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Artificial Intelligence

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

N/A
Waitlist Available
Led By Cynthia Owsley, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
African American or Hispanic persons ≥ 40 years old
Non-Hispanic white persons ≥ 50 years old
Must not have
Cannot communicate in English
Declines to sign written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if implementing an eye screening program at health centers can help detect eye conditions like glaucoma, diabetic retinopathy, and cataracts. They will use an artificial intelligence

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since this trial involves non-invasive screening rather than medication or surgery, there are no direct side effects from the intervention itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am African American or Hispanic and 40 years old or older.
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I am a non-Hispanic white person aged 50 or older.
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I am 18 or older with a glaucoma diagnosis.
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I am 18 or older with type 1 or type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to communicate in English.
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I choose not to sign the consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Compare cost of screening program in FQHC to the cost of an ophthalmologist or optometrist guided assessment
Rate of participants where the glaucoma screening protocol leads to a screening diagnosis of glaucoma
Rate of participants where the screening protocol leads to a screening diagnosis of cataract, diabetic retinopathy, or visual acuity impairment
+1 more
Secondary study objectives
Rate of participants who state they agree with the acceptability of the screening intervention
Rate of primary care provider who state they agree with intervention acceptability, appropriateness, and feasibility

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Centers for Disease Control and PreventionFED
885 Previous Clinical Trials
21,991,087 Total Patients Enrolled
5 Trials studying Glaucoma
3,794 Patients Enrolled for Glaucoma
University of Alabama at BirminghamLead Sponsor
1,634 Previous Clinical Trials
2,303,329 Total Patients Enrolled
7 Trials studying Glaucoma
2,589 Patients Enrolled for Glaucoma
University of California, San DiegoOTHER
1,170 Previous Clinical Trials
1,570,155 Total Patients Enrolled
12 Trials studying Glaucoma
4,940 Patients Enrolled for Glaucoma
~1200 spots leftby Sep 2027
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