Portable hand-held non-mydriatic retinal camera

描述（由申请人提供）：该项目的长期目标是设计，测试，验证和商业化i-RxCam”，这是一种价格低廉，便携且易于使用的视网膜相机。由于我们第一阶段的技术成就和证明的有效性，我们可以实现第二阶段的总体目标：最终验证和验证低价格的非晶状体视网膜相机，并重新包装I - rxcam”用于制造和商业化。我们对i-RxCam的创新方法主要是基于对当前几代台式和手持商用视网膜成像设备以及正在开发的相机的重大偏离。我们的设计策略是基于广泛的调查、分析和对用户需求的考虑，以确保最大的人体工程学效用。现有的便携式视网膜成像仪，以及已知正在开发的便携式视网膜成像仪，不符合具有足够技术能力（视场、图像质量、便携性、电池电量和易用性）的低价相机的要求，无法广泛分发到可能没有训练有素的视网膜摄影师的医疗诊所。我们将通过两个具体目标来实现第二阶段的目标：1)在第一阶段原型相机设计的基础上构建和组装两台新相机，但要做一些小的改变，以提高可用性和降低成本；2)重新设计一个先进的原型，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仪对可用性的反馈。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，将被用作设备台架测试中的指标。在第二阶段，我们将进行设计更改，以改进以下方面：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。我们将在一组N=224名受试者中进行广泛的临床试验，受试者由至少两名不同水平的视网膜成像经验的摄影师进行成像。来自用户的测试和反馈将用于为大批量生产做准备，同时将商品和制造成本限制在2,000美元以下，并保持小占地面积和便携性要求。我们将进行必要的质量和安全性研究，以生产可提交FDA市场许可的商用设备。“i-RxCam”是昂贵视网膜相机的廉价替代品，它的发展符合美国国立卫生研究院的目标，即减少农村和服务不足人口的医疗保健差距。

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.