Portable hand-held non-mydriatic retinal camera

描述（由申请人提供）：根据美国国立卫生研究院的数据，美国有超过8000万人患有潜在的视力威胁疾病。医生们每年发现700万到800万新的眼疾病例。超过200万50岁及以上的美国人患有晚期AMD，这一阶段可能导致严重的视力障碍，1000万人患有早期或中期AMD。青光眼影响超过230万40岁及以上的美国人。另有200万青光眼患者未被确诊。美国和世界各地的糖尿病病例一直在上升。不良的饮食习惯和缺乏锻炼，导致2型糖尿病的因素，导致越来越多的超重人口。根据国际糖尿病联合会的数据，截至2010年，世界上有2.85亿糖尿病病例。对于2型糖尿病患者，50%将在疾病诊断的15年内发展为糖尿病视网膜病变。定期进行眼科疾病筛查是必要的，以防止眼科疾病进展到晚期，威胁视力的阶段。该项目的目标是开发和测试一种低成本、手持式、非散瞳视网膜摄像机，用于广泛应用，包括糖尿病视网膜病变、青光眼和与年龄相关的眼病等眼科疾病的远程视网膜筛查。拟议的摄像机满足了一个尚未得到满足的重要需求：成本低（商品成本低于1 500美元）;占地面积小（主要是一个手持装置）;易于使用（符合人体工程学设计，由受过最低限度培训的医疗技术人员或护士操作）。将这项技术引入诊所环境将使服务不足的个人能够接受定期的眼部筛查，而无需前往眼科护理专业人员。为了实现这一目标，我们的建议有两个目标。一是 生产低成本、手持式、非散瞳照相机的原型，该原型将基于已开发的散瞳照相机的早期原型，并且早期测试已显示出其重要功能。该设计是基于低成本，现成的组件，可以很容易地组装一个大批量的市场。其次，我们将在筛查或临床环境中测试这款相机。使相机符合人体工程学，适合由一个最低限度的训练个人使用将是这一目标的目标。将对视野、分辨率和安全性进行定量分析。

DESCRIPTION (provided by applicant): According to the National Institutes of Health, there are more than 80 million people in the US who suffer from a potentially sight-threatening disease. Doctors see seven to eight million new cases of eye disease annually. More than two million Americans age 50 and older have advanced AMD, the stage that can lead to severe vision impairment and 10 million have early or intermediate AMD. Glaucoma affects more than 2.3 million Americans age 40 and older. Another two million individuals with glaucoma are undiagnosed. Diabetes cases in the US and throughout the world have been on the rise. Poor eating habits and lack of exercise, factors which contribute to type 2 diabetes, have led to an increasingly overweight population. According to the International Diabetes Federation, there are 285 million cases of diabetes in the world as of 2010. For the type 2 diabetics, 50% will develop diabetic retinopathy within 15 years of disease diagnosis. Regular eye disease screening is necessary to prevent the progression of eye diseases to advanced, sight-threatening stages. The objective of this project is to develop and test a low-cost, hand-held, non-mydriatic retinal camera for widespread applications, including teleretinal screening for eye diseases such as diabetic retinopathy, glaucoma, and age-related ocular diseases. The proposed camera fills an important unmet need: low-cost (under $1,500 cost of goods); small footprint (principally a hand-held device); and easy to use (ergonomically designed for operation by a minimally trained medical technician or nurse). Introducing this technology to a clinic environment will allow underserved individuals to receive regular eye screenings without traveling to an eye care professional. To meet this goal, our proposal has two aims. First, we will produce a prototype of the low-cost, hand-held, non-mydriatic camera, which will be based on an early prototype of a mydriatic camera that was developed, and for which early testing has shown significant functionality. The design is based on low-cost, off-the-shelf components that can be assembled easily for a high- volume market. Second, we will test this camera in a screening or clinic environment. Making the camera ergonomically suitable for use by a minimally trained individual will be the goal of this aim. Quantitative analysis will be performed as to field of view, resolution, and safety.