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

Completed

Conditions studied: Cataract

In brief

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.

Key facts

Study ID

NCT06122103

Run by

Gainesville Eye Associates

People needed

138

Starts

2023-11-21

Expected to finish

2025-02-10

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
• 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.

Where it is running

• Gainesville Eye Associates — Gainesville, Georgia, United States

Full record on ClinicalTrials.gov

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