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

Not Applicable

Not yet recruiting

• Conditions: Aphakia; Presbyopia

• Registration Number: NCT07161635
• Lead Sponsor: Alcon Research

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.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

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