Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers

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.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

OTHER

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

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.

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• University of California, San Diego

  collaborator OTHER

• University of Alabama at Birmingham

  lead OTHER

Principal Investigators

• Cynthia Owsley, PhD · University of Alabama at Birmingham

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-22

Primary Completion

2029-09-29

Completion

2029-09-29

Countries

• United States

Study Locations