Portable Retinal Imaging Device for Urgent Referrals and Remote Treatment

描述(申请人提供)：建议的SBIR计划的总体目标是在社区糖尿病视网膜病变(DR)筛查和治疗系统中实施和评估一种低成本便携式视网膜摄像头DLP-Cam。未经治疗的DR已在世界各地服务不足的人群中达到流行水平。护理费用、患者意识和教育，以及社区疾病治疗的不足，都是造成眼科护理目前差距的原因。为了充分解决这一问题，必须在社区诊所环境中向服务不足的人广泛提供DR筛查，然后是挽救视力的治疗。为了应对日益扩大的眼睛护理差距，永旺成像提出了一种新型的视网膜成像设备，DLP-Cam。通过结合现代照明、扫描和检测技术，永旺的DLP-Cam将提供高对比度的视网膜共聚焦视图，而不会扩张，预计生产成本将大大低于竞争产品。DLP-Cam将很容易从标准的裂隙灯样式的下巴支架和对准底座上拆卸下来，以便在不同位置之间进行运输，并允许眼睛护理专家进行手持视网膜成像。DLP-Cam将提供DR筛查中常用的无红图像，以及近红外和彩色图像。这些高对比度图像，连同荧光素血管造影(在患者摄入荧光素染料后)将检测到可治疗的血管渗漏和黄斑水肿区域，以支持现场治疗。在永旺现有的激光扫描数码相机(LSDC)远程医疗平台的基础上，数据将自动加密并上传到安全服务器，以供审查和推荐。在第一阶段，永旺将建造5个DLP-Cam设备，并将与加州大学伯克利分校和印第安纳大学合作，为 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。这家社区诊所为服务不足的人提供县级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验证研究的人口统计学数据，92%的受试者预计来自种族或少数民族，所有人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，已经在印第安纳大学接受FA和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，永旺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，以确定其针对成本更高的方法的能力。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，以帮助缩小健康差距。 公共卫生相关性：项目Narrative-RFA-EB-11-001第一阶段永旺成像有限责任公司将开发一种低成本、便携式视网膜相机DLP-Cam，为来自不同种族和民族背景的患者提供没有散瞳的高对比度视网膜图像。DLP-Cam将接受糖尿病视网膜病变远程医疗筛查的测试，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病治疗。如果成功，一种便携式和低成本的视网膜相机将显著降低服务不足人群的眼睛护理障碍。

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.