AI-Based Screening for Glaucoma
(AI-RONA Trial)

Recruiting in Palo Alto (17 mi)

Overseen byCynthia Owsley, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Cynthia Owsley, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for individuals at clinics where they might have glaucoma or other eye conditions like diabetic retinopathy and cataracts. It's designed to see if AI can help screen these issues effectively. Participants will be screened and possibly referred for further examination.

Inclusion Criteria

I am 18 or older with type 1 or type 2 diabetes.

I am African American or Hispanic and 40 years old or older.

I am over 18 and have a family history of glaucoma.

See 2 more

Exclusion Criteria

I am unable to communicate in English.

I choose not to sign the consent form.

Treatment Details

Interventions

AI-based Glaucoma Screening (Artificial Intelligence)

Trial OverviewThe study tests an AI-assisted screening tool called AI-RONA for detecting glaucoma and other eye conditions in health centers. It compares detection rates, follow-up adherence, referral rates, cost-effectiveness, and satisfaction with traditional methods.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: The Federally Qualified Health Centers (FQHCs)Experimental Treatment1 Intervention

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.

Group II: Primary Standard of CareActive Control1 Intervention

Primary care provider asks participants if they are having symptoms or problems with their eyes or vision.