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NCT06879834 | RECRUITING | Diabetic Retinopathy

Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
Sponsor:

The Filatov Institute of Eye Diseases and Tissue Therapy

Information provided by (Responsible Party):

Andrii Korol, MD, PhD

Brief Summary:

To examine the potential for the detection of diabetic retinopathy (DR) using the artificial intelligence (AI)-based software platform Retina-AI.

Condition or disease

Diabetic Retinopathy

Intervention/treatment

taking fundus photos using non-mydriatic fundus camera

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, operator uploaded fundus images in the AI system for processing by the neural network.

Study Type : OBSERVATIONAL
Estimated Enrollment : 200 participants
Official Title : Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
Actual Study Start Date : 2024-11-02
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening

Location Details

NCT06879834

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Locations

RECRUITING

Ukraine,

The Filatov Institute of Eye Diseases and Tissue Therapy

Odessa, Ukraine, 65061