Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers

Recruiting now · Not applicable

Conditions studied: Glaucoma, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT06629649

Run by

University of Alabama at Birmingham

People needed

1800

Starts

2025-10-22

Expected to finish

2029-09-29

Last updated by the study team

2025-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• African American or Hispanic persons ≥ 40 years old
• Non-Hispanic white persons ≥ 50 years old
• Anyone ≥ 18 years old with diabetes type 1 or type 2
• Anyone ≥ 18 years old who already has a glaucoma associated disease
• Anyone ≥ 18 years old with a family history of glaucoma

You may not qualify if…

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

Where it is running

• Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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