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临床试验/NCT01717937
NCT01717937终止不适用

Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in the Imaging of Retinovascular Disease

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
1
主要终点
Measurement of to be determined physical characteristics of retinovascular structures seen on phase variance optical coherence tomography (PV-OCT) and fluorescein angiography(FA).

研究概览

简要总结

The purpose of this study is to determine whether phase variance optical coherence tomography (PV-OCT), a software-based optical coherence tomography(OCT) image processing technology, can be used to generate angiographic images of the retinochoroidal vasculature that are comparable to those produced by fluorescein angiography (FA), the current gold standard diagnostic test.

详细描述

Fluorescein angiography (FA) has long been the gold standard for vascular imaging of the retina and choroid. It is a test that involves the intravenous injection of fluorescein dye, followed by imaging of the dye's passage through the blood vessels inside the eye. It is commonly used to diagnose many forms of retinovascular disease, as well as to assess the retina's response to various therapeutic interventions. While FA is a relatively safe diagnostic test, it carries the risk of both minor and major side effects. These include nausea and vomiting, yellowing of the skin and urine, vascular extravasation with skin eruption and necrosis, vasovagal reactions, myocardial infarction, respiratory failure, anaphylaxis, cardiopulmonary arrest, and death. Additionally, the test is time-consuming, technically difficult to perform, and requires patients to undergo the discomfort associated with intravenous access. Despite these drawbacks, FA is still commonly used in clinical practice, as there are no existing alternative tests with the ability to provide comparable detail of the retinal and choroidal vasculature.

Phase-variance optical coherence tomography is a novel, noninvasive, software-based technology capable of generating angiographic images from the data gathered by standard OCT scans. Preliminary research suggests it can produce high-definition representations of the retinal and choroidal vasculature which may be more detailed than the images produced by FA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with suspected or established retinovascular disease who are going to undergo FA as part of their usual clinical evaluation.
  • Patients must be age 13 or above.
  • Patients must be able to speak and understand the English language in order to provide informed consent.

排除标准

  • Any patients who are unwilling to participate or provide informed consent.
  • Any patients who are pregnant at the time of enrollment.
  • Any patients with ocular media opacities which prevent clear evaluation of the fundus by either FA or OCT.

结局指标

主要结局

Measurement of to be determined physical characteristics of retinovascular structures seen on phase variance optical coherence tomography (PV-OCT) and fluorescein angiography(FA).

时间窗: On the day in which a patient receives PV-OCT and FA imaging, estimated to take 2 hours.

Masked examiners (retina specialists) will evaluate and grade coded PV-OCT and FA images for the presence and features of various retinovascular abnormalities (e.g., choroidal neovascular membranes, microaneurysms, venous dilation, etc.). Metrics to determined and may include: size, depth, area, volume, and relative position. Each subject's graded PV-OCT images will be compared to their graded FA images.

次要结局

  • Changes over time in the to be determined measured physical characteristics of retinovascular structures seen on PV-OCT and FA.(Up to 12 months after enrollment.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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