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）：本项目的长期目标是设计、测试、验证和商业化i-RxCam，这是一种低价、便携且易于使用的视网膜相机。由于我们在第一阶段的技术成就和已证明的有效性，我们可以实现第二阶段的总体目标：最终验证和确认低价的非散瞳视网膜相机，并重新包装i-RxCam”用于生产和商业化。i-RxCam”的创新方法主要基于与当前几代台式和手持式商用视网膜成像设备以及正在开发的相机的显著不同。我们的设计策略基于对用户需求的广泛调查、分析和考虑，以确保最大的人体工程学效用。现有的便携式视网膜成像器以及已知正在开发的那些不满足具有足够的技术能力（视场、图像质量、便携性、电池功率和易用性）的低价格相机的要求，以广泛地分发到可能无法获得受过训练的视网膜摄影师的医疗实践的办公室。我们将通过两个具体目标来实现第二阶段的目标：1）基于最终确定的第一阶段原型相机设计，制造和组装两台新相机，但进行微小的更改以提高可用性并降低成本; 2）重新设计先进的原型，将视野从32度增加到45度。这两款相机都将在临床环境中进行测试。测试的指标将是成像人员对可用性的反馈。阅读的可接受图像的百分比将是第二个度量。定量指标（如分辨率、对比度和动态范围）将用作器械台架测试的指标。在第二阶段，我们将进行设计变更，以改善以下方面：更大的视野，更小的瞳孔访问，自动对焦，人体工程学和便携性。我们将在由至少两名具有不同视网膜成像经验水平的摄影师成像的N=224名受试者的队列中进行广泛的临床测试。用户的测试和反馈将用于为大批量生产准备i-RxCam，同时将商品和制造成本限制在2，000美元以下，并保持小尺寸和便携性要求。我们将进行必要的质量和安全性研究，以生产可提交FDA上市许可的商业就绪器械。i-RxCam”是昂贵视网膜相机的低价替代品，其开发符合NIH的目标，即减少农村和服务不足人群的医疗保健差距。