Clareon PanOptix Pro vs. Clareon PanOptix - Study A

Alcon

Status: Active, not recruiting

Conditions: Presbyopia; Aphakia

Treatments: Procedure: Cataract surgery; Device: CPO IOL; Device: CPO Pro IOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT06400745

ILQ137-C002-A

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.

Full description

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.

Enrollment: 79 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Understand and sign an ethics committee-approved informed consent form;
• Willing and able to attend all scheduled study visits as required by the protocol;
• Planned cataract surgery (both eyes);
• Preoperative corneal astigmatism less that 1.00 diopter in each eye.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;
• Ocular conditions as specified in the protocol;
• Subjects who desire monovision correction.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 2 patient groups

CPO Pro IOL

Experimental group

Description:

CPO Pro IOL implanted in the first eye, as randomized. The fellow eye will receive CPO IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.

Treatment:

Device: CPO Pro IOL

Device: CPO IOL

Procedure: Cataract surgery

CPO IOL

Active Comparator group

Description:

CPO IOL implanted in the first eye, as randomized. The fellow eye will receive CPO Pro IOL. The second eye surgery will occur approximately 7-14 days after the first eye surgery.

Treatment:

Device: CPO Pro IOL

Device: CPO IOL

Procedure: Cataract surgery