Brain-Computer Interface (BCI) and Evaluation of Visual and Task Performance in Subjects With Eye Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Visual Impairment Measured by Visual Functioning Test
研究概览
简要总结
The purpose of this research study is to better understand the impact of visual impairment caused by different eye diseases on the ability to perform daily activities and compare it to that in patients without eye diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Subjects must be between the ages of 18 and 90 years old;
- •Both males and females will be included.
- •Be able and willing to provide signed informed consent and follow study instructions
排除标准
- •Subjects will be excluded if they present with any systemic conditions that in the opinion of the Principal Investigator may prevent them from completing the tests.
研究组 & 干预措施
Glaucoma group
Patients with diagnosed glaucoma will be in the group for up to 5 years.
干预措施: Visual Performance tests (Diagnostic Test)
Glaucoma group
Patients with diagnosed glaucoma will be in the group for up to 5 years.
干预措施: Brain-computer interface (Device)
Suspicious of having glaucoma group
Patients with suspicious of having glaucoma will be in the group for up to 5 years.
干预措施: Visual Performance tests (Diagnostic Test)
Retinal degenerations group
Patients with other retinal degenerations excluding AMD will be in the group for up to 5 years.
干预措施: Visual Performance tests (Diagnostic Test)
Suspicious of having glaucoma group
Patients with suspicious of having glaucoma will be in the group for up to 5 years.
干预措施: Brain-computer interface (Device)
Non-glaucomatous optic neuropathies group
Patients with optic neuropathies that do not look glaucomatous-like will be in the group for up to 5 years.
干预措施: Visual Performance tests (Diagnostic Test)
Age-related macular degeneration (AMD) group
Patients with diagnosed age-related macular degeneration will be in the group for up to 5 years.
干预措施: Visual Performance tests (Diagnostic Test)
Other diseases of visual pathways group
Other diseases of the visual pathway not included in the previous groups will be in the group for up to 5 years.
干预措施: Visual Performance tests (Diagnostic Test)
Healthy control group
Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years.
干预措施: Visual Performance tests (Diagnostic Test)
Healthy control group
Patients labeled as healthy controls for not having any other eye diseases that would be included on the other groups will be in the group for up to 5 years.
干预措施: Brain-computer interface (Device)
结局指标
主要结局
Visual Impairment Measured by Visual Functioning Test
时间窗: 4.5 years
The study team will evaluate visual impairment through a composite score of visual functioning test, ranging from 0 to 100, with lower scores indicating worse visual impairment.
Number of Eyes Showing Progression
时间窗: 4.5 years
The number of eyes showing progression (expressed in percentage) will be compared between the home-based Brain-computer interface (BCI) testing and standard clinical testing (standard automated perimetry, SAP)
Time to Detect Progression Measured in Years
时间窗: 4.5 years
The time to detect progression (years) will be compared between the home-based Brain-computer interface testing and standard clinical testing (standard automated perimetry).
次要结局
- Standard Automated Perimetry Will be Assessed by the C-index(4.5 years)
- Patient-reported Quality of Life as Measured by the National Eye Institute (NEI) Visual Function Questionnaire (VFQ) 25(4.5 years)
研究者
Felipe Andrade Medeiros
Professor
University of Miami