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

NCT07161635 | Active Not Recruiting FDA Device

• 1 other identifier: ILQ137-P001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Aphakia; Presbyopia

Keywords

Cataract; Eye Surgery

Outcome Measures

Primary Outcomes (1)

• Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA)

  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.

  Month 1 and Month 6 postoperative

Study Arms (1)

Clareon PanOptix Pro/Pro Toric Trifocal IOL

EXPERIMENTAL

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

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

Interventions

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.

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

Clareon PanOptix Pro/Pro Toric Trifocal IOL

Phacoemulsification PROCEDURE

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

Clareon PanOptix Pro/Pro Toric Trifocal IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Ocular conditions as specified in the protocol;
• Subjects who desire monovision correction;
• Previous intraocular or corneal surgery;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (5)

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Carolina Eyecare Physicians LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

Houston Eye Associates

Houston, Texas, 77008, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

Related Links

• Educational

MeSH Terms

Conditions

Aphakia; Presbyopia; Cataract

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Sr. Principal Clinical Trial Operations, Surgical

  Alcon Research LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 8, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)