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

Last updated: March 11, 2025
Sponsor: Gainesville Eye Associates
Overall Status: Completed

Phase

N/A

Condition

Eye Disease

Eye Disorders/infections

Vision Loss

Treatment

Clareon Monofocal

Light-Adjustable Lens

Clinical Study ID

NCT06122103
CB-23-02
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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- correctedvisual outcomes of 20/25 or better

  • Regular corneal astigmatism of 0.75D-2.50D

  • Dilated pupil diameter of 7mm or greater

Exclusion

Exclusion Criteria:

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 maculardisease and other retinal degenerative diseases that is expected to cause futurevision loss, glaucoma, severe dry eye disease, history of uveitis, ocular herpessimplex 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 orthat 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.

Study Design

Total Participants: 138
Treatment Group(s): 2
Primary Treatment: Clareon Monofocal
Phase:
Study Start date:
November 21, 2023
Estimated Completion Date:
February 10, 2025

Connect with a study center

  • Gainesville Eye Associates

    Gainesville, Georgia 30501
    United States

    Site Not Available

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