NCT04725760Unknown不适用
Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population
Wicab7 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2020年10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
- 125
- 试验地点
- 7
- 主要终点
- Visual Function
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness and safety of the BrainPort® Vision Pro, an electronic oral assistive device, in the performance of daily tasks by French persons who have residual vision limited to light perception or less in both eyes.
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •8 years of age or older
- •Diagnosis of profound blindness with residual vision limited to a perception of light or lower in both eyes.
- •Minimum post 12 months diagnosis of blindness
- •Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
- •Ability to be read and to understand the documentation and procedures of the study.
- •Ability to provide feedback on the use of the BrainPort Vision Pro device.
- •Ability to use basic computer and/or other technologies.
- •Willing and able to answer all questionnaires, carry out telephone follow-ups, undergo device training and carry out all study procedures, after having passed the orientation phase with the device.
- •Participant or his legal representative willing and able to sign informed consent.
排除标准
- •Ongoing oral disorders determined on the basis of the participant's medical history and/or by an examination of the oral cavity by a dental specialist.
- •History of tongue damage resulting in sensitivity problems or impaired language.
- •Visible open sores, herpes, abrasions, blisters or rashes on the tongue or numbness of the tongue.
- •Piercings on the tongue.
- •Planned or recent oral surgery (in the last 3 months) and/or dental care (excluding oral check-ups or routine scaling).
- •Known neuropathy of the language or sensory system.
- •History of seizures or epilepsy.
- •Pregnant woman, willing to be pregnant or lactating. Women of childbearing age should consent to the use of appropriate contraception to avoid pregnancy during the study period.
- •Implanted medical devices (e.g., pacemaker, deep brain stimulation device, cochlear implant).
- •Any hearing impairment that prevents you from hearing the device's announcements.
- •Cognitive impairment detected on the basis of medical history and/or during a cognitive impairment telephone interview.
- •Expected or ongoing participation in another clinical trial or any research that may interfere with this study.
- •Known allergy to nickel, gold or a stainless-steel component.
- •Any health condition that may interfere with the study's evaluations.
- •A person unable to assemble the device and/or interpret the device's signals or who refuses to continue to participate in the study after passing the initial training phase with the device.
- •Person deemed unfit to participate in the study by the lead investigator for any other previously cited reason.
- •Adults who do not have the ability to provide valid informed consent (under legal protection)
结局指标
主要结局
Visual Function
时间窗: 12 months
Ultra Low Vision - Visual Function Questionnaire - 50 (ULV-VFQ-50), Aa validated self-assessment scale to measure functional vision in people with ultra low vision 50 items on a Likert scale, ranging from 1-4, higher scores indicated more difficult (lower visual ability)
次要结局
- Orientation and mobility tasks(12 months)
- Impact of Vision Impairment-Very Low Vision Quality of Life Scale(Baseline)
- Object recognition(12 months)
- Character identification(12 months)
- Impact of Vision Impairment-Very Low Vision Quality of Life Scale,(12 months)
- Adverse events related to device or study procedures(12 months)
研究者
研究点 (7)
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