NCT00596388已完成不适用
Usage of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of subjects who manage to use the device as in a daily testing
研究概览
简要总结
Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.
详细描述
The pilot study purpose is to demonstrate that the tutorial which is part of the device software, is giving sufficient training for the intended users.
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
- •Age >50 years
- •VA with habitual correction >20/60 in the study eye
- •Ability to speak, read and understand instructions in 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
- •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 manage to use the device as in a daily testing
时间窗: 6 month
次要结局
未报告次要终点
研究者
研究点 (1)
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