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

Launched by ALCON RESEARCH · Mar 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety and performance of specific types of intraocular lenses (IOLs) called Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, and Clareon PanOptix Toric. These lenses are used to help people see better after cataract surgery, especially for conditions like aphakia (missing the natural lens), astigmatism (blurred vision), and presbyopia (difficulty seeing close objects due to aging). The trial is currently looking for participants who have had one of these lenses implanted in both eyes at least 3 to 6 months prior to joining the study.

To be eligible for the trial, participants must be between 65 and 74 years old and able to understand and sign a consent form. They should also have a medical history and pre-operative information available for the researchers to review. Those who are pregnant, currently involved in another clinical study, or have had certain eye surgeries after their lens implantation are not eligible. Participants can expect to share their experiences and health information, which will help researchers understand how well these lenses work over time and ensure they are safe for future patients.

Gender

ALL

Eligibility criteria

• 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.