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
- Conditions
- Diabetic Retinopathy
- Registration Number
- NCT00763802
- Lead Sponsor
- Association for Innovation and Biomedical Research on Light and Image
- 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 Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and LDL levels, established on a set of 52 diabetic patients, will be tested on a population of 400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at 6-month interval (V0 and V6) to classify each patient into one of the 3 previously established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of end-points, achieved by the patients, are expected to validate our predictive model.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CSME needing Photocoagulation 24 months
- Secondary Outcome Measures
Name Time Method Vision Loss 24 months
Trial Locations
- Locations (1)
AIBILI
🇵🇹Coimbra, Portugal