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 (DIARET SK)

Novartis

Status: Completed

Conditions: Diabetic Macular Edema; Diabetes Mellitus; Diabetic Retinopathy

Treatments: Genetic: Studied cohort

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02232503

CRFB002DSK01

Details and patient eligibility

About

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.

Enrollment: 4,011 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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