NCT06629649 Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
| NCT ID | NCT06629649 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,800 participants |
| Start Date | 2025-10-22 |
| Primary Completion | 2029-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,800 participants in total. It began in 2025-10-22 with a primary completion date of 2029-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Declines to sign written informed consent * Cannot communicate in English
Contact & Investigator
Cynthia Owsley, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06629649 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06629649 currently recruiting?
Yes, NCT06629649 is actively recruiting participants. Contact the research team at cynthiaowsley@uabmc.edu for enrollment information.
Where is the NCT06629649 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06629649 clinical trial?
NCT06629649 is sponsored by University of Alabama at Birmingham. The principal investigator is Cynthia Owsley, PhD at University of Alabama at Birmingham. The trial plans to enroll 1,800 participants.