Portable Retinal Imaging Device for Urgent Referrals and Remote Treatment

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摄像机DLP-Cam。未经治疗的DR已在全球服务不足的人群中达到流行水平。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的不平等。为了充分解决这个问题，DR筛查，其次是视力保护治疗，必须广泛提供给服务不足，在社区诊所设置。 为了应对日益增长的差距在眼睛护理，永旺成像提出了一种新的视网膜成像设备，DLP-Cam。通过结合现代照明，扫描和检测技术，永旺的DLP-凸轮将提供高对比度共焦的意见，视网膜没有扩张，并在预计生产成本大大低于竞争产品。DLP-Cam可从标准裂隙灯式下巴托和校准底座上轻松拆卸，以便在不同部位之间运输，并允许眼科护理专家进行手持视网膜成像。DLP-Cam将提供DR筛查中常用的无红色图像，以及近红外和彩色图像。这些高对比度图像，沿着荧光素血管造影术（在患者摄入荧光素染料之后）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。基于永旺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，永旺将建立5个DLP-Cam设备，并与加州大学伯克利分校和印第安纳州大学合作，将进行可行性测试， 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的工作人员在加利福尼亚州阿拉米达县的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提供县保险的眼科护理服务，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验证研究人口统计学，预计92%的受试者人群来自种族或少数民族，并且所有受试者都将被诊断为糖尿病 视网膜病变 为了评估口服FA的可能性，将使用DLP-Cam的FA成像模式对已经在印第安纳州大学接受FA联合视网膜疾病治疗的志愿者患者进行成像。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，永旺将对DLP-Cam及其低成本筛选系统进行现场测试，建立其在成本更高的方法方面的能力。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。 公共卫生相关性：项目叙述- RFA-EB-11-001第一阶段Aeon Imaging，LLC将开发一种低成本便携式视网膜摄像机DLP-Cam，为来自不同种族和民族背景的患者提供高对比度的视网膜图像，而无需瞳孔放大。DLP-Cam将用于糖尿病视网膜病变远程医疗筛查，并作为一种诊断设备，允许更多的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，便携式低成本视网膜摄像机将大大降低服务不足人群的眼科护理障碍。

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.