System for Increasing Patient Access to Eye Exams for Diabetic Retinopathy

项目摘要/摘要-EY020017第二阶段B竞争性续订 建议的SBIR计划的总体目标是实施和评估低成本、便携式视网膜 用于糖尿病视网膜病变(DR)筛查的初级保健系统中的DLP-Cam摄像机。未经治疗的DR HAS 在全世界未得到充分服务的人群中达到流行水平。为了充分解决这个问题，DR筛查必须 从患者的初级保健提供者无缝地引导到挽救视力的治疗，并且必须广泛提供 对服务不足的人，例如在社区诊所环境中。 永旺成像有限责任公司，与印第安纳大学验光学院和加州大学伯克利分校合作 验光眼科中心，正在应对为缺乏服务的人提供眼部护理的公共卫生挑战 开发具有成本效益的DR筛查摄像头和基于互联网的远程医疗平台。在第二阶段， EY020017，超过1900名未得到充分服务的糖尿病患者，其中90%以上是种族/少数民族， 在阿拉米达县四家医疗中心社区诊所使用永旺激光扫描数字成像 LSDC相机与商用眼底相机和OCT相机进行比较。图像和去识别成像 会话数据被传输到永旺的云服务器和基于Web的EyePACS进行审查和分析 远程眼科平台由加州大学伯克利分校开发，在美国和国际上超过190个地点使用。 在这一第二阶段的续订中，永旺寻求完成成功将其小说商业化的最后步骤 用于可持续DR筛查的DLP-Cam技术。永旺的DLP-Cam提供高对比度、共焦视角 在自然显示的红色/绿色图像中的视网膜，或红色或绿色的单色图像，避免蓝色 灯。不需要扩大瞳孔。小巧轻便、微处理器控制、可上网的DLP- 凸轮可从标准裂隙灯风格的对准底座上拆卸，便于运输。预计价格为 远远低于竞争对手的产品。与EY020017一样，数据将自动加密并上传到Secure 用于审查和推荐建议的服务器。 DLP-Cam的临床验证将由领先的Joslin Vision Network(JVN)进行 国际糖尿病研究组织。永旺还将测试DLP-Cam与 3个初级保健站点的工作流程和管理的糖尿病患者护理，初级保健提供者(PCP)将 接受视网膜图像评估方面的培训。在此DR筛查模型中，推荐决策被传达 在患者就诊时，以提高对建议的眼睛护理的依从性。认证的远程医疗 图像分级员为筛选系统提供质量保证，并为培训提供持续的图像反馈。 在少数族裔和未得到充分服务的人群中，与糖尿病相关的眼科护理的差距越来越大，需要 解决方案，如DLP-Cam，有效地筛查眼病，从而帮助PCP提供 管理性护理和提高糖尿病患者的意识。如果成功，DLP-Cam将被 PCP将使广泛、高效和可持续的DR筛查成为可能，从而减少眼睛护理的障碍。

Project Summary / Abstract - EY020017 Phase IIB Competitive Renewal The overall goal of the proposed SBIR program is to implement and evaluate a low cost, portable retinal camera, the DLP-Cam, in a primary care system for diabetic retinopathy (DR) screening. Untreated DR has reached epidemic levels in underserved populations worldwide. To fully address this issue, DR screening must lead seamlessly from a patient's primary care provider to vision-saving treatment and must be widely available to the underserved, for instance within a community clinic setting. Aeon Imaging LLC, in partnership with the Indiana University School of Optometry and the UC Berkeley Optometric Eye Center, is addressing the public health challenge of providing eyecare to the underserved by developing cost-effective DR screening cameras and internet-based telemedicine platforms. In Phase II of EY020017, over 1,900 underserved diabetic patients, of which over 90% were racial/ethnic minorities, were imaged at four Alameda County Medical Center community clinics using Aeon's Laser Scanning Digital Camera (LSDC), and commercial fundus and OCT cameras for comparison. Images and de-identified imaging session data are transferred for review and analysis to Aeon's cloud server and to EyePACS, a web-based teleophthalmology platform developed by UC Berkeley and used in over 190 US and international sites. In this Phase IIB Renewal, Aeon seeks to complete the final steps to successfully commercialize its novel DLP-Cam technology for sustainable DR screening. Aeon's DLP-Cam provides high contrast, confocal views of the retina in natural appearing red/green color images, or monochrome in either red or green, avoiding blue light. No pupil dilation is needed. The compact and lightweight, microprocessor controlled, internet ready DLP- Cam is detachable from a standard slit-lamp style alignment base for ease of transport. The projected price is well below competing products. As in EY020017, data will be automatically encrypted and uploaded to secure servers for review and referral recommendations. Clinical validation of the DLP-Cam will be performed by the Joslin Vision Network (JVN), a leading international diabetes research organization. Aeon will also test the integration of the DLP-Cam into the workflow and managed diabetic patient care at 3 primary care sites, where primary care providers (PCPs) will be trained in the evaluation of retinal images. In this DR screening model, referral decisions are communicated at the time of a patient's visit to increase compliance with recommended eye care. Certified telemedicine image graders provide quality assurance of the screening system, and ongoing image feedback for training. The growing disparity in diabetes-related eye care among minority and underserved populations requires a solution such as the DLP-Cam that effectively screens for eye disease, thus assisting PCPs in providing managed care and promoting awareness among diabetic patients. If successful, the DLP-Cam's adoption by PCPs will enable widespread, efficient, and sustainable DR screening, thereby reducing barriers to eye care.