Low Cost and Portable Retinal Imager

低成本便携式视网膜成像仪

• 批准号: 8393304
• 负责人: Scott I Merz
• 金额: $ 22万
• 依托单位: MC3, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-30 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8393304
• 关键词: Adult; Affect; Algorithms; Anatomy; Blindness; Blood Vessels; Blood flow; Brain; Caliber; Clinic; Clinical; Clinical Trials; Complications of Diabetes Mellitus; Contracts; Custom; Data; Devices; Diabetes Mellitus; Diabetic Retinopathy; Diagnosis; Dyes; Ear; Early Diagnosis; Eye; Fluorescein Angiography; Fundus; Goals; Gold; Hand; Histologic; Image; Imaging Techniques; Imaging technology; Individual; Intellectual Property; Lasers; Legal patent; Lighting; Modeling; Monitor; Morphologic artifacts; Morphology; Motion; Mus; Noise; Ophthalmic examination and evaluation; Optics; Oryctolagus cuniculus; Patients; Phase; Physiology; Primary Care Physician; Procedures; Process; Pupil; Rattus; Resolution; Retina; Retinal; Safety; Scheme; Semiconductors; Skin; System; Techniques; Technology; Time; Translations; United States; Vision; base; charge coupled device camera; clinical efficacy; cost; design; diabetic; diabetic patient; healthy volunteer; image processing; improved; innovation; instrument; meetings; metal oxide; miniaturize; novel; novel strategies; optical imaging; pre-clinical; preclinical study; product development; prototype; research clinical testing; retinal damage; safety testing; sensor; verification and validation

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.

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，可以更有效地进行治疗。我们建议通过开发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： LSC EYE 首次无需高分辨率即可提取视网膜微脉管系统的解剖结构和生理学信息，无需使用染料，预计成本将低于 2000 美元。初级保健医生可以进行简单、快速且廉价的视网膜检查，从而及时诊断 DR。我们通过两项创新开发了实现此类设备的核心知识产权：首先，使用激光散斑契约成像提取视网膜微血管生理学（其次，使用新型成像传感器与小型化光学系统结合实现 LSCI 的便携式实施 该成像传感器采用互补金属氧化物半导体 (CMOS) 技术进行定制设计和制造，并且性能相当。在第一阶段，我们将展示通过将一套新颖的图像增强算法融入 LSCI 技术来实现便携式视网膜成像仪的可行性。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能够分辨直径小于 60¿ 的血管的高分辨率 LSCI 视网膜图像。 m. 成功完成第一阶段里程碑后，我们将开始第二阶段工作，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) 并继续对 LSC EYE 进行初步临床研究在少数健康志愿者和晚期糖尿病患者中。 公共健康相关性：通过视网膜的常规增强成像有可能早期诊断糖尿病视网膜病变。我们将研究可行性并开发用于视网膜解剖和生理学高分辨率成像的激光对比散斑成像。开发一种具有规格的手持式视网膜成像仪器原型，可以早期诊断糖尿病视网膜病变。