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

Sponsored by Alcon Research

About this trial

Last updated 2 years ago

Study ID

ILE632-I001

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the Participation Requirements?

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.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting