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Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The latter will be achieved by administering a questionnaire to PCPs and to participants about their satisfaction with the screening program."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an eye screening program that uses artificial intelligence (AI) at community health centers. It checks for glaucoma, a disease that damages the eye’s nerve, and other eye problems. It is for adults who meet certain age and race or ethnicity rules, or who have diabetes, a glaucoma-related disease, or a family history of glaucoma.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You meet at least one of these rules:
  • You are African American or Hispanic and age 40 or older.
  • You are non-Hispanic white and age 50 or older.
  • You are age 18 or older and have type 1 or type 2 diabetes.
  • You are age 18 or older and already have a disease linked to glaucoma.
  • You are age 18 or older and have a family history of glaucoma.

Who can't join

  • You do not agree to sign a form giving your informed consent to join the study.
  • You cannot communicate in English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

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