RecruitingPhase 4NCT07693205

A Prospective, Randomized, Subject- and Examiner-Masked, Multicenter Study Comparing Bilateral Clareon TruPlus and Bilateral Clareon Monofocal Intraocular Lens Implantation (Spherical and Toric) in Cataract Subjects


Sponsor

Berkeley Eye Center

Enrollment

180 participants

Start Date

Jun 12, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This investigator-initiated trial is a prospective, randomized, parallel-group, bilateral implantation study comparing Clareon TruPlus versus Clareon monofocal intraocular lenses (IOLs). Spherical and toric models are permitted in both arms based on standardized preoperative planning and clinical indication. Subjects and postoperative examiners/technicians will be masked to IOL assignment; surgeons will not be masked. The overall structure is modeled after randomized bilateral implantation cataract study designs with a Month 3 primary endpoint visit.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Clareon TruPlus and a medical device called Clareon monofocal for people with cataract. The study is currently recruiting participants at 1 location. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEClareon TruPlus

Bilateral implantation with Clareon TruPlus

DEVICEClareon monofocal

Bilateral implantation with Clareon monofocal


Locations(1)

Berkeley Eye Center - Sugar Land

Sugar Land, Texas, United States

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NCT07693205


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