Clareon PanOptix Pro vs. Clareon PanOptix - Study B

NCT06401551 | Completed Results FDA Device

• 1 other identifier: ILQ137-C002-B
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Aphakia; Presbyopia

Keywords

Cataract; IOL

Outcome Measures

Primary Outcomes (1)

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

  Visual Acuity (VA) was assessed for each eye individually 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 was 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 2 postoperative

Study Arms (2)

CPO Pro IOL

EXPERIMENTAL

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.

Device: CPO Pro IOL; Device: CPO IOL; Procedure: Cataract Surgery

CPO IOL

EXPERIMENTAL

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.

Device: CPO Pro IOL; Device: CPO IOL; Procedure: Cataract Surgery

Interventions

CPO Pro IOL DEVICE

Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining comparable distance visual acuity. The Clareon™ PanOptix™ Pro Trifocal IOL is designed to enhance distance image quality by reducing chromatic aberration.

Also known as: Clareon PanOptix Pro Trifocal IOL, Model PAYWT0

CPO IOL; CPO Pro IOL

CPO IOL DEVICE

Intraocular lens (IOL) implanted in the eye for the visual correction of aphakia in adult patients with less than 1 diopter of preexisting corneal astigmatism in whom a cataractous lens has been removed. The IOL is intended to mitigate the effects of presbyopia on intermediate and near visual acuity while maintaining distance visual acuity.

Also known as: Clareon PanOptix, Model CNWTT0

CPO IOL; CPO Pro IOL

Cataract Surgery PROCEDURE

Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL

CPO IOL; CPO Pro IOL

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (8)

Wolstan & Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Grosinger, Spigelman & Grey Eye Surgeons, P.C.

Bloomfield Hills, Michigan, 48302, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Carolina Eye Care Physicians

Charleston, South Carolina, 29414, United States

Location

Vision for Life

Nashville, Tennessee, 37205, 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

MeSH Terms

Conditions

Aphakia; Presbyopia; Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Director Clinical Trial Management, Surgical IOL
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Principal Clinical Trial Lead

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Contralateral (split face) study design

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 6, 2024
• Study Start: June 18, 2024
• Primary Completion: December 13, 2024
• Study Completion: April 30, 2025
• Last Updated: February 11, 2026
• Results First Posted: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)