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临床试验/NCT03586505
NCT03586505已完成不适用

Tolerance to Light for Patients Suffering From Keratitis

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Light intensity

研究概览

简要总结

In order to develop an innovative device to study infectious keratitis, we need to illuminate the cornea of patients suffering from an infectious keratitis with red or near-infrared light. Because of technical reasons the shortest possible wavelength (red) presents advantages.

详细描述

The aim of this preliminary study is to measure the maximal intensity tolerated during illumination with 6 wavelength corresponding : 2 red, 2 far red and 1 near infrared lights in order to determine the shortest wavelength well tolerated by patients, in comparison with the standard blue light illumination.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •Social security insurance
  • •Suspected infectious keratitis (clinically defined. No lab testing required)
  • •Signed informed consent

排除标准

  • •Major Blepharospasm
  • •Aphakia (absence of lens)
  • •Pregnant woman
  • •Nursing mother

研究组 & 干预措施

Light exposure

Experimental

The keratitis eye of the patient is exposed to 6 lights with increasing intensity according to a constant speed.

The patients switch off the light when the discomfort is too elevated

干预措施: Light exposure (Device)

结局指标

主要结局

Light intensity

时间窗: At the inclusion

For each wavelength, the highest light intensity tolerated by the patient is measured (mWatts/cm² )

次要结局

  • Severity of the keratitis(At the inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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