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

Alcon

Status: Enrolling

Conditions: Astigmatism; Presbyopia; Aphakia

Treatments: Device: Clareon PanOptix Trifocal IOL - Toric; Device: Clareon PanOptix Trifocal IOL - Non Toric; Device: Clareon Vivity IOL - Toric; Device: Clareon Vivity IOL - Non Toric

Study type: Interventional

Funder types: Industry

Identifiers

NCT05796453

ILE632-I001

Details and patient eligibility

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.

Full description

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 4 patient groups

Clareon Vivity IOL - Non Toric

Experimental group

Description:

Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon Vivity IOL.

Treatment:

Device: Clareon Vivity IOL - Non Toric

Clareon Vivity IOL - Toric

Experimental group

Description:

Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon Vivity IOL.

Treatment:

Device: Clareon Vivity IOL - Toric

Clareon PanOptix IOL - Non Toric

Experimental group

Description:

Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon PanOptix IOL.

Treatment:

Device: Clareon PanOptix Trifocal IOL - Non Toric

Clareon PanOptix IOL - Toric

Experimental group

Description:

Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon PanOptix IOL.

Treatment:

Device: Clareon PanOptix Trifocal IOL - Toric