Clareon PanOptix Pro vs. Clareon PanOptix - Study A

December 3, 2025 updated by: Alcon Research

Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 6 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90505
        • Wolstan & Goldberg Eye Associates
    • Michigan
      • Bloomfield Hills, Michigan, United States, 48302
        • Grosinger, Spigelman & Grey Eye Surgeons, P.C.
    • Missouri
      • Kansas City, Missouri, United States, 64154
        • Moyes Eye Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Carolina Eyecare Physicians, LLC
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Vision for Life
    • Texas
      • Houston, Texas, United States, 77008
        • Houston Eye Associates
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • The Eye Institute of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.
  • Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

  • 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.
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPO Pro IOL
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
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.
Other Names:
  • Clareon PanOptix Pro
  • Model PXYWT0
Device: CPO IOL
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.
Other Names:
  • Model CNWTT0
  • Clareon PanOptix
Procedure: Cataract surgery
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.
Active Comparator: CPO IOL
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
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.
Other Names:
  • Clareon PanOptix Pro
  • Model PXYWT0
Device: CPO IOL
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.
Other Names:
  • Model CNWTT0
  • Clareon PanOptix
Procedure: Cataract surgery
Extraction of the cataractous lens by phacoemulsification, followed by implantation of the IOL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
Time Frame: Month 2 postoperative
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Principal Clinical Trial Lead, Surgical, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2024

Primary Completion (Actual)

December 13, 2024

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

May 2, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILQ137-C002-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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