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

August 12, 2025 updated by: Alcon Research

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

470

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00921
        • Centro Oftalmologico Metropolitano
  • United States
    • California
      • Torrance, California, United States, 90505
        • Wolstan & Goldberg Eye Associates
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Levenson Eye Associates
    • New York
      • Liverpool, New York, United States, 13088
        • Eye Surgeons of CNY
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Tulsa Ophthalmology
    • Texas
      • Fort Worth, Texas, United States, 76107
        • Chu Eye Institute
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • The Eye Institute of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Models CNWET0, CCWET0
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:
  • Models CNWET2, CNWET3, CNWET4, CNWET5, CNWET6, CCWET-2, CCWET3, CCWET4, CCWET3, CCWET3-T6
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:
  • Model CNWTT0, CCWTT2
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:
  • Models CNWTT2, CNWTT3, CNWTT4, CNWTT5, CNWTT6, CCWTT2, CCWTT3, CCWTT4, CCWTT5, and CCWTT6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to Year 3
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)
Up to Year 3
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
Up to Year 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Trial Lead, Surgical, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILE632-I001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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