Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Aphakia
- Sponsor
- Alcon Research
- Enrollment
- 470
- Locations
- 7
- Primary Endpoint
- Rate of Device Deficiencies
- Status
- Active, Not Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.
Detailed Description
Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected from time of study enrollment through the Year 3 follow-up visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form.
- •Subject must have had bilateral implantation of Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOLs between 3-6 months prior to enrollment.
- •Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Subject is currently participating in another investigational drug or device study.
- •Subject has had corneal refractive surgery after Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOL implantation.
- •Subject is pregnant at the time of enrollment.
- •Other protocol-defined exclusion criteria may apply.
Outcomes
Primary Outcomes
Rate of Device Deficiencies
Time Frame: Up to Year 3
Device deficiencies will be assessed at each prospective visit. Examples include the following: * Failure to meet product specifications (e.g., incorrect IOL power) * IOL defect * Broken IOL optic * Broken IOL haptic * Scratched IOL optic * Unsealed device packaging * Suspected product contamination * Lack of performance
Rate of Adverse Events
Time Frame: Up to Year 3
Protocol-specified ocular adverse events will be assessed at each prospective visit and include the following: * Cystoid Macular Edema (CME) * Hypopyon * Endophthalmitis * Lens dislocation * Pupillary Block * Retinal Detachment * Secondary Surgical Interventions (Explantation/exchange/repositioning)
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit
Time Frame: Up to Year 3
BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).