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

Association for Innovation and Biomedical Research on Light and Image400 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Diabetic Retinopathy

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes