Portable Retinal Imaging Device for Urgent Referrals and Remote Treatment

描述（由申请人提供）：拟议的SBIR项目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已在全世界服务不足的人群中达到流行病水平。护理费用、患者意识和教育以及以社区为基础的疾病治疗不足都是造成目前眼科护理差距的原因。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群广泛提供DR筛查，然后进行视力保护治疗。为了应对日益增长的眼科保健差距，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- Cam将提供高对比度的视网膜共聚焦视图，而不需要扩张，并且预计生产成本大大低于竞争产品。DLP-Cam将很容易从标准的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，并允许眼科保健专家手持视网膜成像。DLP-Cam将提供通常用于DR筛选的无红色图像，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（在患者摄入荧光素染料后）将发现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，以供审查和推荐。在第一阶段，永旺将制造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

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.