One-year multicenter evaluation of a new hydrophobic acrylic intraocular lens with hydroxyethyl methacrylate in an automated preloaded delivery system.

Abstract

To assess a single-piece monofocal hydrophobic acrylic intraocular lens (IOL) with hydroxyethyl methacrylate (HEMA) (Clareon) contained in automated preloaded delivery system (AutonoMe). 18 surgical sites in Japan. Observational study. In patients undergoing phacoemulsification and IOL implantation of a new hydrophobic acrylic IOL using an automated injector, clinical data were collected preoperatively and at 1 day, 1 week, and 1 month, 6 months, and 12 months postoperatively. The degree of glistenings was graded on a 4-point scale. The surgeons rated usability and performance of the IOL delivery system on a 5-point scale. The study enrolled 384 eyes of 384 patients, ranging in age from 41 to 93 (73.8 ± 8.2, mean ± SD) years. The percentage of eyes with corrected distance visual acuity of 20/25 or better at 1 day, 1 week, and 1 month, 6 months, and 12 months postoperatively was 82.6%, 91.9%, 92.8%, 96.6%, and 95.2%, respectively. Refractive error was within 1.0 diopter in approximately 90% of cases. No glistenings were found in all cases throughout the study period. The rate of Nd:YAG laser posterior capsulotomy was 0.9% at 1 year. The IOL delivery system received high ratings on its usability and performance by the surgeons. The new hydrophobic acrylic IOL with HEMA showed excellent visual and refractive outcomes without developing glistenings throughout the 1-year study period. The surgeons gave high marks for usability and performance of the automated preloaded delivery system.