Diabetic Retinopathy, Type 1 Diabetes
Conditions
Keywords
OCT-A, OCT Angiography
Brief summary
The objective of the study is to evaluate the differences in the retinal microcirculation measured by OCT-Angiography in patients with type 1 diabetes between the diagnosis of the disease and after 3 months of insulin treatment.
Interventions
DIAGNOSTIC_TESTOptical Coherence Tomography (OCT) Angiography
Measurement of retinal vessel density and distribution in the macula using new generation OCT device
Sponsors
Hospital Arnau de Vilanova
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Type 1 Diabetes at diagnosis of the disease (less than 7 days after diagnosis) * Age equal to or greater than 18 years * Signature of the informed consent by the patient / legal guardian.
Exclusion criteria
* Metabolic situation of ketosis or ketoacidosis, according to clinical criteria established in the protocol of the Endocrinology and Nutrition Service. The patient will be a candidate once the ketonemia is absent (value \<1 mmol / L). * Previous diagnosis of dyslipidemia and any previous lipid-lowering treatment * Previous diagnosis of hypertension and any previous hypotensive treatment * Previous diagnosis of any form of cardiovascular disease, including heart failure. * Previous kidney disease, and presence of advanced kidney failure (estimated glomerular filtration rate \<60 ml / min) * Presence of diabetic retinopathy identifiable by conventional eye fundus or retinography, or other concomitant retinal vascular pathology (hypertensive retinopathy, venous occlusion, arterial obstruction, etc.) * History or presence of retinal pathology that may alter its structure and / or the validity of the measurements (retinal detachment, epiretinal membrane, high myopia -understood as an axial length greater than or equal to 26mm measured by IOL Master biometry-, neovascular membrane, choroidal tumors, etc.) * History of posterior uveitis or retinal vasculitis * Glaucoma and neuro-ophthalmological pathology that can alter the neuroretinal structures. * Refractive media opacity that prevents a correct acquisition of images and, therefore, their evaluation * Dementia or intellectual disability that prevent proper collaboration when acquiring images
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vessel density | 3 months | Density of retinal vessels and perfusion in the macula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vessel density | 6 months | Density of retinal vessels and perfusion in the macula |
Countries
Spain
Contacts
Primary ContactIgnacio Salvador, MD
Outcome results
None listed