跳至主要内容
临床试验/NCT00603850
NCT00603850已完成不适用

Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients

Notal Vision Ltd.1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
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 a 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: 1 month

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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