NCT06629649Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1800 (estimated)
- First submitted
- 30 Sept 2024
- Start date
- 22 Oct 2025
- Primary completion date
- 29 Sept 2029
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Glaucoma, High blood pressure, Diabetic eye disease
- NCT number
- NCT06629649
What you commit to
- Study type: Interventional
- Planned participants: 1800
- From 22 Oct 2025 to the primary completion date, 29 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Declines to sign written informed consent
- Cannot communicate in English
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.