RecruitingNCT06879834

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


Sponsor

The Filatov Institute of Eye Diseases and Tissue Therapy

Enrollment

200 participants

Start Date

Nov 2, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

  • 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 Criteria2

  • 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.
  • \. 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.

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Interventions

DEVICEtaking fundus photos using non-mydriatic fundus camera

using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.


Locations(1)

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, Ukraine

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NCT06879834


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