Clareon PanOptix Pro vs. Clareon PanOptix - Study A

NCT ID: NCT06400745

Last Updated: 2025-12-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-18

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aphakia Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Contralateral (split face) study design
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

CPO Pro IOL

Intervention Type 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.

CPO IOL

Intervention Type 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.

Cataract surgery

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

CPO Pro IOL

Intervention Type 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.

CPO IOL

Intervention Type 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.

Cataract surgery

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Cataract surgery

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

Intervention Type PROCEDURE

Other Intervention Names

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Clareon PanOptix Pro Model PXYWT0 Clareon PanOptix Model CNWTT0

Eligibility Criteria

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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.

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.
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Principal Clinical Trial Lead, Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

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Wolstan & Goldberg Eye Associates

Torrance, California, United States

Site Status

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

Bloomfield Hills, Michigan, United States

Site Status

Moyes Eye Center

Kansas City, Missouri, United States

Site Status

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Site Status

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, United States

Site Status

Vision for Life

Nashville, Tennessee, United States

Site Status

Houston Eye Associates

Houston, Texas, United States

Site Status

The Eye Institute of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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ILQ137-C002-A

Identifier Type: -

Identifier Source: org_study_id

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