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ENROLLING BY INVITATION
NCT07589894

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

Sponsor: Colvard Kandavel Eye Center

View on ClinicalTrials.gov

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.

Official title: BMVDI Study: Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus IOL

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-05

Completion Date

2027-05

Last Updated

2026-05-26

Healthy Volunteers

No

Interventions

DEVICE

Clareon TruPlus IOL

A prospective, single-site, observational study evaluating binocular and monocular distance-corrected and uncorrected visual performance following bilateral implantation of the TruPlus intraocular lens (IOL). Both eyes will be targeted for emmetropia using Argos biometry with IOL power calculated by the Barrett Universal formula. Second-eye surgery will occur within 2 weeks of the first eye. Final evaluation will take place 12 weeks after second eye surgery.

Locations (1)

Colvard-Kandavel Eye Center

Encino, California, United States