Reading Center - Occurence of Diabetic Macular Edema in Patients With Diabetes Mellitus in Slovak Republic
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 762
- 主要终点
- Prevalence of Diabetic Macular Edema or clinically significant Diabetic Macular Edema
研究概览
简要总结
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.
详细描述
Epidemiological study, prospective, non-interventional
- Patient with history of diabetes ≥ 10 years or with suspected visual impairment will be enrolled and screened in NIED during hospitalization
- Anamnesis and history of diabetes, other co-morbidities, treatment will be recorded
- Patient undergo in NIED detailed diabetology examination and basic ophthalmology examination (best non-corrected visual acuity in ETDRS score and Amsler grid test)
- Patient undergo in NIED examination of the back of the eye using fundus camera to take images of retina to assess long-term changes of macula, optic disc, retina vessels and surrounding tissues
- The assessment of the ophthalmology examination will be carried out in one of two specialized reading centers - II. Eye Clinic SZU FNsP F.D.R., Banská Bystrica or OFTAL Specialized Hospital for Ophthalmology, Zvolen by Retina specialist
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults ≥18 years treated in National Institute of Endocrinology and Diabetology
- •Patients diagnosed with Diabetes mellitus type I and type 2 respectively
- •Presence of Diabetes ≥10 years or patients with suspected visual impairment (duration of diabetes <10 years)
- •Signed patient´s information and informed content
排除标准
- •Non-compliant patients
结局指标
主要结局
Prevalence of Diabetic Macular Edema or clinically significant Diabetic Macular Edema
时间窗: Patients screened during hospitalization in National Institute of Endocrinology and Diabetology (NIED), usually in 10 days
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
次要结局
- 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(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)
研究者
Emil Martinka
Head of Diabetology Department
National Institute of Endocrinology and Diabetology, Slovakia