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

NCT07161635 — Not applicable, Completed, 110 participants, Alcon Research

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Registry	NCT07161635
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	110 (Actual)
Sponsor	Alcon Research (Industry)
Conditions	Aphakia, Presbyopia
Interventions	Clareon PanOptix Pro/Pro Toric Trifocal IOL, Phacoemulsification (Device, procedure)
Dates	start 2025-10-14, primary completion 2026-10-07, completion 2026-10-07, first posted 2025-09-08, last updated 2026-10-19
Locations	5 sites in United States

-Summary

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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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Clareon PanOptix Pro/Pro Toric Trifocal IOL	Experimental	Device: Clareon PanOptix Pro/Pro Toric Trifocal IOL; Procedure: Phacoemulsification	The clouded lens will be removed by phacoemulsification, after which the PanOptix Pro and/or PanOptix Pro Toric IOLs will be implanted.

Clareon PanOptix Pro/Pro Toric Trifocal IOL (Device), also known as 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: 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.
Phacoemulsification (Procedure): Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for IOL implantation.

+Outcome measures

Primary outcomes

Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) [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.

+Eligibility

Sex: All, ages: 22 Years to any

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.

+Locations (5)

Facility	City	Country
Wolstan & Goldberg Eye Associates	Torrance, California	United States
Moyes Eye Center	Kansas City, Missouri	United States
Carolina Eyecare Physicians LLC	Mt. Pleasant, South Carolina	United States
Houston Eye Associates	Houston, Texas	United States
The Eye Institute of Utah	Salt Lake City, Utah	United States

+Investigators

Sr. Principal Clinical Trial Operations, Surgical, Study director, Alcon Research LLC