Purpose To report on 3-year postoperative safety and efficacy outcomes with t he Myopic Implantable Collamer Lens (ICL). Design Prospective nonrandomized clin ical trial. Participants Five hundred twenty-six eyes of 2...Purpose To report on 3-year postoperative safety and efficacy outcomes with t he Myopic Implantable Collamer Lens (ICL). Design Prospective nonrandomized clin ical trial. Participants Five hundred twenty-six eyes of 294 patients with betw een 3.0 and 20.0 diopters (D) of myopia participating in the United States Food and Drug Administration clinical trial of the ICL for myopia. Intervention Impla ntation of the ICL. Main outcome measures Uncorrected visual acuity (VA), refrac tion, best spectacle-corrected VA(BSCVA), adverse events, operative and postope rative complications, lens opacity analysis, subjective satisfaction, and patien t symptoms. Results At 3 years, 59.3%had 20/20 or better VA, and 94.7%had 20/4 0 or better uncorrected VA if BSCVA was 20/20 and patients were targeted for emm etropia; 67.5%of patients were within 0.5 D and 88.2%were within 1.0 D of pred icted refraction. The mean improvement in BSCVA ranged between 0.5 and 0.6 lines . At 3 years postoperatively, 3 eyes (0.8%) decreased by ≥2 lines of BSCVA, in contrast to 40 eyes (10.8%) that improved by a similar amount. Contrast sensit ivity improved postoperatively. Cumulative 3-year corneal endothelial cell loss was under 10%. Early largely asymptomatic, presumably surgically induced anter ior subcapsular opacities (trace or greater) were seen in 14 eyes (2.7%), with only 2 being clinically significant. Five eyes (0.9%) of 3 patients developed n uclear opacities of grade >2 at 2 to 3 years postoperatively. Three (0.6%) ICL removals with cataract extraction and IOL implantation have been performed. Only 0.6%reported dissatisfaction; 97.1%of patients reported they would choose ICL implantation again. Incidences of patient symptoms, glare, halos, double vision , night vision problems, and night driving difficulties decreased or remained un changed after ICL surgery. Conclusion Three-year results from this standardized , multicenter clinical investigation support the safety, efficacy, and predictab ility of ICL surgery to treat moderate to high myopic refractive errors.展开更多
文摘Purpose To report on 3-year postoperative safety and efficacy outcomes with t he Myopic Implantable Collamer Lens (ICL). Design Prospective nonrandomized clin ical trial. Participants Five hundred twenty-six eyes of 294 patients with betw een 3.0 and 20.0 diopters (D) of myopia participating in the United States Food and Drug Administration clinical trial of the ICL for myopia. Intervention Impla ntation of the ICL. Main outcome measures Uncorrected visual acuity (VA), refrac tion, best spectacle-corrected VA(BSCVA), adverse events, operative and postope rative complications, lens opacity analysis, subjective satisfaction, and patien t symptoms. Results At 3 years, 59.3%had 20/20 or better VA, and 94.7%had 20/4 0 or better uncorrected VA if BSCVA was 20/20 and patients were targeted for emm etropia; 67.5%of patients were within 0.5 D and 88.2%were within 1.0 D of pred icted refraction. The mean improvement in BSCVA ranged between 0.5 and 0.6 lines . At 3 years postoperatively, 3 eyes (0.8%) decreased by ≥2 lines of BSCVA, in contrast to 40 eyes (10.8%) that improved by a similar amount. Contrast sensit ivity improved postoperatively. Cumulative 3-year corneal endothelial cell loss was under 10%. Early largely asymptomatic, presumably surgically induced anter ior subcapsular opacities (trace or greater) were seen in 14 eyes (2.7%), with only 2 being clinically significant. Five eyes (0.9%) of 3 patients developed n uclear opacities of grade >2 at 2 to 3 years postoperatively. Three (0.6%) ICL removals with cataract extraction and IOL implantation have been performed. Only 0.6%reported dissatisfaction; 97.1%of patients reported they would choose ICL implantation again. Incidences of patient symptoms, glare, halos, double vision , night vision problems, and night driving difficulties decreased or remained un changed after ICL surgery. Conclusion Three-year results from this standardized , multicenter clinical investigation support the safety, efficacy, and predictab ility of ICL surgery to treat moderate to high myopic refractive errors.
