U.S. Food and Drug Administration clinical trial of the Implantable Contact Lens for moderate to high myopia.

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