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

NCT07589894 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-05-26

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • Colvard Kandavel Eye Center

    lead OTHER

Principal Investigators

  • Ganesha R Kandavel, MD · Coilvard-Kandavel Eye Center

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07589894 on ClinicalTrials.gov