The HOME Study: HOme Vision Monitoring in AREDS2 for Progression to Neovascular AMD Using the ForeseeHome Device - (HOme Monitoring of the Eye)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,520
- 试验地点
- 70
- 主要终点
- Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
研究概览
简要总结
The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 improves detection of progression to choroidal neovascularization (CNV) when compared with standard care.
详细描述
The overall objective of this two arm randomized clinical trial (RCT) is to determine if home monitoring using the comprehensive visual field and telemedicine solution based on the ForeseeHome device in AREDS2 (referred to as the ForeseeHome comprehensive solution) participants at high risk of progression to neovascular AMD improves detection of progression to choroidal neovascularization (CNV) when compared with standard care. The primary outcome of this study is presenting best corrected visual acuity (BCVA) at the time of CNV diagnosis. Secondary outcomes include time to confirmed CNV diagnosis, lesion size, lesion location (extrafoveal, juxtafoveal, or subfoveal), lesion type (occult without classic, predominantly classic or minimally classic), sensitivity and specificity, and BCVA following three consecutive months of treatment and twelve months after the initial start of CNV treatment with an intravitreal anti-VEGF agent using either ranibizumab or bevacizumab. Outcomes will be ascertained via the following specific aims:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ForeseeHome AMD Monitoring Device
Participants in the device monitoring arm will receive a packed device at home, with instructions to install and connect the device to a modem as well as instructions for daily use of the device in addition to standard care
干预措施: ForeseeHome AMD Monitoring Device (Diagnostic Test)
Standard care alone (control) arm
Standard care instruction per clinic routine for home vision monitoring to detect progression of AMD and routine eye exams
结局指标
主要结局
Primary Outcome: Change in Visual Acuity (LogMAR Letters) From Baseline to Detection of Choroidal Neovascularization
时间窗: 2 years
Mean change in BCVA (logMAR letters) from baseline to the time of confirmed progression to CNV in the ForeseeHome device monitoring group compared to the standard care group.
次要结局
- Secondary Outcome: Lesion Size (Total Lesion Area) at Time of Confirmed Progression to CNV(2 years)
- Secondary Outcome: Lesion Size (Fluid Area) at Time of Confirmed Progression to CNV(2 years)
- Secondary Outcome: Lesion Size (CNV Area) at Time of Confirmed Progression to CNV(2 years)
- Secondary Outcome: Patients Who Maintained 20/40 or Better Vision at Time of CNV Detection(2 years)