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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Retinopathy; Diabetic Macular Edema

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 Type: Observational
• Enrollment (Actual): 762

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults regularly examined in National Institute of Endocrinology and Diabetology (NIED) for their severity and complications of diabetes will undergo a screening procedure using fundus camera to assess the back of the eye (fundus examination).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of Diabetic Macular Edema or clinically significant Diabetic Macular Edema	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	Patients screened during hospitalization in National Institute of Endocrinology and Diabetology (NIED), usually in 10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Emil Martinka
• Collaborators: Novartis Slovakia, s.r.o.
• Investigators: Study Chair: Marta Ondrejkova, MD, II. Eye Clinic SZU of F.D.Roosevelt Hospital, Banska Bystrica; Study Chair: Monika Gajdosova, MD, Oftal, s.r.o. Specialized Hospital for Ophthalmology, Zvolen; Principal Investigator: Emil Martinka, MD, Department of Diabetology of National Institute for Endocrinology and Diabetology, Lubochna

Publications and helpful links

Helpful Links

• Main Site of Principal Investigator

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 12, 2014
• First Posted (Estimate): February 14, 2014

Study Record Updates

• Last Update Posted (Estimate): February 14, 2014
• Last Update Submitted That Met QC Criteria: February 12, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: DME, diabetic retinopathy, diabetes mellitus, epidemiology
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Degeneration; Macular Degeneration; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Macular Edema; Edema
• Other Study ID Numbers: LUB012013