Post-Market Safety Study of the IC-8 Apthera Intraocular Lens After Treatment for Posterior Capsule Opacification

What this Trial Is About

Researchers are evaluating the safety of the IC-8 Apthera intraocular lens IOL after treatment for posterior capsular opacification PCO, a common complication following IC-8 Apthera IOL implantation. This prospective, multi-center, non-randomized study focuses on patients who have already received the IC-8 Apthera IOL and now require NdYAG laser capsulotomy for PCO. The study aims to verify post-market safety following training in a standardized laser treatment technique. Participants previously implanted with the IC-8 Apthera IOL and experiencing PCO will be treated with NdYAG laser capsulotomy using a sponsor-recommended method. There is one study group, and subjects will be followed for 24 months after their IC-8 Apthera IOL implantation. The study includes about six visits over this two-year period to monitor safety and treatment outcomes. During the study, participants will undergo assessments of laser treatment outcomes, any complications, and IOL-related evaluations. Researchers will track additional laser treatments, secondary surgical interventions, ocular and serious adverse events, and subjective visual disturbances using specific questionnaires. The study lasts for two years post-implantation, with regular visits to ensure thorough monitoring of participant eye health and treatment effects.

IC-8 Apthera IOL New Enrollment Post Approval Study