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

Part of paid clinical trials in Encino, California.

Sponsor
Colvard Kandavel Eye Center
Study ID
NCT07589894
Status
Enrolling By Invitation

Conditions

  • Cataract
  • Cataract (Post-operative Cataract Surgery Follow-up)
  • Cataract Bilateral
  • Cataract Surgery

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Clareon TruPlus IOL — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
50 participants (estimated)

Primary Outcome Measure

Binocular distance-corrected intermediate visual acuity (DCIVA) and Logarithm of the Minimum Angle of Resolution (logMAR) at 66cm at 12 weeks after second eye surgery [ Time Frame: Baseline and 12 weeks after second eye surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Colvard-Kandavel Eye CenterEncinoCalifornia91316-

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By research site
Colvard-Kandavel Eye Center· Encino, CA

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