Presbyopia Clinical Trial
Official title:
Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)
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.
Status | Recruiting |
Enrollment | 480 |
Est. completion date | December 2027 |
Est. primary completion date | December 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key 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. Key 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. |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Centro Oftalmologico Metropolitano | San Juan | |
United States | Chu Eye Institute | Fort Worth | Texas |
United States | Levenson Eye Associates | Jacksonville | Florida |
United States | Eye Surgeons of CNY | Liverpool | New York |
United States | The Eye Institute of Utah | Salt Lake City | Utah |
United States | Wolstan & Goldberg Eye Associates | Torrance | California |
United States | Tulsa Ophthalmology | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit | BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR). | Up to Year 3 | |
Primary | Rate of Adverse Events | 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) |
Up to Year 3 | |
Primary | Rate of Device Deficiencies | 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 |
Up to Year 3 |
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