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RECRUITING
NCT07693205
PHASE4

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

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-06-12

Completion Date

2027-07

Last Updated

2026-07-21

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Clareon TruPlus

Bilateral implantation with Clareon TruPlus

DEVICE

Clareon monofocal

Bilateral implantation with Clareon monofocal

Locations (1)

Berkeley Eye Center - Sugar Land

Sugar Land, Texas, United States