Automated AI system to detect diabetic retinopathy in adults with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates an autonomous AI system that analyzes retinal images to detect diabetic retinopathy in adults with diabetes. The software is a medical device intended to operate without human input for imaging-based screening. The study uses real-world retinal images to determine how accurately the AI identifies findings consistent with diabetic retinopathy. No active treatment is given; the focus is on detection performance and workflow integration. Recruitment is limited to adults at or above 22 years, with diabetes, at the Rovia Site Network in Jacksonville, FL.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 22 years of age or older
* Diagnosis of DM
* Ability to understand and willing to sign a written ICF

Exclusion Criteria:

Participants may be excluded if they have significant ocular conditions or prior ocular treatments that could interfere with retinal imaging or study assessments; are currently participating in another interventional ophthalmic clinical trial; have medical conditions that may affect study participation or data interpretation; are pregnant; or have contraindications to study-related imaging procedures.

Where it's running

• Rovia Site Network
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Audrey Singh Singh
• Email: singh@digitaldiagnostics.com
• Phone: 7633702127

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Diabetic retinopathy prevalence and risk factors at a Da Nang hospital

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  Recruiting Da Nang Family General Hospital · Da Nang · NCT07468058

• AI-assisted retinal photo screening for adults with diabetes

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  Recruiting VUNO Inc. · Incheon, Gyeonggi-do · NCT07378956

• New-generation diabetes medicines and the onset of diabetic retinopathy

  This study will test whether newer diabetes medicines (SGLT2 and DPP‑4 inhibitors) can delay diabetic retinopathy in people with type 2 diabetes who've had the disease for more than five years and have been on diabetes medications for 2–3 years.

  Recruiting Alexandria University · Alexandria · NCT07351786

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.