NCT06629649 · University of Alabama at Birmingham
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
(AI-RONA)
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Rate of participants where the glaucoma screening protocol leads to a screening diagnosis of glaucoma
Time frame: up to 2-3 days
Primary care provider will make a screening diagnosis of glaucoma associated disease based on the results of the screening
Rate of participants who decide to attend the follow up exam by optometrist or ophthalmologist
Time frame: up to 4 months
If diagnosed with any of the above conditions, and primary car provider recommends follow-up care with an optometrist or ophthalmologist, whether participant actually attends the exam
Rate of participants where the screening protocol leads to a screening diagnosis of cataract, diabetic retinopathy, or visual acuity impairment
Time frame: up to 2-3 days
Based on results of screening, the primary care provider will be able to make 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
Time frame: up to 4 years
Compare the cost of AI based interventions relying on optic disc photos alone, OCT alone, both imaging modalities, and imaging with standard vision tests performed by an ophthalmologist or optometrist guided program
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
Collaborators
Centers for Disease Control and Prevention, University of California, San Diego
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 29, 2025 · Source of record for eligibility and locations