NCT05968365已完成不适用
Clinical Trial of the Safety and Effectiveness of Vision Pro Electronic Blind Aid Device
Wicab Technologies (Beijing) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2021年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- obstacle identification
研究概览
简要总结
To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and obstacle recognition for visually blind people
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 (including 18 and 65 years old)；
- •Visually impaired people；
- •Primary blind and visually impaired people
- •visual acuity is no light ~ < 0.02；
- •visual field radius less than 5°);
排除标准
- •. Allergic to nickel or stainless steel;
- •epileptic seizures;
- •pregnant women； 4.、implanted with electronic medical devices ；
- •5、 intellectual disability ； 6、 mental illness; 7、 Oral diseases； 8、oral ulcers, herpes, herpes simplex, oral thrush and map tongue； 9、 speech dysfunction, 10、limited mobility and hearing impairment;
结局指标
主要结局
obstacle identification
时间窗: 40 minutes
The success rate of obstacle identification
次要结局
- obstacle avoidance test(40 minutes)
研究者
研究点 (1)
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