NCT05799950

A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 138 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

The purpose of this post-market clinical follow-up (PMCF) study is to describe the long-term safety and performance of AcrySof Single-Piece and AcrySof Multi-Piece monofocal intraocular lenses (IOLs).

Detailed description

The study includes a retrospective chart review for pre-operative, operative, and post-operative data collection, and a prospective, standard-of-care visit to collect study endpoints.

Conditions

• Aphakia

Interventions

Type	Name	Description
DEVICE	AcrySof single-piece IOL	Acrylic single-piece intraocular lens placed in the capsular bag in the posterior chamber of the eye during cataract surgery as a replacement for the natural crystalline lens.
DEVICE	AcrySof multi-piece IOL	Acrylic multi-piece intraocular lens placed in the capsular bag in the posterior chamber of the eye during cataract surgery as a replacement for the natural crystalline lens.

Timeline

• Start date: 2023-08-28
• Primary completion: 2025-06-02
• Completion: 2025-06-02
• First posted: 2023-04-05
• Last updated: 2025-08-14

Locations

7 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated device study