Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Trial ID: NCT06629649
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-10-22
Completion date: 2029-09-29
Sponsor: University of Alabama at Birmingham
Collaborators: Centers for Disease Control and Prevention; University of California, San Diego
Conditions: Glaucoma; Ocular Hypertension
Interventions: Glaucoma screening using an AI-algorithm and screening for diabetic retinopathy, cataract, and visual acuity impairment.
Locations: Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham
Countries: United States
Enrollment: 1800
Age range: 18 Years - None
Sex: ALL

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

Outcomes:
Rate of participants where the glaucoma screening protocol leads to a screening diagnosis of glaucoma; Rate of participants who decide to attend the follow up exam by optometrist or ophthalmologist; Rate of participants where the screening protocol leads to a screening diagnosis of cataract, diabetic retinopathy, or visual acuity impairment; Compare cost of screening program in FQHC to the cost of an ophthalmologist or optometrist guided assessment