AI-based glaucoma and eye disease screening at federally qualified health centers
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
This project will test whether an AI-assisted eye screening program at federally qualified health centers can find glaucoma and other eye problems (like diabetic retinopathy and cataracts) and whether people follow up with an eye doctor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06629649 on ClinicalTrials.gov |
What this trial studies
The program implements AI-assisted imaging to screen for glaucoma, diabetic retinopathy, cataract, and visual acuity impairment at Federally Qualified Health Centers (FQHCs) and compares detection and referral outcomes with FQHCs that do not use the program. Participants receive imaging-based screening and are referred for comprehensive eye exams when the AI or graders flag potential disease. Outcomes include disease detection rates, referral rates, and patient adherence to follow-up recommendations, and referral patterns are compared with an ophthalmologist-guided telemedicine workflow. The protocol adapts methods from a prior telemedicine program (AL-SIGHT) and targets higher-risk, underserved populations served by FQHCs.
Who should consider this trial
Good fit: Ideal candidates are adults at higher risk—African American or Hispanic people aged 40 or older, non-Hispanic white people aged 50 or older, and anyone 18 or older with diabetes, a glaucoma-associated disease, or a family history of glaucoma.
Not a fit: People who cannot consent or cannot communicate in English, and those already receiving regular specialty eye care, may receive little or no additional benefit from this screening program.
Why it matters
Potential benefit: If successful, the program could increase early detection of glaucoma and other eye conditions and improve access to follow-up eye care for underserved patients.
How similar studies have performed: Previous telemedicine screening programs such as AL-SIGHT have demonstrated feasibility in FQHC populations and AI tools have shown effectiveness for diabetic retinopathy screening, but AI-based glaucoma screening is less established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama
- Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Cynthia Owsley, PhD — University of Alabama at Birmingham
- Study coordinator: Cynthia Owsley, PhD
- Email: cynthiaowsley@uabmc.edu
- Phone: 205-325-8635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.