跳至主要内容
临床试验/NCT03422965
NCT03422965Unknown不适用

Evaluation of Microvascular Changes in the Perifoveal Vascular Network Using Optical Coherence Tomography Angiography (OCT-A) in Type I Diabetes Mellitus

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2017年5月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
600
试验地点
2
主要终点
Perifoveal vessel density

研究概览

简要总结

This study is directed to evaluate the role of Optical Coherence Tomography Angiography (OCT-A) in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between OCT-A-derived parameters and demographic and clinical factors, as metabolic control and duration of the disease.

详细描述

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 (OCT-A) is a newly developed, non-invasive, retinal imaging technique that allows detection of perfused and non perfused areas of the retina without the injection of dye. This OCT-based method permits adequate delineation of the perifoveal vascular network, and allows objective identification of microvascular changes, such as capillary dilation or presence of microaneurisms. It is also capable to detect paramacular areas of capillary non perfusion and/or enlargement of the foveal avascular zone (FAZ), representing an excellent tool for assessment of diabetic retinopathy.

Given that all these features are commonly seen in diabetic patients, the relationship of these microvascular changes with systemic factors such as metabolic control or duration of the disease still need to be elucidated. Interestingly, further studies are required to investigate 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 could lead to modifications in the pharmacological management of diabetic patients, as a way to reduce the risk of future complications in both the eye and other organs. The aim of this study is to evaluate the role of OCT-A in the evaluation of the perifoveal vascular network in type 1 diabetic patients, and to investigate the relationship between these OCT-A-derived parameters and demographic and clinical factors, as metabolic control and duration of the disease.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Type 1 Diabetes Mellitus
  • •Healthy controls

排除标准

  • •Ocular pathologies other than diabetic retinopathy (i.e. age-related macular degeneration, retinal vein occlusions, uveitis, glaucoma, etc.)
  • •Axial length: <-6.00 to >+3.00 diopters
  • •Media Opacities
  • •Unability to capture OCT images

研究组 & 干预措施

Type 1 Diabetes Mellitus

Active Comparator

Cohort of Type 1 DM patients

干预措施: Optical Coherence Tomography Angiography (Diagnostic Test)

Type 1 Diabetes Mellitus

Active Comparator

Cohort of Type 1 DM patients

干预措施: Blood test (Diagnostic Test)

Type 1 Diabetes Mellitus

Active Comparator

Cohort of Type 1 DM patients

干预措施: Urine test (Diagnostic Test)

Healthy controls

Sham Comparator

Cohort of Healthy controls

干预措施: Optical Coherence Tomography Angiography (Diagnostic Test)

Healthy controls

Sham Comparator

Cohort of Healthy controls

干预措施: Blood test (Diagnostic Test)

Healthy controls

Sham Comparator

Cohort of Healthy controls

干预措施: Urine test (Diagnostic Test)

结局指标

主要结局

Perifoveal vessel density

时间窗: 24 months

OCTA images will be processed to obtain vascular density measurements in this area (mm-1)

次要结局

  • Parafoveal vessel density(24 months)
  • Total Avascular Area(24 months)
  • Foveal Avascular Zone(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Javier Zarranz-Ventura

MD, PhD, FEBO

Hospital Clinic of Barcelona

研究点 (2)

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