Compact, cost-effective, and operator-friendly fundus camera for early detection

描述（由申请人提供）：该SBIR应用将通过开发一种易于使用、口袋大小、廉价的数码相机来记录视网膜和视神经疾病，从而彻底改变常规检查眼后部的方法。为了降低可预防的视力丧失率，早期诊断可治疗的眼病变得越来越重要，特别是随着全球人口老龄化。早期疾病诊断对保护视网膜和视神经功能至关重要。广泛使用的直接检眼镜是常规使用，但只是有困难。它的视野很小， 影像转瞬即逝，不留任何检查记录。虽然在世纪中期发明时具有开创性，但这种仪器不再是全球减少视力丧失的最先进工具。传统的眼底照相机是一种有价值的技术，但它们昂贵且笨重，通常由资金充足的眼科护理中心的训练有素的技术人员使用。因此，缺乏高质量的视网膜检查使许多人面临视力丧失的风险。在一个小的人体工程学设计，新的相机大大简化眼底成像。高质量的照片是通过使相机的光滑前端与病人的麻醉角膜短暂接触来获得的。图像采集和分析在接触时自动执行，并且听觉信号通知检查者过程完成。图像被保存在内部，并可以无线传输到附近的计算机进行可视化和存档存储。一旦最终用户意识到该产品的价值，对角膜接触的担忧将消失，这种新的相机将取代具有21世纪技术的直接检眼镜。该第二阶段计划旨在开发相机的光学，机械，电子和图像分析方面，这些方面必须符合许多苛刻的性能和小型化规格。该项目的成果将是几个经过临床测试的商业原型，可以向潜在的投资者和客户展示，例如大型眼科公司或最终用户。它将作为III期大批量生产工艺开发、注册研究和上市的基础。 公共卫生相关性：所提出的超便携式手持无线眼底相机提供了一种有效和简单的方法来检查人类视网膜和记录的结果。它取代了直接检眼镜，成为一种更可靠、更先进的医疗设备。这些图像可以在常规访问初级保健提供者或专家以及其他高容量环境中收集，从而降低视力丧失率并降低医疗保健成本，并改善数百万人的生活质量。

DESCRIPTION (provided by applicant): This SBIR application will revolutionize the methodology for routine examination of the back of the eye by developing an easy-to-use, pocket-sized, inexpensive digital camera for documenting retinal and optic nerve diseases. In order to reduce rates of preventable vision loss, the early diagnosis of treatable eye diseases has become increasingly important, especially as the global population ages. Early disease diagnosis is vital to preserving retinal and optic nerve function. The widely available direct ophthalmoscope is used routinely but only with difficulty. It has a small field of view, provides a fleeting image and leaves no examination record. Although ground-breaking when it was invented in the mid-19th century, this instrument is no longer a cutting edge tool in global effort to reduce vision loss. Traditional fundus cameras are a valuable technology, but they are expensive and bulky, and are typically used by trained technicians in well funded eye care centers. As a result, a lack of a quality retinal examination puts many people at risk for vision loss. Housed in a small ergonomic design, the new camera drastically simplifies fundus imaging. Quality photographs are obtained by bringing the smooth front tip of the camera into brief contact with a patient's anesthetized cornea. Image acquisition and analysis is performed automatically upon contact, and an audible signal informs the examiner the process is complete. The images are saved internally and can be wirelessly transmitted to a nearby computer for visualization and archival storage. Once the end user realizes the value of this product, concerns regarding corneal contact will dissipate, and this new camera will replace the direct ophthalmoscope with 21st century technology. This Phase II program is aimed at developing optical, mechanical, electronic and image analysis aspects of the camera, which must conform to a number of demanding performance and miniaturization specifications. The outcome of this project will be several clinically tested commercial prototypes, which can be exhibited to potential investors and customers, such as large ophthalmic companies or end users. It will serve as the basis in Phase III for high-volume manufacturing process development, registration studies, and launch. PUBLIC HEALTH RELEVANCE: The proposed ultra-portable hand-held wireless fundus camera provides an effective and simple approach to inspecting the human retina and documenting the findings. It replaces the direct ophthalmoscope as a more reliable and advanced medical device. The images can be collected during routine visits to primary care providers or specialists and in other high volume settings thereby reducing rates of vision loss and lowering health care costs, and improving the quality of life for millions of people.