Diabetic Retinopathy Diagnosis Device

描述（由申请人提供）：本申请的长期目标是开发一种用于早期检测、诊断和量化糖尿病视网膜病变（DR）中中周边视网膜缺血程度的成像设备。DR是糖尿病的一种更令人衰弱的潜在结果，对糖尿病患者的生活质量构成重大威胁。专家认为，DR是工业化国家25至74岁人群失明的主要原因。美国眼科学会指出，DR是美国工作人群失明的主要原因，目前影响着美国近700万人，早期检测可以帮助治疗DR并挽救约90%的视力丧失，但约三分之一的糖尿病患者仍未确诊。在美国，约有570万人患有糖尿病。在糖尿病的初步诊断中的延迟使得糖尿病并发症在检测之前显著进展，进一步增加了与糖尿病相关的风险。使治疗更加复杂。糖尿病管理指南提倡在疾病预后的早期开始治疗干预。据估计，美国糖尿病患者的DR范围从15%到高达40%。Neuro Kinetics糖尿病筛查方法的目标是在患者发生增殖性DR或重度糖尿病黄斑水肿之前检测DR的主要影响或血管损伤直接导致的继发现象。利用分析和实验方法的组合来开发原型成像设备以验证成像设备将包括以下具体目标：（1）开发用于早期检测、诊断和定量DR中的中周边视网膜缺血程度的原型成像硬件-最重要的问题是系统的硬件设计;（2）开发原型软件，该软件将修改Neuro Kinetics现有的I-Portal（TM）软件，并用DR筛选特定刺激呈现和结果分析软件对其进行补充; 3）对正常和晚期DR患者的有限样本进行概念验证测试;以及4）分析数据并准备II期SBIR计划，以在DR的整个严重程度范围内评估测试算法的灵敏度和特异性。DR的早期诊断可以促进在可以防止或减轻疾病破坏的永久性损伤的阶段的干预，提高患者的生活质量并降低终生治疗成本。专家认为，糖尿病视网膜病变是工业化国家25至74岁人群失明的主要原因。人们普遍认为，我们目前的眼科护理提供系统不能满足这些患者的筛查需求，依赖于眼科护理专业人员的传统临床眼科检查。Neuro Kinetics建议开发一种快速，非侵入性的筛查技术，该技术基于眼睛如何对独特的光模式做出反应的图像，以增加早期诊断的机会。

DESCRIPTION (provided by applicant): The long-term objective of this application is to develop an imaging device for the early detection, diagnosis and quantification of the degree of midperipheral retinal ischemia in Diabetic Retinopathy (DR). DR is one of the more debilitating potential outcomes of diabetes posing a major threat to the quality of life of diabetics. Experts believe that DR is the leading cause of blindness in the industrialized world in people between the ages of 25 and 74 years old. The American Academy of Ophthalmology states that DR is the leading cause of blindness among working Americans and currently affects nearly seven million people in the U.S. Early detection can help treat DR and salvage about 90 percent of vision loss, but about one-third of the diabetic population remains undiagnosed, translating into approximately 5.7 million people in the U.S. Delay in the primary diagnosis of diabetes allows diabetic complications to progress significantly before detection further increasing the risks associated with the disease by making the treatment much more complicated. Diabetes management guidelines advocate initiation of therapeutic intervention early in the prognosis of the disease. Estimates of diabetics in the U.S. with DR range from 15% to as high as 40%. The goal of Neuro Kinetics diabetic screening methodology is to detect the primary effects of DR or secondary phenomena that are the direct result of vascular damage, well before the patients develop proliferative DR or severe diabetic macular edema. To develop a prototype imaging device using a combination of analytical and experimental methods to validate the imaging device will include the following specific aims: (1) develop the prototype imaging hardware for early detection, diagnosis, and quantification of the degree of midperipheral retinal ischemia in DR - the most significant issue is the hardware design of the system; (2) develop prototype software that will modify Neuro Kinetics existing I-Portal(tm) software and supplement it with DR screening specific stimulus presentation and results analysis software; 3) perform proof-of-concept testing on a limited sample of normal and advanced DR patients; and 4) analyze data and prepare a Phase II SBIR plan to assess the sensitivity and specificity of the testing algorithm over a full range of severity of DR. Earlier diagnosis of DR could facilitate intervention at a stage that may prevent or lessen permanent damage from the ravages of the disease in turn, improving patient quality of life and reducing lifetime treatment costs. Experts believe that Diabetic Retinopathy is the leading cause of blindness in the industrialized world in people between the ages of 25 and 74 years old. There is wide spread agreement that our current eye care delivery system cannot meet the screening needs of these patients by relying on traditional clinical eye examinations by eye care professionals. Neuro Kinetics proposes to develop a rapid, noninvasive screening technology based on images of how the eye responds to unique patterns of light to increase the opportunity for earlier diagnosis.