Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05796453

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Aphakia Astigmatism Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Oftalmologico Metropolitano, San Juan, Puerto Rico

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clareon Vivity IOL - Non Toric

Device

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

Clareon Vivity IOL - Toric

Device

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

Clareon PanOptix Trifocal IOL - Non Toric

Device

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

Clareon PanOptix Trifocal IOL - Toric

Device

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

Primary outcomes

  1. 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).

  2. 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)

  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

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 3, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.