Artificial Intelligence for Diabetic Retinopathy
(DRES POCAI Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byFatima A Muñoz, MD,MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Centro De Salud La Comunidad De San Ysidro Inc DBA: San Ysidro Health

No Placebo Group

Trial Summary

What is the purpose of this trial?This research study is being conducted to improve eye care by using artificial intelligence (AI) to make diabetic eye screenings faster and more accessible. AI technology mimics human decision-making, enabling computers and systems to analyze medication information. Specifically for this screening, AI examines digital images of the eye and based on that information, may identify if a participant has diabetic retinopathy. It can assist doctors in making decisions about a participant's diagnosis, treatment or care plans to improve patient care. This is a collaboration between San Ysidro Health (SYHealth), University of California, San Diego (UC San Diego), and Eyenuk. The Kaiser Permanente Augmented Intelligence in Medicine and Healthcare Initiative (AIM-HI) awarded SYHealth funds to demonstrate the value of AI technologies in diverse, real-world settings.

Eligibility Criteria

This trial is for individuals with diabetic retinopathy or herpes simplex retinopathy. Participants will have their eye images analyzed by AI to identify signs of disease. The study aims to make eye screenings quicker and more widely available.

Inclusion Criteria

I have been diagnosed with diabetes.

Established and active patient of SYHealth-CV and KC (having a medical appointment in the last 18 months).

I have a medical appointment scheduled during the study period.

+4 more

Exclusion Criteria

I do not have a mental condition that prevents me from consenting to the study.

I have had diabetic retinopathy, macular edema, or a blocked blood vessel in my eye.

Pregnant women.

+2 more

Participant Groups

The intervention being tested is an artificial intelligence system that screens for diabetic retinopathy by analyzing digital images of the eyes. This study evaluates the effectiveness of AI in aiding diagnosis and treatment plans.

2Treatment groups

Experimental Treatment

Active Control

Group I: Diabetic Retinopathy ScreeningExperimental Treatment1 Intervention

The intervention group will complete the DR screening using a special camera and the AI system (EyeArt®), the same day of the study visit. Participants assigned to the intervention group will also receive a retinal screening without dilation using the EyeArt® AI system; the DR screening will be completed before their medical provider visits. The results will be available immediately after the screening, allowing participants to learn about and discuss their eye health with their care provider.

Group II: Usual careActive Control1 Intervention

The usual care group will complete the DR screening with an eye care provider on a different day and at a different location. The study staff will facilitate this process for participants in the usual care group by assisting them in scheduling appointments for their routine retinal screening.