
Uncorrected visual acuity (UCVA), refraction, best spectacle-corrected visual acuity (BSCVA), adverse events, operative and postoperative complications, lens opacity analysis (Lens Opacity Classification System III), subjective satisfaction, and symptoms.
Results
Twelve months postoperatively, 60.1% of patients had a visual acuity of 20/20 or better, and 92.5% had an uncorrected visual acuity of 20/40 or better. Patients averaged a 10.31-line improvement in UCVA, 61.6% of patients were within 0.5 D, and 84.7% were within 1.0 D of predicted refraction. Only one case (0.2%) lost > 2 lines of BSCVA. Gains of 2 or more lines of BSCVA occurred in 55 cases (11.8%) at 6 months and 41 cases (9.6%) at 1 year after ICL surgery. Early and largely asymptomatic, presumably surgically induced anterior subcapsular (AS) opacities were seen in 11 cases (2.1%); an additional early AS opacity (0.2%) was seen because of inadvertent anterior chamber irrigation of preservative-containing solution at surgery. Two (0.4%) late (≥ 1 year postoperatively) AS opacities were observed. Two (0.4%) ICL removals with cataract extraction and intraocular lens implantation have been performed. Patient satisfaction (very/extremely satisfied) was reported by 92.4% of subjects on the subjective questionnaire; only four patients (1.0%) reported dissatisfaction. Slightly more patients reported an improvement at 1 year over baseline values for the following subjective symptoms: quality of vision, glare, double vision, and night driving difficulties. Only a 3% difference between pre-ICL and post-ICL surgery was reported for haloes.
Conclusions
The results support the safety, efficacy, and predictability of ICL implantation to treat moderate to high myopia.
Reprints requests to Darcy Smith, STAAR Surgical Company, 1911 Walker Avenue, Monrovia, CA 91016, USA.
ABSTRACT