Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Cynthia Owsley, PhD
cynthiaowsley@uabmc.edu
205-325-8635
Backup
Dawn Matthies, PhD
dmatthies@uabmc.edu
205-325-8631
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2029-09-29
Participants
Target number of participants: 1800
Treatments
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.
Sponsors
Collaborators: Centers for Disease Control and Prevention, University of California, San Diego
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov

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