Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: taking fundus photos using non-mydriatic fundus camera.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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, operator uploaded fundus images in the AI system for processing by the neural network.
Interventions
- Device taking fundus photos using non-mydriatic fundus camera
using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography.
Primary outcome measures
- The accuracy [Time frame: Baseline]
Secondary outcome measures (2)
- The percent of invalid images [Time frame: Baseline]
- The percent of false positive detection of DR [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Ukraine · 1 center
- The Filatov Institute of Eye Diseases and Tissue Therapy — Odesa
Identifiers
NCT: NCT06879834 · 02.10.2024