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

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

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.

Inclusion Criteria:

• 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 Criteria:

• 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