Actively Recruiting
Assessing Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
Led by The Filatov Institute of Eye Diseases and Tissue Therapy · Updated on 2025-03-17
200
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
T
The Filatov Institute of Eye Diseases and Tissue Therapy
Lead Sponsor
C
CheckEye LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an artificial intelligence (AI) software platform called Retina-AI to detect diabetic retinopathy (DR), a complication of diabetes that affects the eyes. The study includes adults aged 18 to 90 who have diabetes mellitus or risk factors for developing diabetes. The goal is to assess the accuracy of this AI tool in identifying DR from eye images. During the study, participants will have fundus photos taken of their eyes using a non-mydriatic fundus camera, which does not require pupil dilation. Two images per eye are captured—one centered on the optic disc and one on the fovea. These images are then uploaded into the AI system, where a neural network processes them to detect signs of diabetic retinopathy. Participants will undergo imaging at the start of the study to provide baseline data. Researchers will measure the accuracy of the AI in detecting DR, including the percentage of invalid images and false positive results. The study is observational and involves no drug treatments. Participants' data will be collected and analyzed to evaluate the AI's performance in screening for diabetic retinopathy.
CONDITIONS
Brief Title
Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of diabetes mellitus
- Understanding of the study and willingness to sign informed consent
- Age 18 years or older
- Diagnosis of diabetes: either type 1 diabetes for at least 5 years or type 2 diabetes
You will not qualify if you...
- Under 18 years of age
- Unable or unwilling to give informed consent
- Presence of retinal diseases such as age-related macular degeneration, retinal vessel occlusion, coloboma of choroid or optic nerve, retinitis pigmentosa, or angioid streaks
- Previous treatment (surgery, laser, etc.) for any retinal disease, including age-related macular degeneration or retinal vascular occlusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo fundus photography using a non-mydriatic fundus camera, and images are processed by an artificial intelligence system to identify diabetic retinopathy in the early stages.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, Ukraine, 65061
Actively Recruiting
Research Team
A
Andrii MD Korol, PhD
O
Olha MD Pohosian
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here