CHARACTERIZATION OF VASCULAR AND VOLUMETRIC STRUCTURAL CHANGES BY ANGIO OCT IN PATIENTS WITH DIABETIC MACULAR EDEMA TREATED WITH ANTIANGIOGENETICS AND DEXAMETHASONE IMPLANT.

Abstract

Introduction: Diabetic retinopathy (DR), a common ocular complication of diabetes, is the leading cause of low vision in diabetic patients, with diabetic macular edema (DME) being the primary cause of visual impairment in patients with diabetes mellitus. The pathogenesis of DME involves hypoxia, inflammation, and endothelial dysfunction. Optical Coherence Tomography (OCT) is an essential non-invasive tool that allows visualization and quantification of retinal and choroidal microvascular alterations associated with DME, including the foveal avascular zone (FAZ), vascular density, and tortuosity.

Objective: To characterize the vascular structural and volumetric changes by OCT in patients with diabetic macular edema treated with anti-angiogenic agents and dexamethasone implantation.

Methodology: This is a prospective study. Patients with DME receiving this combination treatment will be analyzed, evaluating Angio-OCT (Optovue) measurements before and one month after the intervention. Images will be analyzed to quantify foveal area (FAZ) diameter and area, foveal vascular density, central macular thickness, and macular cube volume. The sample size was calculated to detect a clinically relevant change; for example, approximately 32 participants are required for a 10-micron change. Statistical analysis will include descriptive statistics and normality tests (Shapiro-Wilk). Pre- and post-treatment comparisons will be made using the Student's t-test for related samples (Gaussian data) or the Wilcoxon signed-rank test for paired samples (non-Gaussian data). Correlations (Spearman or Pearson) and receiver operating characteristic (ROC) curves will be explored. The data will be managed in Microsoft® Excel 2016 and analyzed with GraphPad Prism 9.4.0, with a significance level of p<0.05. The Angio-OCT equipment is available in the ophthalmology department.