Clinical trial NCT02063321: Reading Center - Occurence of Diabetic Macular Edema in Patients With Diabetes Mellitus in Slovak Republic
Official title: Reading Center - Occurence of Diabetic Macular Edema in Patients With Diabetes Mellitus in Slovak Republic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Macular Edema
Diabetic Retinopathy
Keywords: DME, diabetic retinopathy, diabetes mellitus, epidemiology
Lead sponsor: National Institute of Endocrinology and Diabetology, Slovakia
Sponsor class: OTHER
Collaborators: name: Novartis Slovakia, s.r.o.
First posted: 2014-02-14
Enrollment: 762
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Prevalence of Diabetic Macular Edema or clinically significant Diabetic Macular Edema
timeFrame: Patients screened during hospitalization in National Institute of Endocrinology and Diabetology (NIED), usually in 10 days
Secondary outcomes:
measure: Patient´s structure with DME and clinically significant DME in terms of demography and anamnesis of diabetes
timeFrame: Patients screened during hospitalization in NIED, usually in 10 days
measure: Range of visual deterioration and occurence of blindness in relation to duration of diabetes
timeFrame: Patients screened during hospitalization in NIED, usually in 10 days
measure: Prognostic factors, which determine the occurence of DME using explorative analysis
timeFrame: Patients screened during hospitalization in NIED, usually in 10 days
measure: Range of visual deterioration and occurence of blindness in relation to type of diabetes
timeFrame: Patients screened during hospitalization in NIED, usually in 10 days
measure: Range of visual deterioration and occurence of blindness in relation to general treatment (insulin vs. OAD or combination therapy)
timeFrame: Patients screened during hospitalization in NIED, usually in 10 days
Other outcomes:
Locations:
Study officials:
affiliation: II. Eye Clinic SZU of F.D.Roosevelt Hospital, Banska Bystrica
name: Marta Ondrejkova, MD
role: STUDY_CHAIR
affiliation: Oftal, s.r.o. Specialized Hospital for Ophthalmology, Zvolen
name: Monika Gajdosova, MD
role: STUDY_CHAIR
affiliation: Department of Diabetology of National Institute for Endocrinology and Diabetology, Lubochna
name: Emil Martinka, MD
role: PRINCIPAL_INVESTIGATOR
References: