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

In by Hannah Schaffner

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

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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.

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.
clinicaltrials.gov

Eligibility

Inclusion 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.
Exclusion Criteria
  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.
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