Purpose: To assess a single-piece monofocal hydrophobic acrylic intraocular lens (IOL) with hydroxyethyl methacrylate (HEMA) (Clareon) contained in automated preloaded delivery system (AutonoMe).
Setting: 18 surgical sites in Japan.
Design: Observational study.
Methods: 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.
Results: 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.
Conclusions: 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.
Trial registration: ClinicalTrials.gov NCT03824028.
Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of ASCRS and ESCRS.