Reading Center - Occurence of Diabetic Macular Edema in Patients With Diabetes Mellitus in Slovak Republic

• Conditions: Diabetic Retinopathy; Diabetic Macular Edema

• Registration Number: NCT02063321
• Lead Sponsor: Emil Martinka

Brief Summary

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.

Detailed Description

Epidemiological study, prospective, non-interventional

1. Patient with history of diabetes ≥ 10 years or with suspected visual impairment will be enrolled and screened in NIED during hospitalization

2. Anamnesis and history of diabetes, other co-morbidities, treatment will be recorded

3. Patient undergo in NIED detailed diabetology examination and basic ophthalmology examination (best non-corrected visual acuity in ETDRS score and Amsler grid test)

4. 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

5. 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.

Study Timeline

• Study Start: 2012-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-11
• Study First Submitted QC: 2014-02-12
• Last Update Submitted: 2014-02-12
• Study First Posted: 2014-02-14
• Last Update Posted: 2014-02-14
• Primary Completion: 2015-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 762

Inclusion Criteria

• 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

Exclusion Criteria

• Non-compliant patients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Diabetic Macular Edema or clinically significant Diabetic Macular Edema	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

Secondary Outcome Measures

Name	Time	Method
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
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 duration of diabetes	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