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临床试验/NCT04046523
NCT04046523招募中不适用

Non-Invasive and Non-Contact Intracranial Pressure Waveform Recording Using Dynamic Video Ophthalmoscopy

University of Minnesota2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
2
主要终点
The study will look at whether retinal video-recordings can be used to help estimate intracranial pressure.

研究概览

简要总结

This study will test the use of video ophthalmoscope to provide information about intracranial pressure without the use of invasive methods, anesthesia or contact with the eye.

详细描述

The monitoring of intracranial pressure (ICP) is crucial in head injuries and pathologies such as brain edema, arachnoid cyst, craniosynostosis or, in very-low-birthweight infants, post-hemorrhagic hydrocephalus. Some current methods of ICP are invasive and, in the case of lumbar puncture, require anesthesia, which can distort the measurement by 5-10 mmHg. The golden clinical standard is direct measurement using a surgically-implanted intraventricular drain connected to an external pressure transducer ("ICP probe"). However, this method carries risks such as hemorrhage, malfunction, obstruction or infection . The risk in pediatric patients is up to 5% and in adults the risk of fatal hemorrhage is 4-5% in patients with subdural and intraparenchymal monitoring devices. Due to these risks and the financial burden on patients, there have been attempts to develop tools for non-invasive ICP estimation. This study will test the use of a video ophthalmoscope that will calculate the relative waveform of intracranial pressure and provide information about intracranial compliance without the use of anesthesia, invasive methods or contact with the eye.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Must be able to sit still and fix their eyes on a target in the VO objective.
  • ICP participants must have an inserted ICP probe for clinical purposes.

排除标准

  • Diagnosis of glaucoma, retinopathy or head tremor.

结局指标

主要结局

The study will look at whether retinal video-recordings can be used to help estimate intracranial pressure.

时间窗: Participants in the Healthy Control and Intra-Group Verification arms will be enrolled for one day. Transfer Function Estimation Subjects will be enrolled for up to 14 days.

This study will help determine whether there could be a less invasive method of monitoring intracranial pressure. It is thought that the use of a video-ophthalmoscope recordings could be utilized to measure intracranial pressure. The outcome measures will be provided as z-scores.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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