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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Clareon Monofocal; Device: Light-Adjustable Lens

• Study Type: Observational
• Enrollment (Actual): 138

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Gainesville, Georgia, United States, 30501
      • Gainesville Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Eligible participants will be adult normal astigmatic (≥ 0.75D corneal astigmatism) cataract patients presenting for cataract surgery who are considered appropriate candidates for intraocular lens implantation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clareon Monofocal	Device: Clareon Monofocal; Clareon Monofocal Intraocular Lens (toric and non-toric)
Light-Adjustable Lens	Device: Light-Adjustable Lens; Light-Adjustable Lens (Intraocular Lens)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular Corrected Distance Visual Acuity (CDVA)	3 months postop

Secondary Outcome Measures

Outcome Measure	Time Frame
Binocular Uncorrected Distance Visual Acuity (UDVA)	3 months postop
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)	3 months postop
Binocular Uncorrected Intermediate Visual Acuity (UIVA)	3 months postop
Monocular Corrected Distance Visual Acuity (CDVA)	3 months postop
Monocular Uncorrected Distance Visual Acuity (UDVA)	3 months postop
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)	3 months postop
Monocular Uncorrected Intermediate Visual Acuity (UIVA)	3 months postop

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular Distance-corrected Near Visual Acuity (DCNVA)		3 months postop
Binocular Uncorrected Near Visual Acuity (UNVA)		3 months postop
Monocular Distance Corrected Defocus Curve		3 months postop
Binocular Distance Corrected Defocus Curve		3 months postop
Manifest Refraction	MRSE, residual sphere, and residual astigmatism	3 months postop
Patient Reported Spectacle Usage Questionnaire (PRSIQ)	Participants are asked to indicate spectacle usage on a scale of "All of the time" to "None of the time" for distance, intermediate, and near vision.	3 months postop
Wavefront Aberrometry Using iTrace (Internal, Ocular, and Corneal Total Higher Order Aberrations)	Aberrometry was performed using the iTrace (Tracy Technologies, USA)	3 months postop

Collaborators and Investigators

• Sponsor: Gainesville Eye Associates
• Collaborators: Sengi
• Investigators: Principal Investigator: Clayton G Blehm, MD, Gainesville Eye Associates

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Actual): February 10, 2025
• Study Completion (Actual): February 10, 2025

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CB-23-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes