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

Description

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.

Conditions

Aphakia, Astigmatism, Presbyopia

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Aphakia
Intervention / Treatment

-

Contacts and Locations

Torrance

Wolstan & Goldberg Eye Associates, Torrance, California, United States, 90505

Jacksonville

Levenson Eye Associates, Jacksonville, Florida, United States, 32204

Liverpool

Eye Surgeons of CNY, Liverpool, New York, United States, 13088

Tulsa

Tulsa Ophthalmology, Tulsa, Oklahoma, United States, 74104

Fort Worth

Chu Eye Institute, Fort Worth, Texas, United States, 76107

Salt Lake City

The Eye Institute of Utah, Salt Lake City, Utah, United States, 84107

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alcon Research,

Clinical Trial Lead, Surgical, STUDY_DIRECTOR, Alcon Research, LLC

Study Record Dates

2027-12