An observational study in Diabetic Macular Edema and Diabetic Retinopathy, sponsored by Emil Martinka. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-14.
Sponsored by Emil Martinka · Observational
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.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 762 is above the median of 97 across 163 observational studies indexed under Macular Edema.
Browse Macular Edema studies →This is the only study on the registry with Emil Martinka as lead sponsor.
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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).
Exclusion Criteria:
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
Time frame: Patients screened during hospitalization in National Institute of Endocrinology and Diabetology (NIED), usually in 10 days
Patient´s structure with DME and clinically significant DME in terms of demography and anamnesis of diabetes
Time frame: Patients screened during hospitalization in NIED, usually in 10 days
Range of visual deterioration and occurence of blindness in relation to duration of diabetes
Time frame: Patients screened during hospitalization in NIED, usually in 10 days
Prognostic factors, which determine the occurence of DME using explorative analysis
Time frame: Patients screened during hospitalization in NIED, usually in 10 days
Range of visual deterioration and occurence of blindness in relation to type of diabetes
Time frame: 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)
Time frame: Patients screened during hospitalization in NIED, usually in 10 days
No study locations are listed for this record.
This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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