Clareon IOL Retrospective Data Collection
NCT05796674 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1090
Last updated 2023-10-18
Summary
The purpose of this study is to provide real world evidence (RWE) on the performance of the Clareon ultraviolet absorbing (UVA) intraocular lenses (IOLs) to support the overall body of evidence on the Clareon IOL family.
Conditions
- Aphakia
- Astigmatism
Interventions
- DEVICE
-
Clareon UVA IOL
Clareon UVA IOL placed in the capsular bag in the posterior chamber of the eye during cataract surgery to replace the natural crystalline lens. Models CC60WF and CCA0T0 are indicated for the visual correction of aphakia. Models CCW0T3, CCW0T4, CCW0T5, and CCW0T6 are indicated for the visual correction of aphakia and preexisting corneal astigmatism.
- DEVICE
-
WaveTec Optiwave Refractive Analysis (ORA) System
Intra-operative system used during refractive cataract surgery to capture wavefront images of the patient's eye for the purpose of optimizing IOL implantation
- PROCEDURE
-
Cataract surgery
Cataract extraction by phacoemulsification, followed by implantation with a Clareon UVA IOL
Sponsors & Collaborators
-
Alcon Research
lead INDUSTRY
Principal Investigators
-
Clinical Lead, Surgical · Alcon Research, LLC
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-18
- Primary Completion
- 2023-09-12
- Completion
- 2023-09-12
- FDA Device
- Yes
Countries
- United States
Study Locations
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