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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-21

Study Completion Date

2025-02-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clareon Monofocal

Intervention Type DEVICE

Clareon Monofocal Intraocular Lens (toric and non-toric)

Light-Adjustable Lens

Intervention Type DEVICE

Light-Adjustable Lens (Intraocular Lens)

Interventions

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Clareon Monofocal

Clareon Monofocal Intraocular Lens (toric and non-toric)

Intervention Type DEVICE

Light-Adjustable Lens

Light-Adjustable Lens (Intraocular Lens)

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes