NCT01334294已完成不适用
Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular AMD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF
研究概览
简要总结
ForeseeHome, an FDA-approved home device, was specifically designed for unsupervised Preferential-Hyperacuity-Perimeter (PHP) testing of Age Related Macular Degeneration (AMD) patients at home by characterizing central and paracentral metamorphopsia . The purpose of the current study is to evaluate if, in post-treatment patients, PHP parameters as measured with the ForeseeHome are in agreement with clinical decisions and retinal characteristics as measured with optical coherence tomography (OCT).
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received intravitreal antiangiogenic therapy for CNV in the study eye (SE), within 2-12 months prior to the study
- •Last diagnosis was, and current diagnosis is, no CNV activity in SE eye
- •Current plan in SE is clinical examination as standard care but at intervals of not more than 8 weeks.
- •Visual acuity of 20/80 or better in SE
- •Are capable and agree to sign a consent form and participate in the study
- •Age > 55 year of age
- •Are able to use a standard computer mouse correctly and without assistance
- •Have a working telephone landline at the main residence (cellular communication maybe available for the study, and then eliminate this requirement)
- •Clear view of the macular area on fundus photography
- •Are willing to give their name and contact information to Notal Vision, supplier of the device, so that the company can provide direct services if needed (e.g., assist in using the home device, report the frequency of usage, coordinate replacement of devices in case of a technical problems, etc.)
- •Agree to be examined by an ophthalmologist if SE shows symptoms of changes during the study
- •Have a US address and do not plan on traveling abroad during the study period
- •Fluent in English
- •Perform a reliable ForeseeHome test during the enrollment visit
排除标准
- •Evidence of macular disease other than AMD or glaucoma in SE
- •Presence of any significant media opacity that precludes a clear view of the macular area as identified in SE by biomicroscopy
- •Any non-macular related ocular surgery performed within 3 months prior to study entry in SE
- •Participant are not enrolled in another stuy that could affect the interval between clinical examinations, or the frequency of use of the ForeseeHome device
结局指标
主要结局
Assess the accuracy of the ForeseeHome to detect reactivation of CNV following successful treatment with Anti-VEGF
时间窗: 1 year
次要结局
- Evaluate the correlation between PHP measures and OCT measures(1 year)
研究者
研究点 (3)
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