NCT00776451已完成不适用
Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The proportion of subjects who successfully completed the test by themselves, in a home simulated environment
研究概览
简要总结
To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.
详细描述
The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（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
- •Age ≥65 years
- •VA with habitual correction better than 20/60 in the study eye
- •Ability to speak, read and understand instructions in English or Hebrew
- •Qualified to use the device by health care professional
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 or macular surgery performed within 3 months prior to study entry in the target eye
- •Participation in another study with the exclusion of AREDS study
- •Patients diagnosed with geographic atrophy (GA)
结局指标
主要结局
The proportion of subjects who successfully completed the test by themselves, in a home simulated environment
时间窗: 2 clinic visits
次要结局
未报告次要终点
研究者
研究点 (1)
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