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| Name | Class |
|---|---|
| Novartis Slovakia, s.r.o. | INDUSTRY |
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The aim of the study is to find out prevalence of diabetic macular edema (DME) in patients with diabetes mellitus in Slovak Republic.The outcome of the project will be epidemiology survey, prevalence of wet form of Diabetic Macular Edema in relation to duration of diabetes, type of diabetes, treatment (insulin vs. OAD or combination) etc. and identification of prognostic factors leading to development of DME.
Epidemiological study, prospective, non-interventional
The process of screening will be continuous, whilst each patient will sign an informed consent.
Patients records will be stored electronically and data transmission between NIED and Reading Center will be protected using validated and secured software.
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Diabetic Macular Edema or clinically significant Diabetic Macular Edema | Image of fundus taken in NIED securely sent via internet and electronic Clinical Report Form (eCRF) to ophthalmology reading center to assess stage and severity of potential retina damage, feedback to NIED within the stay of screened individual essential for further disease management | Patients screened during hospitalization in National Institute of Endocrinology and Diabetology (NIED), usually in 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient´s structure with DME and clinically significant DME in terms of demography and anamnesis of diabetes | Patients screened during hospitalization in NIED, usually in 10 days | |
| Range of visual deterioration and occurence of blindness in relation to duration of diabetes |
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Inclusion Criteria:
Exclusion Criteria:
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Adults regularly examined in National Institute of Endocrinology and Diabetology (NIED) for their severity and complications of diabetes will undergo a screening procedure using fundus camera to assess the back of the eye (fundus examination).
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| Name | Affiliation | Role |
|---|---|---|
| Marta Ondrejkova, MD | II. Eye Clinic SZU of F.D.Roosevelt Hospital, Banska Bystrica | Study Chair |
| Monika Gajdosova, MD | Oftal, s.r.o. Specialized Hospital for Ophthalmology, Zvolen | Study Chair |
| Emil Martinka, MD | Department of Diabetology of National Institute for Endocrinology and Diabetology, Lubochna | Principal Investigator |
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| Label | URL |
|---|---|
| Main Site of Principal Investigator | View source |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| Patients screened during hospitalization in NIED, usually in 10 days |
| Prognostic factors, which determine the occurence of DME using explorative analysis | Patients screened during hospitalization in NIED, usually in 10 days |
| Range of visual deterioration and occurence of blindness in relation to type of diabetes | Patients screened during hospitalization in NIED, usually in 10 days |
| Range of visual deterioration and occurence of blindness in relation to general treatment (insulin vs. OAD or combination therapy) | Patients screened during hospitalization in NIED, usually in 10 days |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |