Longitudinal Observation and Assessment of the Suprachoroidal Retinal Prostheses
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Effectiveness of vision processing method in the 'real world' featured environment.
研究概览
简要总结
This is a longitudinal observational study with participants who have been implanted with the suprachoroidal retinal prosthesis.
详细描述
To observe and assess visual, orientation and mobility behavior with primary and adjunct vision processing (AVP) methods that may enhance the performance with the suprachoroidal retinal prosthesis (ScRP). To investigate the effectiveness of primary and AVP methods in the laboratory and real-world environments with the ScRP. Assess structural and functional ScRP stability with objective and subjective assessments. Record participant experiences and feedback with the ScRP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to provide signed informed consent;
- •Implanted with a suprachoroidal retinal prosthesis;
- •Be available for the study visits;
- •Willing to comply with study assessments;
- •In good general health and mobile.
排除标准
- •Medical condition that prohibits mobility;
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
结局指标
主要结局
Effectiveness of vision processing method in the 'real world' featured environment.
时间窗: 5 years.
Measure the effectiveness of the vision processing method via observational qualitative and quantitative data in participant 'real world' featured environment.
Effectiveness of vision processing method in the laboratory.
时间窗: 5 years.
Measure effectiveness of of the vision processing method via observational and quantitative data.
次要结局
- Participant interview.(5 years)
- Participant experience.(5 years)
- Device stability and functionality.(5 years.)