Diabetic Macular Edema, Diabetic Retinopathy
Conditions
Keywords
DME, diabetic retinopathy, diabetes mellitus, epidemiology
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.
Interventions
None listed
Sponsors
Novartis Slovakia, s.r.o.
Emil Martinka
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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 |
Outcome results
None listed