Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Clareon Vivity IOL - Non Toric Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon Vivity IOL. |
Device: Clareon Vivity IOL - Non Toric
Spherical extended vision IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed.
Other Names:
|
| Experimental: Clareon Vivity IOL - Toric Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon Vivity IOL. |
Device: Clareon Vivity IOL - Toric
Toric extended vision IOL implanted in the capsular bag of the eye for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients in whom a cataractous lens has been removed.
Other Names:
|
| Experimental: Clareon PanOptix IOL - Non Toric Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon PanOptix IOL. |
Device: Clareon PanOptix Trifocal IOL - Non Toric
Spherical trifocal IOL implanted in the capsular bag of the eye for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed.
Other Names:
|
| Experimental: Clareon PanOptix IOL - Toric Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon PanOptix IOL. |
Device: Clareon PanOptix Trifocal IOL - Toric
Toric trifocal IOL implanted in the capsular bag of the eye for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients in whom a cataractous lens has been removed.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit [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).
- Rate of Adverse Events [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)
- Rate of Device Deficiencies [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
Eligibility Criteria
Criteria
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.
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Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Trial Lead, Surgical, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ILE632-I001