Foresee Home for Monitoring Age Related Macular Degeneration (AMD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To investigate the FORESEE HOME ability to diagnose AMD in different stages
研究概览
简要总结
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.
详细描述
The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.
The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.
The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable and willing to sign a consent form and participate in the study
- •Subjects diagnosed as CNV under treatment or Intermediate AMD in at least one eye
- •Did not perform more then 10 anti- VEGF injections
- •Age >50 years
- •VA with habitual correction >6/45 in the study eye
- •Computer users
排除标准
- •Evidence of macular disease other than AMD or glaucoma in the study eye
- •Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
- •Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
结局指标
主要结局
To investigate the FORESEE HOME ability to diagnose AMD in different stages
时间窗: 1 year
次要结局
- To investigate the correlation between visual fields (VF) defects map generated by the FORESEE HOME and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).(1 year)