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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Aphakia Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wolstan & Goldberg Eye Associates, Torrance, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clareon PanOptix Pro/Pro Toric Trifocal IOL

Device

Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.

Other names: Clareon PanOptix Pro Trifocal IOL Models PXYWT0, PXCWT0, PXYAT0, PXCAT0, Clareon PanOptix Pro Trifocal Toric IOL Models PXYWT3- PXYWT6, PXCWT3-T6, PXYAT3-PXYAT6, PXCAT3-PXCAT6

phacoemulsification

Procedure

Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for IOL implantation.

Primary outcomes

Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)

Time frame: Month 1 and Month 6 postoperative

Visual Acuity (VA) will be assessed for both eyes together (binocular) using Early Treatment Diabetic Retinopathy Study (ETDRS) reading charts at a distance of 4 meters from the subject under photopic (well-lit) conditions with correction in place. BCDVA will be measured in logarithm Minimum Angle of Resolution (logMAR). LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision), with lower scores indicating better vision.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 8, 2025
Registry last updated: Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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