Low Cost and Portable Retinal Imager

描述（由申请人提供）：糖尿病视网膜病变（DR）是糖尿病的一种威胁视力的并发症，如果及早发现，可以更有效地治疗。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，该仪器将首次以高分辨率提取视网膜微血管的解剖学和生理学，而无需染料管理。LSC EYE预计成本不到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。我们已经开发了知识产权，通过两项创新实现这种设备：首先，使用激光散斑对比成像（LSCI）提取视网膜微血管生理学，其次，LSCI的便携式实现使用一种新型的成像传感器结合一个小型化的光学系统。该成像传感器是使用互补金属氧化物半导体（CMOS）技术定制设计和制造的，并且在灵敏度和噪声方面与传统使用的成像电荷耦合器件（CCD）相机不相上下。在第一阶段，我们将通过将一套新的图像增强算法纳入LSCI技术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。我们将生成第一个高分辨率的视网膜LSCI图像，能够分辨直径小于60微米的血管。在成功完成第一阶段的里程碑后，我们将开展第二阶段的工作，在此期间，我们将开发临床级便携式LSC EYE原型，申请研究器械豁免（IDE），并继续在少数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 公共卫生相关性：通过常规的视网膜增强成像，有可能早期诊断糖尿病视网膜病变。本课题的目的是研究激光对比度散斑成像技术的可行性，并将其应用于视网膜解剖学和生理学的高分辨率成像。我们将开发一个手持原型的视网膜成像仪器的规格，可能早期诊断糖尿病视网膜病变。

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.