System for Increasing Patient Access to Eye Exams for Diabetic Retinopathy

增加患者接受糖尿病视网膜病变眼科检查的系统

• 批准号: 8123309
• 负责人: Matthew S Muller
• 金额: $ 101.22万
• 依托单位: AEON IMAGING, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2013-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8123309
• 关键词: Adult; Age; Algorithms; American; Anterior; Archives; Blindness; Blood Vessels; California; Caring; Cataract; Clinical; Collaborations; Color; Communication; Comparative Study; Computer software; Computer-Assisted Image Analysis; Cost Savings; Custom; Data; Data Analyses; Decision Making; Detection; Development; Devices; Diabetes Mellitus; Diabetic Retinopathy; Diagnostic tests; Dilatation - action; Disease; Early treatment; Electronics; Elements; Eligibility Determination; Enrollment; Ensure; Epidemic; Evaluation; Eye; Eye Color; Feedback; Floods; Foundations; Fundus; Generations; Goals; Health Insurance; Healthcare; Image; Image Analysis; Imaging Device; Indiana; Individual; Internet; Knowledge; Lasers; Legal patent; Light; Lighting; Low income; Measures; Metric; Minority; Miosis disorder; Modeling; Monitor; Motion; Mydriasis; Mydriatics; National Eye Institute; Noise; Online Systems; Ophthalmic examination and evaluation; Ophthalmoscopes; Optic Disk; Optics; Optometry; Participant; Patients; Peer Review; Performance; Phase; Pigments; Preparation; Prevalence; Primary Health Care; Printing; Production; Protocols documentation; Provider; Publishing; Pupil; Quality Control; Readiness; Recommendation; Relative (related person); Reporting; Retina; Retinal; Retinal Diseases; Risk; Sampling; Scanning; Schools; Scotoma; Screening Result; Screening procedure; Sensitivity and Specificity; Services; Signal Transduction; Site; Small Business Innovation Research Grant; Software Tools; Specialist; Specific qualifier value; Speed; Staging; Stream; Structure; Support System; System; Target Populations; Telemedicine; Test Result; Testing; Time; Training; Training Programs; Underserved Population; Universities; Validation; Vision; Visit; Visual impairment; Work; base; checkup examination; clinical research site; commercialization; cost; cost effective; data acquisition; design; diabetic; digital; digital imaging; experience; eye center; health disparity; image registration; improved; instrument; journal article; laptop; lens; macula; meetings; novel; open source; operation; phase 1 study; prevent; programs; prototype; public health relevance; racial and ethnic; response; retinal damage; success; symposium; time use; tool; usability; vitreous floater; volunteer; willingness

DESCRIPTION (provided by applicant): The overall goal of the proposed SBIR program is to implement and evaluate a low cost retinal camera, the Laser Scanning Digital Camera (LSDC), in a system for diabetic retinopathy (DR) screening. Untreated DR has reached epidemic levels in underserved populations worldwide. As the LSDC has already demonstrated its readiness for DR screening in preliminary studies, a Fast-Track proposal is presented. Existing instruments for retinal imaging have been inadequate tools for DR screening as they are too expensive or provide too high a proportion of ungradeable images. Unlike these devices, the patented LSDC design provides a combination of a non-mydriatic design and high contrast retinal images, yet remains low cost and easy to operate. Comfortable near infrared illumination provides strong light return from the retina regardless of eye color. Anterior and posterior segment imaging are real-time. These features allow the LSDC to screen patients with small pupils, darkly pigmented eyes, or moderate cataracts, while providing a sufficiently wide retinal field for analysis. The LSDC will be further developed by Aeon Imaging, using field-testing data and analysis provided by UC Berkeley and Indiana University. Already low cost, LSDC materials and assembly cost savings will be explored further. Apart from low instrument costs, a supporting system that employs trained device operators and graders, including cost-effective and accurate image transfer protocols, is critical for overall DR screening success. Thus, Aeon will partner with an existing clinical communications system, EyePACS, operated by UC Berkeley, that is already providing DR screening and telemedicine referral services to underserved individuals. In Phase I, Aeon, in collaboration with Indiana University, UC Berkeley, and Vision for All, will investigate the performance of the LSDC using trained but non-specialist operators. The initial screening will be feature- based, i.e. the success in detecting specific DR features with the LSDC will be analyzed. The LSDC will be compared against a commercial non-mydriatic fundus camera and a dilated fundus exam. In Phase II, Aeon will incorporate further cost reductions and operator/patient feedback from Phase I studies into the 2nd generation LSDC design. Aeon will also train non-specialist image graders to identify DR features found in LSDC images, and determine whether they can accurately specify which patients require referral for follow-on eye care. A comparative study will determine if screening with the LSDC using trained operators, telemedicine image transfer with EyePACS, and trained image graders matches the independent referral decision made using costlier devices and specialist image analysis. At the conclusion of this study, Aeon will have field-tested the LSDC and the low cost screening system, establishing its capability with respect to costlier approaches. If successful, Aeon will be prepared to expand DR screening operations and help reduce health disparities. PUBLIC HEALTH RELEVANCE: 7. Project Narrative Aeon Imaging, LLC, will further develop a novel and low cost Laser Scanning Digital Camera that has already been shown to produce high contrast retinal images without pupil dilatation in patients from diverse racial and ethnic backgrounds. This retinal imaging device has a sufficiently wide field of view to visualize the optic disc and macula at the same time, and uses comfortable near infrared illumination for real-time imaging. To reduce the overall costs of diabetic retinopathy screening, the success of accurately recommending referral for follow on eye care will be assessed with trained, but non-expert, LSDC operators and image graders.

描述（由申请人提供）：拟议的 SBIR 计划的总体目标是在糖尿病视网膜病变（DR）筛查系统中实施和评估低成本视网膜相机，即激光扫描数码相机（LSDC）。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。由于 LSDC 已在初步研究中证明其已做好 DR 筛查的准备，因此提出了快速通道提案。 现有的视网膜成像仪器不足以用于 DR 筛查，因为它们太昂贵或提供的不可分级图像比例过高。与这些设备不同的是，获得专利的 LSDC 设计结合了免散瞳设计和高对比度视网膜图像，但成本低廉且易于操作。无论眼睛颜色如何，舒适的近红外照明都能从视网膜提供强光返回。眼前节和后节成像是实时的。这些功能使 LSDC 能够筛查瞳孔较小、眼睛色素较深或中度白内障的患者，同时提供足够宽的视网膜视野进行分析。 Aeon Imaging 将利用加州大学伯克利分校和印第安纳大学提供的现场测试数据和分析进一步开发 LSDC。 LSDC 材料和装配成本已经很低，我们将进一步探索其节省成本。除了较低的仪器成本外，采用经过培训的设备操作员和分级人员的支持系统（包括经济高效且准确的图像传输协议）对于整体 DR 筛查的成功至关重要。因此，Aeon 将与加州大学伯克利分校运营的现有临床通信系统 EyePACS 合作，该系统已经为服务不足的个人提供 DR 筛查和远程医疗转诊服务。 在第一阶段，Aeon 将与印第安纳大学、加州大学伯克利分校和 Vision for All 合作，使用经过培训的非专业操作员来调查 LSDC 的性能。初始筛选将基于特征，即将分析使用 LSDC 检测特定 DR 特征的成功情况。 LSDC 将与商用免散瞳眼底相机和散瞳眼底检查进行比较。在第二阶段，Aeon 将进一步降低成本并将第一阶段研究的操作员/患者反馈纳入第二代 LSDC 设计中。 Aeon 还将培训非专业图像分级人员识别 LSDC 图像中发现的 DR 特征，并确定他们是否能够准确指定哪些患者需要转诊进行后续眼部护理。一项比较研究将确定使用训练有素的操作员、使用 EyePACS 进行远程医疗图像传输以及训练有素的图像分级员进行 LSDC 筛查是否与使用更昂贵的设备和专业图像分析做出的独立转诊决策相匹配。在这项研究结束时，Aeon 将现场测试 LSDC 和低成本筛查系统，建立其针对昂贵方法的能力。如果成功，永旺将准备扩大 DR 筛查业务并帮助缩小健康差距。 公共健康相关性： 7. Project Narrative Aeon Imaging, LLC 将进一步开发一种新颖且低成本的激光扫描数码相机，该相机已被证明可以在不同种族和民族背景的患者中产生高对比度视网膜图像，而不会出现瞳孔扩张。这种视网膜成像设备具有足够宽的视野，可以同时观察视盘和黄斑，并使用舒适的近红外照明进行实时成像。为了降低糖尿病视网膜病变筛查的总体成本，将由经过培训的非专家 LSDC 操作员和图像分级员来评估准确推荐转诊进行后续眼部护理的成功与否。