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

Last updated: March 11, 2025
Sponsor: Alcon Research
Overall Status: Active - Recruiting

Phase

N/A

Condition

Presbyopia

Astigmatism

Treatment

Clareon Vivity IOL - Toric

Clareon PanOptix Trifocal IOL - Non Toric

Clareon Vivity IOL - Non Toric

Clinical Study ID

NCT05796453
ILE632-I001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Subject or legally authorized representative must be able to understand and sign anapproved Informed Consent Form.

  • Subject must have had bilateral implantation of Clareon Vivity, Clareon VivityToric, Clareon PanOptix, or Clareon PanOptix Toric IOLs between 3-6 months prior toenrollment.

  • Subject must have a documented medical history and required pre-operative baselineinformation available for retrospective data collection.

  • Other protocol-defined inclusion criteria may apply.

Exclusion

Key Exclusion Criteria:

  • Subject is currently participating in another investigational drug or device study.

  • Subject has had corneal refractive surgery after Clareon Vivity, Clareon VivityToric, 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

Total Participants: 480
Treatment Group(s): 4
Primary Treatment: Clareon Vivity IOL - Toric
Phase:
Study Start date:
September 19, 2023
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • Centro Oftalmologico Metropolitano

    San Juan, 00921
    Puerto Rico

    Active - Recruiting

  • Wolstan & Goldberg Eye Associates

    Torrance, California 90505
    United States

    Active - Recruiting

  • Levenson Eye Associates

    Jacksonville, Florida 32204
    United States

    Active - Recruiting

  • Eye Surgeons of CNY

    Liverpool, New York 13088
    United States

    Active - Recruiting

  • Tulsa Ophthalmology

    Tulsa, Oklahoma 74104
    United States

    Active - Recruiting

  • Chu Eye Institute

    Fort Worth, Texas 76107
    United States

    Active - Recruiting

  • Contact Alcon Call Center for Trial Locations

    Fort Worth, Texas 76134
    United States

    Site Not Available

  • The Eye Institute of Utah

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

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