Device 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
- 31
- 试验地点
- 1
- 主要终点
- System usability scale
研究概览
简要总结
This study involves user acceptability and feedback of KalEYEdoscope, a digital, handheld device utilizing shape-discrimination hyperacuity to distinguish the severity of age-related macular degeneration (AMD).
详细描述
This is a patient-experience study being conducted at the Kellogg Eye Center in Ann Arbor in the outpatient setting. Patients who agree to enroll in the study will test the device and provide user feedback via a questionnaire as well as complete questionnaires about their visual function. The preliminary study looks at the usability of using this device for monitoring of age-related macular degeneration, obtaining user feedback to enhance the design. In the future, developing such a device for home monitoring of macular degeneration may increase access to timely treatment to prevent vision loss.
To gather user feedback on a digital, non-invasive, handheld device in the outpatient AMD patient population, with the goal of developing a user-friendly, portable device to monitor AMD progression, this study assesses the usability, comfort, duration, ergonomics, and ease of use of the device among AMD patients in a single session.
Data collected during the test may include but is not limited to the length of the test, boot time, screen transition time. The participants will then fill out the Visual Function Questionnaire-25, the System Usability Scale (SUS), and may include targeted questions designed by the study team to evaluate the participant experience with the device and visual function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient aged 18 years or older with age-related macular degeneration who is seen at the Kellogg Eye Center.
排除标准
- •pregnant women, prisoners, severe cognitive impairment, and diagnoses (mental or neuromuscular disorders) which could preclude independent use of the device.
结局指标
主要结局
System usability scale
时间窗: immediate during a single office visit - generally 5- 15 minutes
Obtain user feedback via a questionnaire and evaluate the usability of using this device.
次要结局
- Participant Experience Survey(immediate during a single office visit - generally 5- 15 minutes)
- National Eye Institute Visual function questionnaire (NEI VFQ 25)(immediate during a single office visit - generally 5- 15 minutes)
研究者
Yannis Paulus
Associate Professor, Department of Ophthalmology and Visual Sciences
University of Michigan
