Status:
COMPLETED
Identifying Progression of Retinal Disease in Eyes With NPDR in Diabetes Type 2 Using Non-invasive Procedures
Lead Sponsor:
European Vision Institute Clinical Research Network
Conditions:
Type 2 Diabetes
Non Proliferative Diabetic Retinopathy
Eligibility:
All Genders
35-75 years
Brief Summary
The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).
Detailed Description
To identify "progressors" in retinal vascular disease and central retinal edema in type 2 diabetic patients with early NPDR, based on retinal disease progression from baseline to the 12-month visit, a...
Eligibility Criteria
Inclusion
- Diabetes type 2 according to 1985 WHO criteria
- Age between 35 and 75 years
- Mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the ETDRS criteria) - 7 fields color fundus photography
- Presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 DA) - Field 2
- Best Corrected Visual Acuity \>= 75 letters (\>= 20 /32)
- Refraction with a spherical equivalent less than 5 Dp
- Informed consent
Exclusion
- Cataract or other eye disease that may interfere with fundus examinations
- Glaucoma
- Any eye surgery within a period of 6-months
- Other retinal vascular disease
- Previous laser therapy
- Dilatation of the pupil \< 5 mm
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT01145599
Start Date
September 1 2010
Last Update
February 11 2015
Active Locations (1)
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1
Centre for Clinical Trials- AIBILI - Association for Innovation and Biomedical Research on Light and Image
Coimbra, Coimbra District, Portugal, 3030-548