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

NCT ID: NCT02063321

Last Updated: 2014-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 762 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Diabetic Macular Edema; Diabetic Retinopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Slovakia, s.r.o.

INDUSTRY

Sponsor Role: collaborator

Emil Martinka

OTHER

Sponsor Role: lead

Responsible Party

Emil Martinka

Head of Diabetology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marta Ondrejkova, MD

Role: STUDY_CHAIR

II. Eye Clinic SZU of F.D.Roosevelt Hospital, Banska Bystrica

Monika Gajdosova, MD

Role: STUDY_CHAIR

Oftal, s.r.o. Specialized Hospital for Ophthalmology, Zvolen

Emil Martinka, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Diabetology of National Institute for Endocrinology and Diabetology, Lubochna

Related Links

http://www.nedu.sk

Main Site of Principal Investigator

Other Identifiers

LUB012013

Identifier Type: -

Identifier Source: org_study_id