Fundus Image-guided Focal Electroretinography, Usability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Maculaser Oy
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Signal-to-noise ratio of focal electroretinography signal
研究概览
简要总结
The purpose of this study is to investigate the usability of fundus image-guided focal electroretinography device with healthy subjects and with macular edema and macular degeneration patients.
详细描述
In this study, we will study the usability of focal electroretinography device combined with slit lamp biomicroscope. The device allows simultaneous fundus imaging and focal ERG recording from the desired retinal area.
In phase I, the usability of the investigational device is tested with 10 healthy volunteers. The examinations include focal ERG and noise tests with commercial ERG electrodes. The stimulus lights are guided to the fundus using either non-contact of contact fundus lens. One electrode is selected for phase II based on signal-to-noise ration, usability, and comfort.
In phase II, fundus image-guided focal ERG recordings are conducted with total of 10 patients having either macular edema or macular degeneration. The aim of the phase II is to test whether the investigational device can be used to record focal ERG signal from the desired symptomatic retinal area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers with no signs of macular edema or macular degeneration (phase I)
- •Patients with either macular edema or macular degeneration (phase II)
- •Able to give informed consent
排除标准
- •Epileptic patients
- •Vulnerable population: pregnant and breastfeeding women, underage, prisoners, persons with physical handicaps or mental disabilities, and disadvantaged persons.
结局指标
主要结局
Signal-to-noise ratio of focal electroretinography signal
时间窗: Through study completion, an average of 1 year
Signal-to-noise ratio of the focal ERG signals with different ERG electrodes.
Focal ERG from symptomatic retinal area
时间窗: Through study completion, an average of 1 year
Explore the device feasibility in recording focal ERG signal from areas with macular edema or macular degeneration.
次要结局
- Patient comfort and usability of different ERG electrodes in focal ERG.(Through study completion, an average of 1 year)