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Artificial Intelligence

Artificial Intelligence for Diabetic Retinopathy (DRES POCAI Trial)

N/A

Recruiting

Led By Fatima Muñoz, MD, MPH

Research Sponsored by Centro De Salud La Comunidad De San Ysidro Inc DBA: San Ysidro Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Person aged 22 and older.

Established diagnosis of DM.

Must not have

Diagnosis of mental or degenerative disease that prevents self-consent for the study.

Prior diagnosis of DR, macular edema, or retinal vascular occlusion.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the enrollment (baseline) and through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to use artificial intelligence (AI) to improve diabetic eye screenings, making them quicker and more accessible. AI technology helps analyze digital images of the eye to identify diabetic retinopathy. This

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a non-invasive screening process using AI, there are no direct physical side effects associated with the technology itself as it's used to analyze data rather than treat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 22 years old or older.

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I have been diagnosed with diabetes.

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I understand the study details and can willingly consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had eye injections, laser retina treatment, or eye surgery (not including cataract surgery).

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I have ongoing vision problems in one or both eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the enrollment (baseline) and through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the enrollment (baseline) and through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and the enrollment (baseline) and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DM self-efficacy

DM self-management

DR Screening Satisfaction Survey (Intervention Group)

+5 more

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: 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.

0 / 7Eligibility criteria met