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 (CPM)

Association for Innovation and Biomedical Research on Light and Image

Status: Completed

Conditions: Diabetic Retinopathy

Study type: Observational

Funder types: Other

Identifiers

NCT00763802

PTDC/SAU-OSM/72635/2006

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

MNPDR

Description:

Type 2 diabetic patients with Mild non-prolipherative retinopathy.