ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-19
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05796453

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form.
  2. * 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.
  3. * Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
  4. * Other protocol-defined inclusion criteria may apply.
  1. * Subject is currently participating in another investigational drug or device study.
  2. * Subject has had corneal refractive surgery after Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOL implantation.
  3. * Subject is pregnant at the time of enrollment.
  4. * Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Principal Investigator

Clinical Trial Lead, Surgical
STUDY_DIRECTOR
Alcon Research, LLC

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Alcon Research

  • Clinical Trial Lead, Surgical, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-09-19
Study Completion Date2028-06

Study Record Updates

Study Start Date2023-09-19
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • Cataract surgery

Additional Relevant MeSH Terms

  • Aphakia
  • Astigmatism
  • Presbyopia