Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy
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
- 是
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
David Huang
Thomas Hwang, MD, Professor of Ophthalmology, Retina & Vitreous Diseases Division
Oregon Health and Science University
