NCT01443585Unknown不适用
Clinical Performance Evaluation of a Progressive Addition Lens Among Presbyopic Patients
Ziv Hospital0 个研究点目标入组 100 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Horizontal Intermediate Visual Field
研究概览
简要总结
The purpose of the trial is to clinically evaluate the performance of a progressive addition lens among presbyopic patients.
This evaluation will be done by performing visual tests and collecting subjective information from subjects wearing the lens which will be manufactured according to personal prescription.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An ability to comprehend and give an informed consent for participation in the trial
- •Presbyopia
排除标准
- •Concurrent participation in another clinical trial
- •For female subjects: pregnancy \ planning a pregnancy \ lactating at the time of enrollment
- •Imbalanced diabetes \ high blood pressure \ thyroid disease
- •Infectious disease
- •Inability (cognitively) to comprehend the instructions given during the trial and to comply with them
结局指标
主要结局
Horizontal Intermediate Visual Field
时间窗: Baseline
Visual Acuity
时间窗: Baseline
Horizontal Near Visual Field
时间窗: Baseline
Field of comfortable reading on a computer screen
时间窗: Baseline
Horizontal Far Visual Field
时间窗: Baseline
次要结局
- Subjective Evaluation of Visual Quality(2-3 weeks)
- Overall Subjective Feedback(2-3 weeks)
研究者
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