A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
NCT05799950 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 138
Last updated 2025-08-14
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).
Conditions
- Aphakia
Interventions
- 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.
Sponsors & Collaborators
-
Alcon Research
lead INDUSTRY
Principal Investigators
-
Clinical Lead, Surgical · Alcon Research, LLC
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-28
- Primary Completion
- 2025-06-02
- Completion
- 2025-06-02
- FDA Device
- Yes
Countries
- United States
- Puerto Rico
Study Locations
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