Clinical Trial

Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus Intraocular Lens (IOL)

Study acronym: BMVDI
Enrolling by Invitation
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Summary
This study aims to generate data that characterizes visual outcomes, including the binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm or defocus behavior, of the Clareon TruPlus modified monofocal intraocular lens (IOL). Clareon TruPlus IOL is designed to provide an extended range of vision compared to the parent monofocal IOL. Clareon TruPlus IOL delivers excellent intermediate vision without compromising distance vision including the quality of vision with low incidence of visual disturbances in normal cataract patients. Binocular distance-corrected intermediate visual acuity at 66cm will be assessed at a pre-specified postoperative interval 12 weeks after second eye surgery. This study hypothesizes that Clareon TruPlus IOL delivers good binocular DCIVA at 66cm 12 weeks after second eye surgery.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-05-27
Trial Details
NCT Number NCT07589894
Lead Sponsor Colvard Kandavel Eye Center
Conditions Cataract, Cataract Surgery, Cataract Bilateral, Cataract (Post-operative Cataract Surgery Follow-up)
Enrollment 50 participants
Start Date 2026-05
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-05-26