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临床试验/NCT04014933
NCT04014933已完成不适用

Prospective, Non-randomised, Non-controlled Study of Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System

University of Zurich1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
intraclass correlation coefficients (ICCs)

研究概览

简要总结

In addition to intraocular pressure blood perfusion pressure in the optic nerve is an important factor determing the cause of glaucoma. Increasing evidence suggests that in glaucoma patients retinal blood may be decreased.

详细描述

According to the World Health Organization (WHO) glaucoma is the second leading cause of blindness. Glaucoma is a global problem, which is becoming even more important as the human life expectancy increases. Although the causes of glaucoma are uncertain, mainly intraocular pression (IOP), genetics, and ocular blood perfusion pressure in the optic nerve determine the cause of the disease. Increasing evidence suggests that in glaucoma patients retinal blood flow is decreased leading to progression and to damage of the optic nerve.

In order to measure the peripapillary blood flow a variety of devices using different techniques of flowmetry have been developed. In this study, the reproducibility of the retinal flowmetry measured with the LSFG-NAVI device from Nidek will be investigated. A high reproducibility is crucial for the clinical value of any measuring device.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • signed Patient Informed Consent form
  • Be at least 18 years old
  • Diagnosis of primary or secondary open-angle glaucoma or normal tension glaucoma or healthy controls

排除标准

  • Age < 18 years
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
  • No vulnerable participants will be included in this study.

结局指标

主要结局

intraclass correlation coefficients (ICCs)

时间窗: 1 month

Intraobserver ICC, interobserver ICC, and inter-session ICC will be computed

Coefficients of variation (COV)

时间窗: 1 month

COVs from 3 measurements of ocular blood flow at visit 1 of observer 1 and at visit 1 of observer 1 and from observer 2 will be computed.

次要结局

  • Cofounder(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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