Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix

Not Applicable

Recruiting

• Conditions: Aphakia; Presbyopia; Astigmatism
• Interventions: Device: Clareon Vivity IOL - Toric; Device: Clareon PanOptix Trifocal IOL - Non Toric; Device: Clareon Vivity IOL - Non Toric; Device: Clareon PanOptix Trifocal IOL - Toric

• Registration Number: NCT05796453
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-03
• Study Start: 2023-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clareon Vivity IOL - Toric	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.
Clareon PanOptix IOL - Non Toric	Clareon PanOptix Trifocal 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.
Clareon Vivity IOL - Non Toric	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.
Clareon PanOptix IOL - Toric	Clareon PanOptix Trifocal 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.

Primary Outcome Measures

Name	Time	Method
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 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
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)

Trial Locations

Locations (7)

Wolstan & Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

Levenson Eye Associates; 🇺🇸 Jacksonville, Florida, United States

Eye Surgeons of CNY; 🇺🇸 Liverpool, New York, United States

Tulsa Ophthalmology; 🇺🇸 Tulsa, Oklahoma, United States

The Eye Institute of Utah; 🇺🇸 Salt Lake City, Utah, United States

Centro Oftalmologico Metropolitano; 🇵🇷 San Juan, Puerto Rico

Chu Eye Institute; 🇺🇸 Fort Worth, Texas, United States