BACKGROUND Diabetic retinopathy (DR) is the leading cause of blindness in type 1 Diabetes Mellitus (DM) patients, as a consequence of impaired blood flow in the retina. Optical coherence tomography angiography (OCTA) is a newly developed, non-invasive, retinal imaging technique that permits adequate delineation of the perifoveal vascular network. It allows the detection of paramacular areas of capillary non perfusion and/or enlargement of the foveal avascular zone (FAZ), representing an excellent tool for assessment of DR. The relationship of these microvascular changes with systemic factors such as metabolic control or duration of the disease still needs to be elucidated. METHODS Prospective, consecutive, large-scale OCTA study. A complete ocular examination including a comprehensive series of OCTA images of different scan sizes captured with 2 OCT devices (Cirrus HD-OCT, Carl Zeiss Meditec, Dublin, CA, USA, and Triton Deep Range Imaging OCT, Topcon Corp, Topcon, Japan) will be obtained as part of the yearly routine follow up visits in type 1 DM patients seen in the Diabetes Unit of the Endocrinology department which give written informed consent to participate in the project. The aim of this study is to investigate the relationship between OCTA-derived parameters and systemic factors, as metabolic control (Hb1Ac, lipid profile, cholesterol, etc), and other relevant clinical factors as demographics or duration of the disease. DISCUSSION This study is directed to investigate the relationship between the status of the perifoveal vascular network and systemic markers of the disease, and in particular to study whether these changes reflect those occurring elsewhere in the body affected by diabetic microvascular disease, as the kidneys or the brain. If these relationships were demonstrated, early detection of these microvascular changes by OCTA could lead to modifications in the pharmacological management of type 1 diabetic patients, as a way to reduce the risk of future complications in both the eye and other organs. TRIAL REGISTRATION ClinicalTrials.gov, trial number NCT03422965.

中文翻译：

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使用光学相干断层扫描血管造影术（OCTA）对I型糖尿病的小凹周围血管网络中的微血管变化进行评估：一项大规模的前瞻性试验。

背景技术糖尿病性视网膜病（DR）是1型糖尿病（DM）患者失明的主要原因，这是由于视网膜中血流受损所致。光学相干断层扫描血管造影（OCTA）是一种新近开发的，非侵入性的视网膜成像技术，可充分描绘黄斑周血管网络。它可以检测毛细血管非灌注的黄斑旁区域和/或中心凹无血管区域（FAZ）的增大，是评估DR的极佳工具。这些微血管变化与系统性因素如代谢控制或疾病持续时间之间的关系仍需要阐明。方法前瞻性，连续，大规模的OCTA研究。完整的眼科检查，包括使用2种OCT设备（Cirrus HD-OCT，Carl Zeiss Meditec，美国都柏林，美国，以及Triton深度成像OCT，Topcon公司，Topcon，日本）捕获的一系列不同扫描尺寸的OCTA图像。将作为对内分泌学部门糖尿病科的1型DM患者进行年度例行随访的一部分，这些患者在获得知情同意后才能参与该项目。这项研究的目的是研究OCTA衍生参数与系统性因素之间的关系，例如代谢控制（Hb1Ac，脂质分布，胆固醇等），以及其他相关的临床因素（如人口统计学或疾病持续时间）。讨论本研究旨在研究黄斑中央凹血管网络状态与疾病全身标志之间的关系，尤其是研究这些变化是否反映了糖尿病微血管疾病影响的身体其他部位（如肾脏或肾脏）的​​变化。脑。如果这些关系得到证实，则通过OCTA早期发现这些微血管变化可能会导致1型糖尿病患者的药理学管理发生改变，从而降低眼部和其他器官未来发生并发症的风险。试验注册ClinicalTrials.gov，试验编号NCT03422965。如果这些关系得到证实，则通过OCTA早期发现这些微血管变化可能会导致1型糖尿病患者的药理学管理发生改变，从而降低眼部和其他器官未来发生并发症的风险。试验注册ClinicalTrials.gov，试验编号NCT03422965。如果这些关系得到证实，则通过OCTA早期发现这些微血管变化可能会导致1型糖尿病患者的药理学管理发生改变，从而降低眼部和其他器官未来发生并发症的风险。试验注册ClinicalTrials.gov，试验编号NCT03422965。