ForeseeHome NRich Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD)
研究概览
简要总结
This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD) while monitored at home with the ForeseeHome Monitoring System (FSH) and during routine care with Spectral Domain Optical Coherence Tomography (SD-OCT) and to validate the predictive value of a non-NV-AMD FSH alerts.
详细描述
The participants include those actively monitoring on the FSH program which requires diagnosis of intermediate AMD and visual acuity of 20/60 or better that establish a valid baseline in at least one eye. The process of establishing a baseline is completed several weeks after setup of the device at home and initiation of testing. The aim of the registry is to collect data up to 20,000 patients on the ForeseeHome program for at least one year. The data will be collected for approximately a period of 5 years.
The registry will include clinics that provide direct care to the patients on the ForeseeHome device, and Notal Vision Monitoring Center. The registry aims to collect data from about 200 referring physicians.
The registry will include structural and functional data for the patients active on the ForeseeHome device. The details of data points to be collected are mentioned below.
Data from participating sites will be collected in a de-identified manner and collected in the registry. Patients will be assigned a patient ID and will be collected in a sequential manner from each site. No data shall be acquired outside standard of care. Not all data points for each patient are expected to be present. The following data points shall be shared in the registry:
From Notal Vision Monitoring Center
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participants include those actively monitoring on the FSH program which requires diagnosis of intermediate AMD and visual acuity of 20/60 or better that establish a valid baseline in at least one eye.
排除标准
- •Patients that are unable to establish a baseline
结局指标
主要结局
This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD)
时间窗: 5 years
This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD) while monitored at home with the ForeseeHome Monitoring System (FSH) and during routine care with SD-OCT and to validate the predictive value of a non-NV-AMD FSH alerts.
次要结局
未报告次要终点