Implantable contact lens for moderate to high myopia: Phase 1 FDA clinical study with 6 month follow-up

Abstract

Purpose: To assess the short-term safety and efficacy of the implantable contact lens (ICL™) to treat, moderate to high myopia, Setting: Phase 1 U.S. Food and Drug Administration clinical study of the ICL conducted at four sites in the United States. Methods: Ten patients with myopia of 7,00 diopters (D) or greater had implantation of a Staar Surgical ICL and were examined preoperatively (baseline) and 1 day, 1 week, and 1, 3, and 6 months postoperatively. Mean preoperative myopia was 7.75 D (range 7.25 to 9.37 D): Results: Six months postoperatively, 5 of 10 eyes (50%) had an uncorrected visual acuity (UCVA) of 20/20 or better, and all eyes had a UCVA of 20/30 or better. All eyes had a best spectacle-corrected visual acuity (BSCVA), of 20/20 or better and 6 eyes (60%), of 20/15 or better. Six eyes (60%) had an improvement of one or more lines of BSCVA. Mean postoperative spherical equivalent was −0.025 D ± 0.47 (SD). Eight eyes (80%) were within ±0.250 D of emmetropia, and all were within ±1.125 D. No intraoperative or postoperative complications or adverse reactions were observed. Conclusions: The results support the short-term safety, efficacy; and predictability of ICL implantation to treat moderate to high myopia.