Clareon PanOptix Pro vs. Clareon PanOptix - Study B

Alcon Research71 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Aphakia Presbyopia

Interventions

CPO Pro IOLDEVICE

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.

CPO IOLDEVICE

Cataract Surgery

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Locations (8)

Wolstan & Goldberg Eye Associates

Torrance, California, United States

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

Bloomfield Hills, Michigan, United States

Moyes Eye Center

Kansas City, Missouri, United States

Cincinnati Eye Institute

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

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.

Time frame: Month 2 postoperative

Data from ClinicalTrials.gov

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