Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Proportion of subjects who managed to set the device
研究概览
简要总结
The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.
详细描述
Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable and willing to sign a consent form and participate in the study
- •Subjects diagnosed as intermediate AMD in at least one eye (in case a patient will convert during the study period he will be excluded)
- •Age more than 50 years
- •VA with habitual correction better than 20/60 in the study eye
- •Ability to speak, read and understand instructions in English or Hebrew
- •Familiar with computer usage
排除标准
- •Evidence of macular disease other than AMD or glaucoma in the study eye
- •Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
- •Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
- •Never been tested on the PHP device
- •Participation in another study with the exclusion of AREDS study
- •Patients diagnosed with geographic atrophy (GA)
结局指标
主要结局
Proportion of subjects who managed to set the device
时间窗: 6 months
Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training
时间窗: 6 month
Number of device malfunctions
时间窗: 6 month
Average use of the device
时间窗: 6 month
次要结局
未报告次要终点