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Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens | Clinical Trials | Clareo Health

COMPLETED

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

NCT06122103•Gainesville Eye Associates

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.
•Adult patients undergoing age-related cataract surgery with expected best- corrected visual outcomes of 20/25 or better
•Regular corneal astigmatism of 0.75D-2.50D
•Dilated pupil diameter of 7mm or greater

Exclusion Criteria

•Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, history of uveitis, ocular herpes simplex virus, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
•History of corneal refractive and intraocular surgery.
•Patients taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina.
•The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.
•Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Locations (1)

Gainesville Eye Associates

Gainesville, Georgia, United States

Key Dates

Start Date

November 21, 2023

Primary Completion Date

February 10, 2025

Completion Date

February 10, 2025

Last Updated

January 28, 2026

Enrollment

138

ACTUAL participants

Conditions

Cataract

Interventions

Clareon Monofocal

DEVICE

Light-Adjustable Lens

DEVICE

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NCT06979752

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

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RECRUITING

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

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Cataract Surgery

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

IC-8 Apthera IOL New Enrollment Post Approval Study

HUD Surgical Guidance for Toric Alignment

PRO-232 in Patients Subjected to Cataract Surgery

Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery