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| ID | Type | Description | Link |
|---|---|---|---|
| sukls117945/2024 | Other Identifier | SUKL |
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A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device
A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using the SWaMD medical device and the SWaMD comparator, when evaluating the patients retinal image
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one arm - 1000 patients, DR screening | Experimental | SW as medical devices(investigational device) to evaluate the retinal image of the patient's eye (to identify if the patient has DR or if the patient is healthy) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SW as medical devices(comperator) to evaluate the retinal image of the patient's eye (to identify if the patient has DR or if the patient is healthy) . | Device | second AI medical device to evaluate the retinal image of the patient's eye. two AI as MD will be evaluating the retinal image |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity | The sensitivity and specificity will be calculated using the evaluation of independent masked expert (ophthalmologist) as gold standard. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pavlina Kasparova Walter, MBA | Contact | 776661512 | 00420 | pavlinakasparova@gmail.com |
| Jiřà Tomšej, ING | Contact | 777108402 | 00420 | tomsej@viderai.com |
| Name | Affiliation | Role |
|---|---|---|
| Petr Å onka, MD | GP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jakub Sedivy | Recruiting | PÅ™Ãbram | Or | Czechia |
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specific screening exhamination
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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