Post Market Clinical Follow-up (PMCF) Study of Clareon Vivity & Clareon PanOptix
Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)
1 other identifier
interventional
470
2 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
September 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
August 14, 2025
August 1, 2025
4.7 years
March 22, 2023
August 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (4)
Clareon Vivity IOL - Non Toric
EXPERIMENTALImplantation 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 Vivity IOL - Toric
EXPERIMENTALImplantation 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
EXPERIMENTALImplantation 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 PanOptix IOL - Toric
EXPERIMENTALImplantation 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (7)
Wolstan & Goldberg Eye Associates
Torrance, California, 90505, United States
Levenson Eye Associates
Jacksonville, Florida, 32204, United States
Eye Surgeons of CNY
Liverpool, New York, 13088, United States
Tulsa Ophthalmology
Tulsa, Oklahoma, 74104, United States
Chu Eye Institute
Fort Worth, Texas, 76107, United States
The Eye Institute of Utah
Salt Lake City, Utah, 84107, United States
Centro Oftalmologico Metropolitano
San Juan, 00921, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Lead, Surgical
Alcon Research, LLC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2023
First Posted
April 3, 2023
Study Start
September 19, 2023
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
August 14, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share