NCT06060041

IC-8 Apthera IOL New Enrollment Post Approval Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 435 (estimated)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: —

Summary

The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.

Detailed description

Prospective, multi-center, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Conditions

• Cataract
• Presbyopia
• Posterior Capsule Opacification

Timeline

• Start date: 2023-09-08
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2023-09-29
• Last updated: 2026-01-12

Locations

14 sites across 1 country: United States