跳至主要内容
临床试验/NCT06178978
NCT06178978已完成不适用

Device for Monitoring Age-related Macular Degeneration (AMD)

University of Michigan1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2022年3月10日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yannis Paulus

Associate Professor, Department of Ophthalmology and Visual Sciences

University of Michigan

研究点 (1)

Loading locations...

相似试验