Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06629649
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glaucoma screening using an AI-algorithm and screening for diabetic retinopathy, cataract, and visual acuity impairment. — OTHER
    Participants who have the glaucoma screening will undergo an Artificial Intelligence Remote Optic Nerve Assessment (AI-RONA). The AI information may or may not be used by the FQHC provider to refer their patient for follow-up eye exam. It is information that the provider may find useful in making a referral.

Study Details

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.

Key Dates

Start date
Oct 22, 2025
Status verified
Dec 2025
Primary completion
Sep 29, 2029
Completion
Sep 29, 2029

Study Design

Enrollment
1,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING

Arms

  • Experimental: The Federally Qualified Health Centers (FQHCs)
    Eight FQHCs will participate in this project. Four FQHCs will implement a glaucoma screening protocol and a protocol for detecting diabetic retinopathy, cataract, and visual acuity impairment, while the other four will be standard of care without the above screening protocol.
  • No Intervention: Primary Standard of Care
    Primary care provider asks participants if they are having symptoms or problems with their eyes or vision.

Primary Outcome Measure

Rate of participants where the glaucoma screening protocol leads to a screening diagnosis of glaucoma [ Time Frame: up to 2-3 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Ophthalmology and Visual Sciences, University of Alabama at BirminghamBirminghamAlabama35294-0009
Dawn Matthies, PhD
[email protected]
205-325-8631
Mitzi Swift, BS
[email protected]
205-461-4003
Cynthia Owsley, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham· Birmingham, AL

Related Studies