NCT01488786已完成不适用
A Study to Evaluate the Safety and Efficacy of the BrainPort® Vision Device in Subjects Who Are Blind
Wicab13 个研究点 分布在 2 个国家目标入组 75 人开始时间: 2011年10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
- 75
- 试验地点
- 13
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to assess the safety of the BrainPort vision device and to demonstrate improved object recognition and word identification and ambulation with use of the BrainPort vision device in subjects who are medically documented as blind, with acuity of 20/ 5000 or worse.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed written medical or low vision diagnosis of No Light Perception or Light Perception
- •Performance on the FrACT acuity test of worse than 20/5000 or impossible to measure.
- •Minimum post 6 months diagnosis blindness.
- •Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
- •Able to have read to him or her, understand, and sign the informed consent form.
- •Daily access to an accessible computer with email for study communication, device- use logging and access to device user manual preferred.
- •Willing and able to complete all testing, training, and follow- up evaluations required by the study protocol, after receiving a short orientation on the use of the device.
排除标准
- •Current oral health problems as determined from the oral health exam which preclude enrollment in the study in the judgment of the Principal Investigator.
- •Any medical condition that would interfere with performance on the assessments.
- •Prior use of the BrainPort vision device.
- •Known neuropathies of tongue or skin tactile system.
- •Smoke or chew tobacco products less than 12 months prior to study enrollment
- •Any allergies to nickel or stainless steel
- •History of seizures or epilepsy.
- •If female, pregnant. Women of child bearing potential must agree to use appropriate birth control to prevent pregnancy for the duration of the study.
- •People with implanted electrical medical devices (i.e. pacemaker, deep brain stimulator, cochlear implant).
- •Psychiatric disease including anxiety disorders and forms of depression (using provided Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI- II) as screening tools).
- •Any disease or condition that prevents understanding or communication of informed consent, study demands and testing protocols including the following:
- •Cognitive decline including forms of dementia and/or progressive neurological disease
- •Deafness or selective frequency hearing loss that prevents hearing device alarms and alerts.
- •Does not speak English
- •Blindness occurring due to cortical injury (i.e. stroke, traumatic brain injury, etc)
- •Principal Investigator, in his or her judgment, does not believe the subject is a good candidate for the trial.
结局指标
主要结局
Safety
时间窗: 1 year
The primary safety objective is to demonstrate that the rate of clinically significant device-related adverse events is less than 10%. This will require an observed event-free rate of approximately 97%.
Object Recognition
时间窗: 1 year
The primary efficacy objective is to demonstrate that at least 50% of subjects achieve a success rate in object recognition exceeding that expected by chance alone.
次要结局
- Word Identification(1 year)
- Ambulation/Mobility(1 year)
研究者
研究点 (13)
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