Portable Retinal Imaging Device for Urgent Referrals and Remote Treatment

用于紧急转诊和远程治疗的便携式视网膜成像设备

• 批准号: 8265541
• 负责人: Matthew S Muller
• 金额: $ 19.99万
• 依托单位: AEON IMAGING, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-04-01 至 2014-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8265541
• 关键词: Address; Adult; Age; American; American Indian and Alaska Native; Appointment; Area; Awareness; Blindness; Blood Vessels; California; Caring; Centers for Disease Control and Prevention (U.S.); Chin; Clinic; Collaborations; Color; Communication; Communities; Commuting; Complications of Diabetes Mellitus; County; Data; Detection; Devices; Diabetes Mellitus; Diabetic Retinopathy; Diagnosis; Disease; Dyes; Early treatment; Economics; Edema; Education; Electronics; Epidemic; Equipment; Evaluation; Extravasation; Eye; Eye diseases; Feasibility Studies; Feedback; Fluorescein; Fluorescein Angiography; Foundations; Fundus; Goals; Health Insurance; Hispanics; Human Resources; Image; Imaging Device; Indiana; Individual; Ingestion; Injection of therapeutic agent; Intellectual Property; Internet; Knowledge; Lasers; Light; Lighting; Location; Low income; Medical center; Minority; Modeling; Monitor; National Eye Institute; Not Hispanic or Latino; Ophthalmology; Optometry; Oral; Patient Care; Patients; Pattern; Phase; Population; Population Group; Positioning Attribute; Production; Recommendation; Research Infrastructure; Rest; Retina; Retinal; Retinal Diseases; Risk; Scanning; Schools; Screening procedure; Secure; Series; Services; Site; Small Business Innovation Research Grant; Specialist; Surveys; System; Technology; Telemedicine; Testing; Therapeutic; Time; Travel; Underserved Population; Universities; Vision; Waiting Lists; Wellness Center; Work; base; checkup examination; cost; cost effective; demographics; design; diabetic; digital; disorder prevention; ethnic minority population; eye center; flexibility; health disparity; macular edema; medical specialties; novel; operation; programs; response; sensor; treatment site; validation studies; volunteer; willingness

DESCRIPTION (provided by applicant): The overall goal of the proposed SBIR program is to implement and evaluate a low cost portable retinal camera, the DLP-Cam, in a community-based system for diabetic retinopathy (DR) screening and treatment. Untreated DR has reached epidemic levels in underserved populations worldwide. The cost of care, patient awareness and education, and the inadequate availability of community-based disease treatment all contribute to the current disparities in eye care. To fully address this issue, DR screening, followed by vision-saving treatment, must be widely available to the underserved, within the community clinic setting. In response to the ever-growing disparities in eye care, Aeon Imaging proposes a novel retinal imaging device, the DLP-Cam. By combining modern illumination, scanning, and detection technologies, Aeon's DLP- Cam will provide high contrast confocal views of the retina with no dilation, and at a projected production cost considerably below competing products. The DLP-Cam will be easily detachable from a standard slit-lamp style chin rest and alignment base to transport between sites and to permit handheld retinal imaging by eye care specialists. The DLP-Cam will provide red-free images commonly used in DR screening, as well as near IR and color images. These high contrast images, along with fluorescein angiography (after a patient's ingestion of fluorescein dye) will detect treatable areas of vascular leakage and macular edema to support on- site treatment. Building on Aeon's existing Laser Scanning Digital Camera (LSDC) telemedicine platform, data will be automatically encrypted and uploaded to a secure server for review and referral recommendations. In Phase I, Aeon will build 5 DLP-Cam devices and, in collaboration with UC Berkeley and Indiana University, will perform feasibility testing for DR screening and fluorescein angiography (FA). The DR screening will be conducted by UC Berkeley personnel at the Eastmont Wellness Center community clinic in Alameda County, CA. This community clinic provides county-insured eye care services to the underserved and is already conducting DR screening within the EyePACS telemedicine network, administered by UC Berkeley. Based on ongoing LSDC validation study demographics, 92% of the subject population is expected to be from a racial or ethnic minority, and all will have diagnosed diabetic retinopathy. To assess the potential for oral FA, volunteer patients already undergoing FA in conjunction with retinal disease treatment at Indiana University will be imaged using the DLP-Cam's FA imaging mode. By observing vascular leakage and edema with a portable device, Aeon aims to encourage retinal specialists to deliver treatment with portable lasers or intravitrea injections in the community/multi-specialty clinic setting. At the conclusion of Phase I, Aeon wil have field-tested the DLP-Cam and its low cost screening system, establishing its capability with respect to costlier approaches. If successful, Aeon will be prepared to expand DR screening operations and encourage community clinic disease treatment to help reduce health disparities. PUBLIC HEALTH RELEVANCE: Project Narrative - RFA-EB-11-001 Phase I Aeon Imaging, LLC, will develop a low cost and portable retinal camera, the DLP-Cam, to provide high contrast retinal images without pupil dilatation in patients from diverse racial and ethnic backgrounds. The DLP-Cam will be tested for diabetic retinopathy telemedicine screening, and as a diagnostic device to permit more retinal specialists to deliver a greater range of eye disease treatment in community clinics. If successful, a portable and low cost retinal camera will significantly lower the barriers to eye care among the underserved.

描述（由申请人提供）：拟议 SBIR 计划的总体目标是在基于社区的糖尿病视网膜病变 (DR) 筛查和治疗系统中实施和评估低成本便携式视网膜相机 DLP-Cam。未经治疗的 DR 在全世界服务不足的人群中已达到流行水平。护理成本、患者意识和教育以及社区疾病治疗的不足都导致了目前眼科护理方面的差异。为了充分解决这个问题，必须在社区诊所环境中向服务不足的人群广泛提供 DR 筛查以及随后的视力挽救治疗。 为了应对眼保健领域日益扩大的差异，Aeon Imaging 提出了一种新型视网膜成像设备：DLP-Cam。通过结合现代照明、扫描和检测技术，Aeon 的 DLP-Cam 将提供无扩张的视网膜高对比度共焦视图，并且预计生产成本大大低于竞争产品。 DLP-Cam 可轻松从标准裂隙灯式下巴托和对准底座上拆卸下来，以便在不同地点之间运输，并允许眼科护理专家进行手持式视网膜成像。 DLP-Cam 将提供 DR 筛选中常用的无红图像，以及近红外和彩色图像。这些高对比度图像以及荧光素血管造影（患者摄入荧光素染料后）将检测血管渗漏和黄斑水肿的可治疗区域，以支持现场治疗。基于 Aeon 现有的激光扫描数码相机 (LSDC) 远程医疗平台，数据将自动加密并上传到安全服务器以供审查和转诊建议。 在第一阶段，Aeon 将建造 5 台 DLP-Cam 设备，并与加州大学伯克利分校和印第安纳大学合作，进行可行性测试 DR 筛查和荧光素血管造影 (FA)。 DR 筛查将由加州大学伯克利分校人员在加利福尼亚州阿拉米达县伊斯特蒙特健康中心社区诊所进行。该社区诊所为服务不足的人群提供县保险眼保健服务，并已在加州大学伯克利分校管理的 EyePACS 远程医疗网络内进行 DR 筛查。根据正在进行的 LSDC 验证研究人口统计数据，预计 92% 的受试者来自少数种族或族裔，并且所有人都被诊断为糖尿病 视网膜病变。 为了评估口服 FA 的潜力，已在印第安纳大学接受 FA 与视网膜疾病治疗的志愿者患者将使用 DLP-Cam 的 FA 成像模式进行成像。通过使用便携式设备观察血管渗漏和水肿，Aeon 旨在鼓励视网膜专家在社区/多专科诊所环境中使用便携式激光或玻璃体内注射进行治疗。 在第一阶段结束时，Aeon 将现场测试 DLP-Cam 及其低成本筛选系统，建立其针对成本较高的方法的能力。如果成功，永旺将准备扩大 DR 筛查业务并鼓励社区诊所疾病治疗，以帮助减少健康差距。 公共健康相关性：项目叙述 - RFA-EB-11-001 第一阶段 Aeon Imaging, LLC 将开发一款低成本便携式视网膜相机 DLP-Cam，为不同种族的患者提供高对比度视网膜图像，而无需瞳孔扩张和种族背景。 DLP-Cam 将针对糖尿病视网膜病变远程医疗筛查进行测试，并作为一种诊断设备，让更多视网膜专家在社区诊所提供更广泛的眼科疾病治疗。如果成功，便携式、低成本的视网膜相机将显着降低服务不足的人群获得眼部护理的障碍。