Post Market Clinical Evaluation of Clareon PanOptix Pro and Clareon PanOptix Pro Toric IOLs

Alcon

Status: Enrolling

Conditions: Presbyopia; Aphakia

Treatments: Device: Clareon PanOptix Pro/Pro Toric Trifocal IOL; Procedure: Phacoemulsification

Study type: Interventional

Funder types: Industry

Identifiers

NCT07161635

ILQ137-P001

Details and patient eligibility

About

The purpose of this study is to collect safety and performance data on two approved intraocular lenses (IOLs). This study will be conducted in participants who require cataract surgery in both eyes. The IOLs are designed to provide vision at far, arm's length, and near.

Full description

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. Both eyes will undergo cataract surgery. The second eye surgery will occur within 7 to 14 days of the first.

Enrollment: 120 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subjects with cataracts in both eyes, planned for removal by routine surgery (phacoemulsification);
• Subject must be able to understand and sign an approved informed consent form;
• Subject is willing to complete all the required study visits for the duration of the study;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Ocular conditions as specified in the protocol;
• Subjects who desire monovision correction;
• Previous intraocular or corneal surgery;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Clareon PanOptix Pro/Pro Toric Trifocal IOL

Experimental group

Description:

The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro and/or PanOptix Pro Toric IOLs will be implanted.

Treatment:

Procedure: Phacoemulsification

Device: Clareon PanOptix Pro/Pro Toric Trifocal IOL