Diabetic Retinopathy
Conditions
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.
Interventions
None listed
Sponsors
Fundação para a Ciência e a Tecnologia
Association for Innovation and Biomedical Research on Light and Image
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CSME needing Photocoagulation | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Vision Loss | 24 months |
Countries
Portugal
Outcome results
None listed