Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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

Qualifiers

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

Disqualifiers

Declines to sign written informed consent

Cannot communicate in English

Trial design

Treatments tested in this trial

  • Glaucoma screening using an AI-algorithm and screening for diabetic retinopathy, cataract, and visual acuity impairment.

Treatment groups

1,800 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

Centers for Disease Control and Prevention

Collaborator

University of California, San Diego

Collaborator