NCT07099079

Post-Market Clinical Follow-Up Study on the Rotational Stability of an Intraocular Lens After Cataract Surgery

Post-Market Clinical Follow-up Trial to Investigate the Rotational Stability of the Hydrophobic Intraocular Lens RAO800S

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 92 (estimated)
• Sponsor: Rayner Intraocular Lenses Limited · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: —

Summary

The goal of this post-market, prospective study at multiple clinics is to evaluate the rotational stability of the RayOne Model RAO800S non-toric monofocal intraocular lens with orientation marks in adult patients undergoing cataract surgery in both eyes. The main question it aims to answer is how stable the RayOne RAO800S lens is approximately 5 months (120 to 150 days) after surgery day. Participants are adults already scheduled to undergo cataract surgery as part of clinical routine. They will be asked to attend regular follow-up visits at the clinic, where eye images will be taken to assess the rotational stability of the implanted lens.

Detailed description

This post-market clinical follow-up (PMCF) study is a prospective, multicenter investigation in European sites. It evaluates the rotational stability of the RayOne Model RAO800S, a non-toric monofocal intraocular lens with orientation marks, following bilateral implantation. Participants will be assessed approximately 5 months (120 to 150 days) post-operatively.

Conditions

• IOL, Cataract

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-10-31
• Completion: 2026-11-30
• First posted: 2025-08-01
• Last updated: 2025-08-01