Department of Radiology, Weill Cornell Medicine, New York, New York, USA.
Singapore Eye Research Institute, Singapore National Eye Centre, Duke-NUS, Singapore City, Singapore.
Ophthalmic Physiol Opt. 2023 May;43(3):544-557. doi: 10.1111/opo.13122. Epub 2023 Mar 21.
To develop a point-of-care (POC) device using high-frequency ultrasound (US) for evaluating microstructural changes in the anterior sclera associated with myopia.
The proposed POC device must satisfy four primary requirements for effective clinical use: the measurement component is handheld; the software must be simple and provide real-time feedback; patient safety and health data security requirements set forth by relevant governing bodies must be satisfied and the measurement data must have sufficient signal-to-noise ratio (SNR) and repeatability. Radiofrequency (RF) echo data acquired by the POC device will be processed using our quantitative US methods to characterise tissue microstructure and biomechanical properties.
All stated requirements have been met in the developed POC device. The high-frequency transducer is housed in a custom, 3D-printed, pen-like holder that allows for easy measurements of the anterior sclera. Custom software provides a simple interface for data acquisition, real-time data display and secure data storage. Exposimetry measurements of the US pressure field indicate device compliance with United States Food and Drug Administration limits for ophthalmic US. In vivo measurements on a volunteer suggest the RF data SNR and acquisition consistency are suitable for quantitative analysis.
A fully functioning POC device using high-frequency US has been created for evaluating the microstructure of the anterior sclera. Planned studies using the POC device to scan the eyes of myopia patients will help clarify how the anterior sclera microstructure may be affected by myopia. If effective, this portable, inexpensive and user-friendly system could be an important part of routine eye examinations.
开发一种使用高频超声(US)的即时检测(POC)设备,用于评估与近视相关的前巩膜微观结构变化。
拟议的 POC 设备必须满足有效临床使用的四项主要要求:测量组件为手持式;软件必须简单,并提供实时反馈;必须满足相关管理机构规定的患者安全和健康数据安全要求,并且测量数据必须具有足够的信噪比(SNR)和可重复性。POC 设备采集的射频(RF)回波数据将使用我们的定量 US 方法进行处理,以描述组织微观结构和生物力学特性。
在开发的 POC 设备中满足了所有规定的要求。高频换能器被安装在定制的、3D 打印的、笔状的支架中,允许轻松测量前巩膜。定制软件提供了一个简单的界面,用于数据采集、实时数据显示和安全数据存储。US 压力场的曝光测量表明,该设备符合美国食品和药物管理局对眼科 US 的限制。对志愿者进行的体内测量表明,RF 数据的 SNR 和采集一致性适合定量分析。
已经创建了一种使用高频 US 的全功能 POC 设备,用于评估前巩膜的微观结构。使用 POC 设备扫描近视患者眼睛的计划研究将有助于阐明前巩膜微观结构如何受到近视的影响。如果有效,这种便携式、价格低廉且易于使用的系统可能成为常规眼部检查的重要组成部分。