Using AI to screen for diabetic retinopathy
Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
This study tests if an AI program can accurately find signs of diabetic retinopathy in eye images taken from people with diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The Filatov Institute of Eye Diseases and Tissue Therapy Academic / other |
| Locations | 1 site (Odesa) |
| Trial ID | NCT06879834 on ClinicalTrials.gov |
What this trial studies
This study examines the effectiveness of an artificial intelligence-based software platform, Retina-AI, in detecting diabetic retinopathy (DR). Participants will have fundus images taken with a non-mydriatic camera, following a specific imaging protocol. These images will then be uploaded to the AI system for analysis by a neural network to assess the presence of DR. The goal is to evaluate the accuracy and reliability of this AI tool in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a documented diagnosis of diabetes mellitus.
Not a fit: Patients under 18, those unable to provide informed consent, or individuals with other retinal diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of diabetic retinopathy, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using AI for medical imaging, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Documented diagnosis of diabetes mellitus by definition. 2. Understanding of the Study and willingness and ability to sign informed consent 3. Patient age 18 or above 4. Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes Exclusion Criteria: -1. Patients under 18 years of age; 2. Failure to give informed consent; 3. Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc. 4\. A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.
Where this trial is running
Odesa
- The Filatov Institute of Eye Diseases and Tissue Therapy — Odesa, Ukraine (Recruiting)
Study contacts
- Principal investigator: Andrii MD Korol, PhD — The Filatov Institute of Eye Diseases and Tissue Therapy
- Study coordinator: Andrii MD Korol, PhD
- Email: andrii.r.korol@gmail.com
- Phone: 380936327266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.