Yim Angela C, Azzouz Lyna, Paulus Yannis M
Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, MI 48105, USA.
Department of Ophthalmology, Stanford University, Stanford, CA 94305, USA.
Diagnostics (Basel). 2025 May 28;15(11):1353. doi: 10.3390/diagnostics15111353.
A novel, handheld, standalone device using shape discrimination hyperacuity has been developed to remotely monitor age-related macular degeneration (AMD). We clinically validated the device in an outpatient dry AMD population to evaluate its usability and comfort. A cross-sectional study was conducted with subjects aged 50 years or older with dry AMD at the University of Michigan Kellogg Eye Center outpatient clinic after approval from the UM IRB (HUM00187177). Subjects used the device and then completed a device survey and System Usability Scale (SUS). Thirty-one subjects completed the study, and one subject withdrew post-study completion (mean age 77 years, STD 8 years). The mean testing time was 126 s (STD 56 s), and the median was 116 s. Most patients reported that the use of the device occurred for an acceptable duration (97%), was easy (97%), and was comfortable (90%). The mean SUS score was 77.7 (STD 11.9). A handheld, standalone device can provide a rapid, easy, and comfortable testing solution for patients with dry AMD. The usability of the device supports further clinical trials to demonstrate the device's ability to reliably detect the progression of AMD.
一种采用形状辨别超敏锐度的新型手持式独立设备已被开发出来,用于远程监测年龄相关性黄斑变性(AMD)。我们在门诊干性AMD患者群体中对该设备进行了临床验证,以评估其可用性和舒适度。在获得密歇根大学机构审查委员会(UM IRB,批准号HUM00187177)批准后,在密歇根大学凯洛格眼科中心门诊对年龄在50岁及以上的干性AMD患者进行了一项横断面研究。受试者使用该设备,然后完成一份设备调查问卷和系统可用性量表(SUS)。31名受试者完成了研究,1名受试者在研究结束后退出(平均年龄77岁,标准差8岁)。平均测试时间为126秒(标准差56秒),中位数为116秒。大多数患者报告称,使用该设备的时长可以接受(97%),操作简便(97%),且感觉舒适(90%)。SUS平均得分为77.7(标准差11.9)。一种手持式独立设备可以为干性AMD患者提供快速、简便且舒适的检测解决方案。该设备的可用性支持进一步开展临床试验,以证明该设备可靠检测AMD进展的能力。