N/A N=138

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

Cataract

Bottom Line

View on ClinicalTrials.gov: NCT06122103 ↗

Enrolled (actual)

138

Serious AEs

0.0%

Results posted

Jan 2026

Primary outcome: Primary: Binocular Corrected Distance Visual Acuity (CDVA) — -0.03; -0.03 logMAR

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Clareon Monofocal (Device); Light-Adjustable Lens (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gainesville Eye Associates
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Binocular Corrected Distance Visual Acuity (CDVA)	-0.03; -0.03	—
SECONDARY Binocular Uncorrected Distance Visual Acuity (UDVA)	0.02; 0.03	—
SECONDARY Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)	0.17; 0.11	—
SECONDARY Binocular Uncorrected Intermediate Visual Acuity (UIVA)	0.06; 0.04	—
SECONDARY Monocular Corrected Distance Visual Acuity (CDVA)	-0.01; 0.01; 0.02; 0.01	—
SECONDARY Monocular Uncorrected Distance Visual Acuity (UDVA)	0.05; 0.08; 0.28; 0.26	—
SECONDARY Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)	0.26; 0.23; 0.25; 0.22	—
SECONDARY Monocular Uncorrected Intermediate Visual Acuity (UIVA)	0.30; 0.22; 0.11; 0.08	—

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06122103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.