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Monofocal IOL Visual Outcomes When Targeting Mini Monovision

NCT05069415 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-02-13

Study results available
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Summary

This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.

Conditions

Interventions

DEVICE

Eyhance IOL

Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.

DEVICE

Eyhance IOL

Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.

Sponsors & Collaborators

  • Carolina Eyecare Physicians, LLC

    lead OTHER

Principal Investigators

  • Kerry D Solomon · Carolina Eyecare Physicians

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2022-11-30
Completion
2022-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05069415 on ClinicalTrials.gov