Novel in-vivo ultrasound-based point-of-care instrument to assess myopia level and progression

用于评估近视程度和进展的新型体内超声护理仪器

• 批准号: 9903615
• 负责人: JONATHAN MAMOU
• 金额: $ 27.36万
• 依托单位: RIVERSIDE RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2022-04-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9903615
• 关键词: Adoption; Animal Model; Anterior; Biometry; Blindness; Caring; Clinical; Clinical Research; Computer software; Computers; Data; Degenerative Myopia; Development; Device or Instrument Development; Devices; Disease; Disease Progression; Elements; Evaluation; Eye; Eye Banks; Feedback; Frequencies; Gel; Human; Knowledge; Length; Measurement; Measures; Mechanics; Methods; Myopia; Ophthalmologist; Ophthalmology; Output; Patients; Physiologic pulse; Play; Point-of-Care Systems; Prevalence; Process; Property; Refractive Errors; Regulation; Research; Research Institute; Role; Safety; Sclera; Severities; Severity of illness; Signal Transduction; Singapore; Structure; System; Testing; Time; Transducers; Ultrasonography; Validation; Vision; arm; base; clinical research site; cost; data acquisition; design; elastography; eye center; graphical user interface; in vivo; innovation; instrument; mechanical properties; novel; point of care; portability; prospective; prototype; quantitative ultrasound; radio frequency; soft tissue; statistics; time use; touchscreen

This proposed project is intended to develop a novel, low-cost, compact, point-of-care (POC) ultrasound system to assess myopia severity and progression in vivo. Myopia prevalence is increasing worldwide and pathologic myopia is one of the leading causes of blindness. Myopia originates from structural and mechanical changes in the sclera that precede vision-threatening ocular changes. Currently, no method exists to assess myopia progression and severity quantitatively in vivo, and this project seeks to fill this gap. The POC instrument to be developed will consist of a single-element, spherically focused transducer operating at an 80-MHz center frequency mounted in a handheld probe and connected to a computer equipped with dedicated software, hardware, and a touch screen for ease of use using a graphical user interface. The POC instrument will collect RF, A-line data at a high pulse-repetition frequency while in direct contact with the anterior sclera. The RF data will be processed using QUS methods to derive so- called QUS estimates associated with the elastic and microstructural properties of the sclera. The QUS estimates will be based on the backscatter coefficient and envelope statistics as well as on highly- innovative passive elastography. The POC instrument will be portable, low-cost, real-time, and nonionizing. It will be very similar to pachymeters currently used by ophthalmologists for biometric measurements, which will facilitate its adoption by clinicians. In Year 2, the POC instrument will be deployed at our collaborating clinical site, the Singapore Eye Research Institute, to acquire and process data from 100 patients during a prospective clinical study aimed at assessing the value of the POC instrument for evaluating high-myopia patients. Specifically, the clinical study will test the ability of the system to predict myopia severity and progression. If successful, these studies will not only advance myopia knowledge significantly, but, equally important, the proposed POC instrument will revolutionize care for myopia patients by providing a low-cost, easy-to-use, and safe means to assess disease severity and progression.

该拟议项目旨在开发一种新颖、低成本、紧凑的床旁 (POC) 超声检查 体内评估近视严重程度和进展的系统。近视患病率在全球范围内不断增加 病理性近视是导致失明的主要原因之一。近视源于结构性和 在威胁视力的眼部变化之前出现的巩膜机械变化。目前还没有方法 存在于体内定量评估近视进展和严重程度，该项目旨在填补这一空白 差距。待开发的 POC 仪器将由单元件、球形聚焦传感器组成 以 80 MHz 中心频率运行，安装在手持式探头中并连接到计算机 配备专用软件、硬件和触摸屏，方便图形用户使用 界面。 POC 仪器将以高脉冲重复频率收集 RF、A 线数据，同时 直接接触前巩膜。 RF 数据将使用 QUS 方法进行处理，以得出这样的结果： 称为 QUS 估计，与巩膜的弹性和微观结构特性相关。昆士兰大学 估计将基于后向散射系数和包络统计以及高度 创新的被动弹性成像。 POC 仪器将是便携式的、低成本的、实时的、 非电离化。它将与眼科医生目前用于生物识别的测厚仪非常相似 测量，这将有助于临床医生采用它。在第 2 年，POC 工具将是 部署在我们的合作临床基地新加坡眼科研究所，以获取和处理 旨在评估 POC 价值的前瞻性临床研究期间收集的 100 名患者的数据 用于评估高度近视患者的仪器。具体来说，临床研究将测试患者的能力 预测近视严重程度和进展的系统。如果成功的话，这些研究不仅将推进 近视知识意义重大，但同样重要的是，拟议的 POC 工具将彻底改变 通过提供低成本、易于使用且安全的方法来评估疾病严重程度来护理近视患者 和进展。