MedTrace Logo

Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens

NCT06122103 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2026-01-28

Study results available
· View outcomes & findings →

Summary

This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.

Conditions

  • Cataract

Interventions

DEVICE

Clareon Monofocal

Clareon Monofocal Intraocular Lens (toric and non-toric)

DEVICE

Light-Adjustable Lens

Light-Adjustable Lens (Intraocular Lens)

Sponsors & Collaborators

  • Sengi

    collaborator INDUSTRY

  • Gainesville Eye Associates

    lead OTHER

Principal Investigators

  • Clayton G Blehm, MD · Gainesville Eye Associates

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2025-02-10
Completion
2025-02-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06122103 on ClinicalTrials.gov