Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers

NCT06629649 | Recruiting

• 2 other identifiers: IRB-3000134251U01DP006827-01
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Rate of participants where the glaucoma screening protocol leads to a screening diagnosis of glaucoma

  Primary care provider will make a screening diagnosis of glaucoma associated disease based on the results of the screening

  up to 2-3 days

• Rate of participants who decide to attend the follow up exam by optometrist or ophthalmologist

  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

  up to 4 months

• Rate of participants where the screening protocol leads to a screening diagnosis of cataract, diabetic retinopathy, or visual acuity impairment

  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

  up to 2-3 days

• Compare cost of screening program in FQHC to the cost of an ophthalmologist or optometrist guided assessment

  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

  up to 4 years

Secondary Outcomes (2)

• Rate of primary care provider who state they agree with intervention acceptability, appropriateness, and feasibility

  up to 6 months

• Rate of participants who state they agree with the acceptability of the screening intervention

  up to 1 day

Study Arms (2)

The Federally Qualified Health Centers (FQHCs)

EXPERIMENTAL

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.

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

Primary Standard of Care

NO INTERVENTION

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. 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.

The Federally Qualified Health Centers (FQHCs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Declines to sign written informed consent
• Cannot communicate in English

Sponsors & Collaborators

• Centers for Disease Control and Prevention: collaborator
• University of California, San Diego: collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

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

Birmingham, Alabama, 35294-0009, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Diabetic Retinopathy; Cataract

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Eye Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Cynthia Owsley, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Owsley, PhD

CONTACT

205-325-8635; cynthiaowsley@uabmc.edu

Dawn Matthies, PhD

CONTACT

205-325-8631; dmatthies@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The initial design implements the eye screening intervention in 4 FHQC clinics operated by Southeast Alabama Rural Health Associates (SARHA) for a duration of 18 months. Four other FQHC clinics operated by SARHA are the control, or non-interventional clinics, which are followed during the same time period. After 18 months the control clinics become the interventional clinics and the previous intervention clinics become the control clinics.

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 8, 2024
• Study Start: October 22, 2025
• Primary Completion (Estimated): September 29, 2029
• Study Completion (Estimated): September 29, 2029
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: September 29, 2029
• Access Criteria: Scientists who work in the field of glaucoma screening and other types of eye screening will be able to access the supporting information described above. They can access this information by contacting the principal investigator.

Locations

US (1)