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.

摘要 在初级保健环境中提供改进的诊断工具， 早期阶段可以显著改善疾病管理。主要受益者将是老年人， 增加了患一些逐渐衰弱的疾病的风险，但可能面临实际费用和便利 常规提交给专家进行检查的障碍。视网膜成像越来越被认为是一种手段， 不仅监测眼科健康，而且作为神经和心血管健康的替代指标。和 因此，越来越多的人支持通过远程保健方法将其纳入初级保健实践。然而，在这方面， 满足初级护理环境的成本、尺寸和用例要求的当前视网膜成像产品 在他们的能力上有很大的局限性，例如他们不足以测量血流或其他动态变化， physiology. 为了解决当前技术的这一缺点并产生临床影响，Vasoptic提出开发和 将一种低成本、便携式、非侵入性的视网膜成像仪器（XyCAM）商业化， 具有以高时空分辨率获得的视网膜血流信息的照片， 任何染料。在第一阶段的研究中，我们设计和开发了一个定制的图像传感芯片，具有高信噪比， 并开发了一个具有强大软件套件的手持原型 用于图像采集和分析。在确认针对光毒性的安全性后，我们表征了所述组合物的性能。 通过在动物模型中进行概念验证实验和在人体中进行可行性验证研究， 科目我们的研究表明，XyCAM原型可以成像视网膜血流与高空间比， 时间分辨率和高再现性。基于这一成功和我们的学习，我们提出了第二阶段的努力， 其中将包括（a）建立和验证强有力的机制， 视网膜中的血管状态;和（B）初步证明XyCAM可以区分 通过对视网膜血流的即时评估以及相关的形态学和 生理指标我们的第二阶段申请集中在两种疾病的条件，影响老年人和严重 影响他们的生活质量-阿尔茨海默病，这也是美国第六大死亡原因， 糖尿病视网膜病变，每年导致多达65，000人经历严重的视力障碍。 虽然前者也可以受益于在初级保健环境中进行的研究， 视网膜血流作为诊断的强大生物标志物，后者可以受益于增加患者的依从性， 通过远程保健方法尽可能进行早期诊断。 如果我们成功，本研究将向美国FDA提交510（k）申请，寻求批准上市经验证的 XyCAM作为一种通用视网膜成像仪，为我们提供了必要的早期可行性数据，证明了多中心 临床试验，以研究各种疾病诊断的灵敏度和特异性。