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

Completed

• Conditions: Cataract
• Interventions: Device: Clareon Monofocal; Device: Light-Adjustable Lens

• Registration Number: NCT06122103
• Lead Sponsor: Gainesville Eye Associates

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-08
• Study Start: 2023-11-21
• Primary Completion: 2025-02-10
• Study Completion: 2025-02-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clareon Monofocal	Clareon Monofocal	-
Light-Adjustable Lens	Light-Adjustable Lens	-

Primary Outcome Measures

Name	Time	Method
Binocular corrected distance visual acuity (CDVA)	3 months postop

Secondary Outcome Measures

Name	Time	Method
Binocular distance corrected intermediate visual acuity (DCIVA)	3 months postop
Binocular uncorrected distance visual acuity (UDVA)	3 months postop
Binocular uncorrected intermediate visual acuity (UIVA)	3 months postop
Monocular uncorrected distance visual acuity (UDVA)	3 months postop
Monocular distance corrected intermediate visual acuity (DCIVA)	3 months postop
Monocular corrected distance visual acuity (CDVA)	3 months postop
Monocular uncorrected intermediate visual acuity (UIVA)	3 months postop

Trial Locations

Locations (1)

Gainesville Eye Associates; 🇺🇸 Gainesville, Georgia, United States