Status:
RECRUITING
Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
Lead Sponsor:
The Filatov Institute of Eye Diseases and Tissue Therapy
Collaborating Sponsors:
CheckEye LLC
Oftacentro SA
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18-90 years
Brief Summary
To examine the potential for the detection of diabetic retinopathy (DR) using the artificial intelligence (AI)-based software platform Retina-AI.
Detailed Description
Operator took fundus images with a non-mydriatic fundus camera as per the Retina-AI CheckEye imaging protocol (an optic disc centered image and a fovea centered image for each eye).Thereafter, operato...
Eligibility Criteria
Inclusion
- Documented diagnosis of diabetes mellitus by definition.
- Understanding of the Study and willingness and ability to sign informed consent
- Patient age 18 or above
- Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes
Exclusion
- 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.
Key Trial Info
Start Date :
November 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06879834
Start Date
November 2 2024
End Date
December 1 2025
Last Update
March 17 2025
Active Locations (1)
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1
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, Ukraine, 65061