An Observational, Non-Significant Risk Study Of The Retinal Health Monitoring System (RHMS) - Visual Acuity Module - In Normal Patients And Patients With Neovascular Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Comparison of the reproducibility of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
研究概览
简要总结
Assess the performance and usability of the RHMS Visual Acuity Module.
详细描述
This 510(k)-enabling study is designed to assess the performance and usability of the RHMS Visual Acuity Module in normal patients and patients with neovascular AMD.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohort 1 - Normal subjects
- •Age ≥ 50 years
- •Corrected distance or near visual acuity (VA) of ≥ 20/25 Snellen equivalent, in the study eye
- •Able to perform self-testing with the Visual Acuity Module of the RHMS after training
- •Able and willing to give informed consent
- •Cohort 2 - Subjects with neovascular AMD
- •Age ≥ 50 years
- •History of neovascular age-related macular degeneration, in the study eye
- •Corrected distance or near VA of ≥ 20/200 Snellen equivalent, in the study eye
排除标准
- •Cohort 1 - Normal subjects
- •History of ophthalmic disease resulting in decrease in visual acuity per the Investigator, in the study eye
- •Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days
- •Cohort 2 - Subjects with neovascular AMD
- •History of geographic atrophy or macular atrophy within the central 3 mm of the macula, in the study eye
- •History of macular hole in the study eye
- •Use of any investigational drug in the past 30 days, or investigational, interventional device in the past 60 days
结局指标
主要结局
Comparison of the reproducibility of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
时间窗: 1 day
To evaluate the agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
Agreement of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
时间窗: 1 day
To evaluate the usability of the RHMS Visual Acuity Module
Comparison of the repeatability of CNVA measured by the RHMS Visual Acuity Module and the Reference Chart
时间窗: 1 day
To determine the precision (repeatability and reproducibility) of corrected near visual acuity (CNVA) measured by the RHMS Visual Acuity Module and an in-clinic, near logarithmic Sloan Letter chart (Reference Chart).
次要结局
未报告次要终点