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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
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
Clareon TruPlus
Bilateral implantation with Clareon TruPlus
Clareon monofocal
Bilateral implantation with Clareon monofocal
Locations (1)
Berkeley Eye Center - Sugar Land
Sugar Land, Texas, United States