Recruiting

AI-RONA

Sponsor:

University of Alabama at Birmingham

Code:

NCT06629649

Conditions

Glaucoma

Ocular Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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

Study ID

NCT06629649

Start date

Oct 22, 2025

Status verified date

Dec, 2025

Completion date

Sep 29, 2029

Anticipated

Primary completion date

Sep 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1800 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Screening

Interventions and Outcome Measures

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.

Interventions

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 measure

  • Rate of participants where the glaucoma screening protocol leads to a screening diagnosis of glaucoma [ Time Frame: up to 2-3 days ]
  • Rate of participants who decide to attend the follow up exam by optometrist or ophthalmologist [ Time Frame: up to 4 months ]
  • 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 ]
  • Compare cost of screening program in FQHC to the cost of an ophthalmologist or optometrist guided assessment [ Time Frame: up to 4 years ]

Central Contacts and Locations

Central contacts

Cynthia Owsley, PhD

205-325-8635cynthiaowsley@uabmc.edu

Dawn Matthies, PhD

205-325-8631dmatthies@uabmc.edu

Locations

Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294-0009

Contacts

Dawn Matthies, PhD

205-325-8631dmatthies@uabmc.edu

Mitzi Swift, BS

205-461-4003Mswift@uabmc.edu

Principal Investigator:

Cynthia Owsley, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Keywords

  • visual acuity impairment
  • glaucoma
  • ocular hypertension
  • glaucoma suspect
  • diabetic retinopathy
  • cataract

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-12-29.