Status:
COMPLETED
Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2
Lead Sponsor:
Association for Innovation and Biomedical Research on Light and Image
Collaborating Sponsors:
Fundação para a Ciência e a Tecnologia
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
35-75 years
Brief Summary
This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The Coimbra Predictive ...
Eligibility Criteria
Inclusion
- Diabetes type 2 according to 1985 WHO criteria.
- Age between 35 and 75 years.
- Mild non-prolipherative retinopathy (based on ETDRS criteria)
- Best Corrected Visual acuity \>20 /25
- Refraction with a spherical equivalent less than 5 Dp.
- Inform consent
Exclusion
- Cataract or other eye disease that may interfere with fundus examinations
- Glaucoma
- Vitreous syneresis or posterior vitreous detachment
- Other retinal vascular disease
- Recent intraocular surgery
- Previous laser therapy
- Dilatation of the pupil \< 5 mm
Key Trial Info
Start Date :
September 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00763802
Start Date
September 1 2007
End Date
May 1 2011
Last Update
April 7 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AIBILI
Coimbra, Coimbra District, Portugal, 3000-548