DIARET SK - Prevalence of Diabetic Retinopathy and Impact of Genetic Factors in the Development of Diabetic Retinopathy of Patients With Type 1 and 2 Diabetes Mellitus in Slovakia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,011
- 主要终点
- The prevalence of diabetic retinopathy as the proportion of patients with DR (any stage) in a given subgroup according to DM duration
研究概览
简要总结
The aim of the study is to find out prevalence and individual stages of Diabetic Retinopathy in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements in Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of diabetic retinopathy (DR) and diabetic macular edema (DME) in relation to type and duration of diabetes mellitus and risk factors. Project will also identify genetic factors linked with the diseases.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Signed informed consent for epidemiological research
- •Signed informed consent for genetic research
- •Patients with DM - type I and II regardless of the DM duration
- •All DM patients must be included regardless of presence of eye complications in patient´s anamnesis or during the examination by the diabetologist Subgroups analysis
- •Patients with DM - type I and II and DM duration ≥ 20 years
- •Patients with DM - type I and II and DM duration < 5 years and DR in history
排除标准
- •Age at the time of inclusion into the <18 years
- •Gestational DM or secondary-induced diabetes
- •Diabetic ketoacidosis or hyperosmolar coma
- •Alcohol abuse or acute alcohol intoxication
结局指标
主要结局
The prevalence of diabetic retinopathy as the proportion of patients with DR (any stage) in a given subgroup according to DM duration
时间窗: participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria
The results will be accompanied by Wald 95% confidence intervals. The combined prevalence results from more subgroups will be evaluated using weighted average using the best available epidemiology data.
次要结局
- Evaluate the prevalence and individual stages of Diabetic Retinopathy in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements(participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria)
- Evaluate the prevalence and individual stages of Diabetic Macular Edema (DME) in patients with type 1 and type 2 DM verified based on complex ophthalmologic measurements(participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria)
- Evaluate the impact of risk factors on the prevalence of Diabetic Retinopathy and Diabetic Macular Edema(participants screened each working day within 8 working hours during a 6 months period in selected diabetology centers according to protocol criteria)