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NCT07502456NARecruiting

Clareon TruPlus Study

Alcon Research

Start Date

5/26/2026

Completion Date

6/1/2028

Summary

The purpose of this research study is to generate safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses (IOLs). IOLs are medical devices that are implanted in the eye during cataract surgery to restore clear vision after the cloudy natural lens has been removed. IOLs are intended to remain in the eyes for the duration of the patient's lifetime.

Detailed Description

In this study, subjects will be implanted with Clareon TruPlus Monofocal IOLs. The IOL to be implanted (Non-Toric or Toric) will be based on the recommendation of an IOL calculator. Subjects will attend 8 study visits, including one preoperative visit, two surgical visits, and five postoperative visits. The second eye surgery will occur 0-14 days after the first eye surgery. The total duration of a subject's participation in the study will be approximately 13 months.

Eligibility Criteria

Age Range: 22 years to No maximum

Key Inclusion Criteria: * Diagnosed with bilateral cataracts and planned bilateral cataract extraction by routine phacoemulsification. * Potential postoperative BCDVA of 0.2 logMAR or better in each eye in the expert medical opinion of the investigator. * Astigmatism suitable for correction with available toric IOL models. * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Age-related macular degeneration (AMD), glaucoma, diabetic retinopathy, and other eye conditions as specified in the protocol. * Moderate to severe dry eye that would affect study measurements. * Other protocol-specified exclusion criteria may apply.

Interventions

DEVICE

Clareon TruPlus Monofocal Non-Toric IOL

DEVICE

Clareon TruPlus Monofocal Toric IOL

PROCEDURE

Phacoemulsification

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Conditions

AphakiaAstigmatism

Locations

Eye Doctors of Arizona

Phoenix, Arizona 85028

United States

Cleveland Eye Clinic

Brecksville, Ohio 44141

United States

Carolina Eyecare Physicians LLC

Mt. Pleasant, South Carolina 29464

United States

Berkeley Eye Center

Sugar Land, Texas 77478

United States

The Eye Institute of Utah

Salt Lake City, Utah 84107

United States