Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06629649

Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers

Led by University of Alabama at Birmingham · Updated on 2025-12-29

1800

Participants Needed

1

Research Sites

205 weeks

Total Duration

On this page

Sponsors

U

University of Alabama at Birmingham

Lead Sponsor

C

Centers for Disease Control and Prevention

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if implementation of an eye screening program at Federally Qualified Health Center (FQHC) clinics provides results that participants may have glaucoma, and/or other eye conditions (diabetic retinopathy, cataract, visual acuity impairment). The glaucoma screening will incorporate use of an artificial intelligence (AI)-assisted screening tool. This project is called AI-RONA. The main questions it aims to answer are: * How does this eye screening program compare to the rate of glaucoma and other eye conditions detected at other FQHC clinics where the screening program has not been implemented? * Do particpants who screen positive for these conditions adhere to the physician's recommendation for a follow-up examination by an optometrist or ophthalmologist? * Are referral rates for a follow-up comprehensive eye exam by an optometrist or ophthalmologist similar to those implemented by an ophthalmologist using telemedicine (that is, using the results of the screening to make a diagnosis remotely)? * What is the cost-effectiveness of the AI-assisted screening program in diagnosing glaucoma as compared to a physician-guided program? * Are participants completing the screening satisfied with it? * Are physicians at the FQHC clinics administering the screening satisfied with it? Participants will: * Undergo an ocular screening whose goal is to detect glaucoma, diabetic retinopathy, cataract, and/or impairment in visual acuity. If the screening indicates that participants may have these conditions, participants will be referred for a comprehensive eye examination by an optometrist or ophthalmologist. * Following the screening, participants and physicians will complete a survey on their satisfaction with the program.

CONDITIONS

Official Title

Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • African American or Hispanic persons 40 years old or older
  • Non-Hispanic white persons 50 years old or older
  • Anyone 18 years old or older with type 1 or type 2 diabetes
  • Anyone 18 years old or older who already has a glaucoma associated disease
  • Anyone 18 years old or older with a family history of glaucoma
Not Eligible

You will not qualify if you...

  • Declines to sign written informed consent
  • Cannot communicate in English

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294-0009

Actively Recruiting

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Research Team

C

Cynthia Owsley, PhD

CONTACT

D

Dawn Matthies, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SCREENING

Number of Arms

2

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