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| Name | Class |
|---|---|
| CheckEye LLC | INDUSTRY |
| Oftacentro SA | OTHER |
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To examine the potential for the detection of diabetic retinopathy (DR) using the artificial intelligence (AI)-based software platform Retina-AI.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| main group | have diabetes mellitus |
| |
| control group | have risk factors for developing diabetes mellitus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taking fundus photos using non-mydriatic fundus camera | Device | using artificial intelligence to identify diabetic retinopathy in the early stages using fundus photography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy | The accuracy of detecting of DR | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| The percent of invalid images | The percent of invalid images for analysing by neural network | Baseline |
| The percent of false positive detection of DR | The percent of false positive detection of DR in individuals without DR |
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Inclusion Criteria:
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.
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200 participants were planed to include in study, 100 of them had diabetes mellitus and 100 participants were as a control group have risk factors for diabetes mellitus.
All participants were selected for the study based on the following inclusion and exclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrii MD Korol, PhD | Contact | 380936327266 | andrii.r.korol@gmail.com | |
| Olha MD Pohosian | Contact | 380932084927 | olha.a.pohosian@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Andrii MD Korol, PhD | The Filatov Institute of Eye Diseases and Tissue Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Filatov Institute of Eye Diseases and Tissue Therapy | Recruiting | Odesa | 65061 | Ukraine |
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| Label | URL |
|---|---|
| Detecting diabetic retinopathy using an artificial intelligence-based software platform: a pilot study | View source |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| Baseline |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |