Low Cost and Portable Retinal Imager

描述（由申请人提供）：糖尿病视网膜病变（DR）是一种威胁视力的糖尿病并发症，如果及早发现，可以更有效地控制。我们建议通过开发一种便携式视网膜成像仪器LSC EYE来实现这种早期诊断，该仪器将首次在不需要染料的情况下以高分辨率提取视网膜微血管的解剖和生理。LSC EYE预计花费不到2000美元，将使初级保健医生能够进行简单、快速和廉价的视网膜检查，从而及时诊断dr。我们通过两项创新开发了实现这种设备的核心知识产权：首先，利用激光散斑收缩成像（LSCI）提取视网膜微血管的生理特征；其次，利用一种新型的成像传感器结合小型光学系统实现LSCI的便携式实现。该成像传感器采用互补金属氧化物半导体（CMOS）技术定制设计和制造，在灵敏度和噪声方面与传统使用的成像电荷耦合器件（CCD）相机相当。在第一阶段，我们将通过将一套新的图像增强算法整合到LSCI技术中来证明实现便携式视网膜成像仪的可行性，并随后在临床前兔眼模型中验证LSC EYE的安全性和有效性。我们将生成第一张能够分辨直径小于60微米血管的视网膜高分辨率LSCI图像。在成功完成I期里程碑后，我们将开始我们的II期工作，在此期间，我们将开发临床级便携式LSC EYE原型，申请研究设备豁免（IDE），并继续在少量健康志愿者和晚期糖尿病患者中进行LSC EYE的初步临床研究。摘要

DESCRIPTION (provided by applicant): Diabetic Retinopathy (DR), a vision threatening complication of diabetes, can be managed more effectively if detected early. We propose to enable such early diagnosis by developing a portable retinal imaging instrument - LSC EYE - that will, for the first time, extract both the anatomy and physiology of retinal microvasculature t high resolution without the need for dye administration. The LSC EYE is expected to cost less than $2000 and will enable primary care physicians to administer simple, quick and inexpensive retinal exams leading to timely diagnosis of DR. We have developed intellectual property central to the realization of such a device through two innovations: firstly, the extraction of retinal microvessel physiology using laser speckle contract imaging (LSCI) and secondly, the portable implementation of LSCI using a novel imaging sensor in conjunction with a miniaturized optical system. The imaging sensor has been custom designed and fabricated using complementary metal oxide semiconductor (CMOS) technology and performs on par with conventionally used imaging charge coupled device (CCD)cameras with respect to both sensitivity and noise. During Phase I, we will demonstrate the feasibility of achieving a portable retinal imager by incorporating a suite of novel image-enhancing algorithms into the LSCI technique and subsequently validate the safety and efficacy of the LSC EYE in a preclinical rabbit eye model. We will generate the first high resolution LSCI images of the retina capable of resolving blood vessels with diameters less than 60¿m. Upon successful completion of Phase I milestones, we will embark on our Phase II efort during which we wil develop a clinical grade portable LSC EYE prototype, apply for investigational device exemption (IDE) and continue to undertake preliminary clinical investigation of the LSC EYE in small number of healthy volunteers and patients with advanced diabetes. ABSTRACT PUBLIC HEALTH RELEVANCE: There is a potential for early diagnosis of diabetic retinopathy through routine enhanced imaging of the retina. The goal of our project is to investigate the feasibility and develop laser contrast speckle imaging for high resolution imaging of retinal anatomy and physiology. We will develop a hand held prototype of a retinal imaging instrument with specifications, as might diagnose diabetic retinopathy early.