Laser Speckle Imaging Chip for Telehealth Applications

用于远程医疗应用的激光散斑成像芯片

• 批准号: 9466379
• 负责人: Abhishek Rege
• 金额: $ 74.05万
• 依托单位: VASOPTIC MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9466379
• 关键词: Address; Affect; Algorithms; Alzheimer' s Disease; Angiography; Animal Model; Arteries; Background Diabetic Retinopathy; Biological Markers; Blood Vessels; Blood flow; Caliber; Cardiovascular system; Cause of Death; Clinic; Clinical; Clinical Research; Clinical Trials; Collection; Complement; Computer Analysis; Computer software; Control Groups; Custom; Data; Dementia; Development; Diabetes Mellitus; Diabetic Retinopathy; Diagnosis; Diagnostic; Diagnostic Sensitivity; Diagnostic tests; Diagnostics Research; Disadvantaged; Disease; Disease Management; Dyes; Elderly; Environment; Equilibrium; Exudate; FDA approved; Face; Feasibility Studies; Functional disorder; Fundus; Goals; Gold; Health; Hemorrhage; Hypertension; Image; Imaging Device; Imaging technology; Individual; Investigation; Laser Speckle Imaging; Learning; Light; Literature; Manuals; Measurement; Measures; Methods; Microaneurysm; Monitor; Morphology; Multi-Institutional Clinical Trial; Neurologic; Noise; Ophthalmology; Ophthalmoscopes; Outcome; Patients; Performance; Phase; Physiological; Physiology; Positioning Attribute; Preparation; Primary Health Care; Public Health; Quality of life; Recruitment Activity; Regional Perfusion; Reporting; Reproducibility; Research; Resolution; Retina; Retinal; Retinal Diseases; Risk; Rodent Model; Safety; Sensitivity and Specificity; Severities; Signal Transduction; Specialist; Specificity; Standardization; Stroke; Symptoms; System; Technology; Testing; Time; Tissues; Toxic effect; Training; United States; Validation; Veins; Visual impairment; base; beneficiary; cardiovascular health; clinical diagnostics; community setting; compliance behavior; cost; density; design; digital; disease classification; disease diagnosis; disorder control; experience; experimental study; human subject; improved; innovation; instrument; mild cognitive impairment; novel; novel marker; phase 1 study; point of care; portability; primary care setting; programs; prototype; retina blood vessel structure; screening; spatiotemporal; success; telehealth; tool; usability

ABSTRACT The availability of improved diagnostic tools in the primary care environment capable of diagnosing diseases in their earliest stages could significantly improve disease management. Primary beneficiaries would be the elderly, who are at increased risk for a number of progressively debilitating diseases, but who may face practical cost and convenience hurdles in routinely presenting to specialists for examination. Retinal imaging is increasingly being recognized as a means to monitor not just ophthalmic health, but also as a surrogate indicator of neurological and cardiovascular health. And therefore, there is increasing support for its integration into primary care practice via telehealth approaches. However, current retinal imaging products that meet the cost, size, and use case requirements of the primary care environment have significant limitations in their abilities such as their inadequacy to measure blood flow or other dynamic changes in physiology. To address this shortcoming of current technology and make a clinical impact, Vasoptic has proposed to develop and commercialize a low-cost, portable, noninvasive retinal imaging instrument (the XyCAM) that can complement fundus photographs with retinal blood flow information obtained at high spatio-temporal resolution without the introduction of any dyes. During Phase I studies, we designed and developed a custom image sensing chip with high signal to noise ratio, as needed for the low-light retinal imaging application, and developed a handheld prototype with a robust software suite for image acquisition and analysis. Upon confirming safety against light toxicity, we characterized performance of the XyCAM prototype by conducting proof-of-concept experiments in animal models and proof-of-feasibility studies in human subjects. Our investigation has indicated that the XyCAM prototype can image retinal blood flow with a high spatio- temporal resolution and with high reproducibility. Based on this success and our learnings, we propose a Phase II effort which will include (a) development and validation of robust mechanisms to automatically and objectively assess the vascular status in the retina; and (b) demonstration of preliminary feasibility that the XyCAM can discriminate between normal and diseased retinas through point-of-care assessment of retinal blood flow and associated morphological and physiological metrics. Our Phase II application focuses on two disease conditions that affect the elderly and severely impact their quality of life – Alzheimer’s disease, which is also the sixth leading cause of death in the United States and diabetic retinopathy, which causes as many as 65,000 individuals to experience serious visual impairment every year. While the former could also benefit from research carried out in primary care environments leading to the development of retinal blood flow as a robust biomarker for diagnostics, the latter could benefit from increased patient compliance and early diagnostics as is possible through telehealth methods. If we are successful, this study will enable a 510(k) submission to the US FDA seeking approval to market the validated XyCAM as a general purpose retinal imager and provide us the necessary early feasibility data that justifies multi-center clinical trials to investigate the sensitivity and specificity for various disease diagnostics.

抽象的 在初级保健环境中的改进诊断工具的可用性能够在其中诊断疾病 最早的阶段可以显着改善疾病管理。主要受益人将是老年人 增加了许多逐渐使人衰弱的疾病的风险，但谁可能面临实际的成本和便利性 常规向专家进行检查的障碍。视网膜成像越来越被视为一种手段 不仅监测眼科健康，还可以作为神经系统和心血管健康的替代指标。和 因此，通过远程医疗方法将其整合到初级保健实践中的支持越来越多。然而， 当前满足初级保健环境成本，大小和用例要求的当前视网膜成像产品 其能力有重大限制，例如测量血流或其他动态变化的不足 生理。 为了解决当前技术的这一缺点并产生临床影响，Vasoptic提出了开发和 商业化可以补充眼底的低成本，便携式，非侵入性视网膜成像仪器（XYCAM） 带有剩余血流信息的照片以高时空分辨率获得 任何染料。在I期研究期间，我们设计并开发了一种具有高信号与噪声比的自定义图像传感芯片， 根据需要进行较低的常规成像应用，并开发了具有健壮软件套件的手持原型 用于图像获取和分析。确认对轻毒性的安全性，我们表征了 Xycam原型通过在动物模型中进行概念验证实验和人类的可行性研究 主题。我们的研究表明，Xycam原型可以以高空间形象对视网膜血流进行图像 临时分辨率和高可重现性。基于这一成功和我们的学习，我们提出了第二阶段的努力 其中包括（a）开发和验证可靠机制，以自动和客观地评估 视网膜中的血管状态； （b）Xycam可以区分的初步可行性的演示 通过评估残留血流和相关形态和相关形态和 第二阶段的应用侧重于两种疾病，这些疾病的疾病会影响更老 影响他们的生活质量 - 阿尔茨海默氏病，这也是美国第六大死亡原因， 糖尿病性视网膜病，导致多达65,000名患者每年都会遭受严重的视觉障碍。 尽管前者也可能受益于在初级保健环境中进行的研究，从而导致发展 视网膜血流是用于诊断诊断的强大生物标志物，后者可能会受益于患者的依从性和 尽可能通过远程医疗方法进行早期诊断。 如果我们成功，这项研究将使美国FDA提交510（k），以寻求批准以销售已验证的 Xycam作为通用残差成像仪，并为我们提供必要的早期可行性数据，以证明多中心合理 临床试验，以研究各种疾病诊断的敏感性和特异性。