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临床试验/NCT02330042
NCT02330042进行中(未招募)不适用

Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy

Oregon Health and Science University1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2015年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
165
试验地点
1
主要终点
Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography

研究概览

简要总结

Diabetic retinopathy (DR) is caused by changes in the blood vessels of the retina associated with long-term Type 1 or Type 2 diabetes mellitus. DR is a leading cause of blindness in the United States. Standard optical coherence tomography (OCT) cannot directly detect vascular changes, which may occur early affecting the passage of blood through the tiny capillaries (reduced capillary flow) or cause the greatest damage through formation of abnormal blood vessel growth (neovascularization). Currently, fluorescein angiography (FA) is the gold standard for detecting these changes, but FA requires an injection of a dye into the vein of the arm of the patient. This dye can cause undesirable side effects. Recently, OCT has been used to make functional measurements (such as total retinal blood flow among others) and to perform angiography. Thus, functional OCT may provide a useful, alternate way to evaluate diabetic retinopathy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography

时间窗: 1 year

Neovascular membrane area will be measured in mm2.

Number of participants with measureable macular edema by OCT imaging

时间窗: 1 year

Retinal thickening area will be measured in mm2.

Number of participants with decreased total retinal blood flow by OCT angiography

时间窗: 1 year

Total retinal blood flow will be measured in uL/min.

次要结局

未报告次要终点

研究者

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

David Huang

Thomas Hwang, MD, Professor of Ophthalmology, Retina & Vitreous Diseases Division

Oregon Health and Science University

研究点 (1)

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