Automated detection of diabetic retinopathy lesions in fundus photos

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 validates the AI subsystem of the DDART medical device for automated detection of diabetic retinopathy lesions in retinal fundus images. It uses a random sample of high-quality color fundus photographs to measure how often the AI correctly identifies diabetic retinopathy and how well it distinguishes disease severity. The study compares the algorithm’s performance with assessments by experienced ophthalmologists and reports diagnostic accuracy, sensitivity, specificity, and ROC-AUC. No interventional treatment is administered; the focus is on diagnostic performance of the AI tool. Eligible participants are adults with available high-resolution fundus images, while images of poor quality or with interfering ocular diseases are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria Age ≥18 years Availability of a high-resolution color fundus photograph Confirmed diagnosis established by an ophthalmology specialist Exclusion Criteria Poor-quality retinal images Concomitant ocular diseases that interfere with image interpretation

Where it's running

• University Hospital of Alexandroupolis
  Alexandroupoli, Greece Recruiting

Study contacts

• Study coordinator: Georgios Labiris
• Email: glampiri@med.duth.gr
• Phone: +302551030990

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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.