Rebound Esthesiometer Phase 2 Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Rebound esthesiometer operating parameters
研究概览
简要总结
The purpose of this study is to define the operating parameters for a new method to measure corneal sensitivity.
详细描述
Corneal sensitivity is the most important protective mechanism of the eye. Thus, measuring it at any given time gives important indicators of corneal physiology, especially in the diagnostics of corneal and systemic diseases (e.g. diabetes, herpes simplex and keratitis) and recovery from ocular surgery. Current commercial measurement methods are outdated, non-quantitative and uncomfortable to use, hence left unused. This results in suboptimal, even poor, diagnosis and treatment for patients.
In this study the operating parameters for a state-of-the-art esthesiometer are defined. The operating principle is based on existing rebound technology which is already approved for IOP measurement.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 18
- •Informed consent signed
排除标准
- •Signs of infectious or inflammatory disease of anterior eye at the time of presentation.
- •During last two weeks, any of the following events or conditions occurred or was present: inflammatory or infectious ocular condition, surgical or other intervention or therapy, other abnormal ocular event.
- •Unable to give informed consent.
- •Directly or indirectly indicated vunerability.
结局指标
主要结局
Rebound esthesiometer operating parameters
时间窗: 2020-2021
Measure the correlation of corneal touch sensitivity between rebound esthesiometer and the reference instrument Cochet-Bonnet monofilament esthesiometer. With the rebound esthesiometer the impact is varied by changing the speed (m/s) of the measurement probe. The probe mass (mg) and speed (m/s) equals to the touch impact impulse which causes the touch sensation. The subjective sensation of the test subject is recorded.
Rebound esthesiometer operating threshold
时间窗: 2020-2021
Define the corneal touch sensitivity threshold using the rebound esthesiometer by varying the measurement probe impact at the moment of touch of corneal surface. The impact is varied by changing the speed (m/s) of the measurement probe and the subjective sensation of the test subject is recorded. The mass (mg) of the measurement probe is known and the impact energy is calculated.
次要结局
未报告次要终点