NCT06122103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

November 21, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2025

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 28, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

November 3, 2023

Results QC Date

November 27, 2025

Last Update Submit

January 26, 2026

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Binocular Corrected Distance Visual Acuity (CDVA)

    3 months postop

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Other Outcomes (7)

  • 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

  • +4 more other outcomes

Study Arms (2)

Clareon Monofocal

Device: Clareon Monofocal

Light-Adjustable Lens

Device: Light-Adjustable Lens

Interventions

Clareon MonofocalDEVICE

Clareon Monofocal Intraocular Lens (toric and non-toric)

Clareon Monofocal
Light-Adjustable LensDEVICE

Light-Adjustable Lens (Intraocular Lens)

Light-Adjustable Lens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gainesville Eye Associates

Gainesville, Georgia, 30501, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Clayton Blehm
Organization
North Georgia Eye Associates
claytonblehm@gmail.com
770-532-4444

Study Officials

  • Clayton G Blehm, MD

    Gainesville Eye Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 8, 2023

Study Start

November 21, 2023

Primary Completion

February 10, 2025

Study Completion

February 10, 2025

Last Updated

January 28, 2026

Results First Posted

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)