Portable hand-held non-mydriatic retinal camera

便携式免散瞳眼底照相机

• 批准号: 9059720
• 负责人: Peter N Soliz
• 金额: $ 74.68万
• 依托单位: VISIONQUEST BIOMEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-02-01 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9059720
• 关键词: Address; Adoption; Affect; Caring; Clinic; Clinical; Consult; Development; Devices; Diabetes Mellitus; Diagnosis; Disclosure; Doctor of Philosophy; Documentation; Economics; Effectiveness; Electronics; Engineering; Ensure; Environment; Equipment; Feedback; Fundus; Generations; Goals; Government; Hand; Health; Image; Imaging Device; Incidence; Institutes; Legal patent; Lighting; Marketing; Measures; Mechanics; Medical; Medical Device; Minor; Miosis disorder; Modeling; Modification; Optic Disk; Optics; Patients; Performance; Phase; Physician Executives; Population; Price; Primary Health Care; Principal Investigator; Process; Public Health; Reading; Resolution; Retina; Retinal; Retinal Diseases; Risk; Rural; Rural Population; Scientist; Site; Source; South Texas; Surveys; System; Testing; Time; Training; Underserved Population; United States National Institutes of Health; Vision; base; cohort; commercialization; cost; design; disease diagnosis; disparity reduction; ergonomics; experience; imaging system; improved; innovation; innovative technologies; meetings; portability; product development; prototype; research and development; research clinical testing; safety study; screening; success; usability; verification and validation

DESCRIPTION (provided by applicant): The long-term objective of this project is to engineer, test, validate, and commercialize the i-RxCam", a low- priced, portable, and easy to use retinal camera. Because of our Phase I technical accomplishments and demonstrated effectiveness, we can achieve the overarching goal of this Phase II: final verification and validation of the low-priced non-mydriatic retinal camera and repackaging of i-RxCam" for manufacture and commercialization. Our innovative approach for the i-RxCam" is based primarily on a significant departure from current generations of desktop and handheld commercial retinal imaging devices, and those cameras under development. Our design strategy is based on an extensive survey, analysis, and consideration of the user requirements to ensure maximum ergonomic utility. Existing portable retinal imagers, as well as those known to be under development, do not meet the requirements of a low-price camera with sufficient technical capabilities (field of view, image quality, portability, battery power, and ease-of-use) to be distributed widely to the offices of medical practices where trained retinal photographers may not be available. We will achieve the Phase II objectives through two specific aims: 1) to build and assemble two new cameras based on a finalized Phase I prototype camera design, but with minor changes to improve usability and reduce costs; and 2) to re-engineer an advanced prototype that increase the field of view from 32 degrees to 45 degrees. Both cameras will undergo testing in a clinical environment. The metrics for testing will be feedback from imagers on the usability. Percentage of acceptable images for reading will be a second metric. Quantitative metrics, such as resolution, contrast, and dynamic range, will be used as metrics in the bench testing of the devices. In Phase II we will make design changes to improve on the following aspects: larger field of view, smaller pupil access, auto-focus, ergonomics, and portability. We will perform extensive clinical testing in a cohort of N=224 subjects imaged by at least two photographers of differing levels of experience in retinal imaging. The testing and feedback from users will be used to prepare the i-RxCam" for high volume manufacturing, while constraining the cost of goods and manufacture to under $2,000 and maintaining the small footprint and portability requirements. We will conduct the necessary quality and safety studies needed for producing a commercial-ready device that can be submitted for FDA market clearance. The i-RxCam" is a low-priced alternative to expensive retinal cameras, and its development is aligned with the NIH objective to reduce disparities in medical care in rural and underserved populations.

描述（由申请人提供）：该项目的长期目标是工程，测试，验证和商业化I-RxCAM”，这是一种低价，便携式且易于使用的视网膜相机。由于我们的I阶段技术成就并表现出了有效性，我们可以实现此阶段II的总体目标：最终的II级和验证II的总体验证，并重新验证I II级的II级和验证，并重新验证了II级的II级和验证IS，并重新验证I II级的II级和验证'商业化。我们对I-RXCAM的创新方法主要是基于与当前几代台式机和手持商业视网膜成像设备以及正在开发的相机的重大不同。我们的设计策略是基于广泛的调查，分析和对用户的考虑，以确保最大程度地符合现有的摄像机。可以广泛地分配给训练有素的视网膜摄影师的医疗实践的办公室，我们将通过两个特定的目标来实现II阶段的目标，以构建和组装两个新的相机，从而，您将基于最终化的相机设计，从而提高了次要的摄像机，从而提高了两个新的相机在临床环境中，两种摄像机的测试将是对可用性的临床，将在临床上进行30度。查看，较小的学生访问，自动焦点，人体工程学和便携性。我们将进行生产可用于FDA市场许可的商业就绪设备所需的必要质量和安全研究。 I-RXCAM”是昂贵的视网膜相机的低价替代品，其发展与NIH目标一致，以减少农村和服务不足人群的医疗服务差异。