Diabetic Retinopathy Diagnosis Device

糖尿病视网膜病变诊断仪

• 批准号: 7219861
• 负责人: ALEXANDER D KIDERMAN
• 金额: $ 16.26万
• 依托单位: NEUROLIGN USA, LLC
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7219861
• 关键词: Academy; Advocate; Affect; Age; Agreement; Algorithms; American; Back; Blindness; Blood Vessels; Caliber; Caring; Clinical; Complications of Diabetes Mellitus; Computer software; Data Analyses; Detection; Development; Development Plans; Devices; Diabetes Mellitus; Diabetic Retinopathy; Diagnosis; Disease; Early Diagnosis; Eye; Feedback; Frequencies; Goals; Guidelines; Image; Imaging Device; Intervention; Ischemia; Kinetics; Light; Measures; Methodology; Methods; Monitor; Ophthalmic examination and evaluation; Ophthalmology; Outcome; Patients; Pattern; Phase; Play; Population; Protocols documentation; Pupil; Quality of life; Range; Reaction Time; Reporting; Risk; Sampling; Screening procedure; Sensitivity and Specificity; Severities; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Staging; Stimulus; System; Technology; Test Result; Testing; Therapeutic Intervention; Translating; Treatment Cost; Work; base; care delivery; concept; design; diabetes management; diabetic; improved; insight; macular edema; outcome forecast; prevent; proliferative diabetic retinopathy; prototype; response; retinal ischemia

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.

描述（由申请人提供）：本申请的长期目标是开发成像装置，用于早期检测，诊断和定量糖尿病性视网膜病（DR）中末期视网膜缺血程度。 DR是对糖尿病质量构成重大威胁的糖尿病的更令人衰弱的潜在结果之一。专家认为，在25至74岁的人群中，DR是工业化世界中失明的主要原因。美国眼科学会指出，DR是美国工作人员失明的主要原因，目前影响美国近700万人的早期发现可以帮助治疗和挽救视力丧失的约90％，糖尿病人口的约90％，但大约三分之一的糖尿病人仍未诊断，但在糖尿病的主要诊断中延迟了较大的疾病，在糖尿病的主要诊断中延迟了大约570万人通过使治疗更加复杂来疾病。糖尿病管理指南主张在疾病预后初期开始治疗干预。美国DR的糖尿病患者的估计量从15％到高达40％。神经动力学糖尿病筛查方法的目的是检测DR或次要现象的主要作用，这是血管损伤的直接结果，在患者发生增殖性DR或严重的糖尿病黄斑水肿之前。使用分析和实验方法来开发原型成像设备来验证成像设备将包括以下特定目的：（1）开发原型成像硬件，以供早期检测，诊断和量化DR中外面视网膜中期缺血程度的量化 - 最重要的重要问题是该系统的硬件设计； （2）开发原型软件，该软件将修改神经动力学现有的I-portal（TM）软件，并通过DR筛选特定的刺激表现和结果分析软件进行补充； 3）对有限的正常和晚期DR患者样本进行概念验证测试； 4）分析数据并准备II期SBIR计划，以评估在DR的全范围内测试算法的灵敏度和特异性。早期对DR的诊断可能会促进干预阶段，该阶段可能会防止或减少疾病破坏的永久损害，从而提高患者的生活质量并降低终生治疗成本。专家认为，糖尿病性视网膜病是25至74岁的人群工业化世界中失明的主要原因。有广泛的同意，我们当前的眼保健输送系统无法通过依靠眼保健专业人员进行传统的临床眼科检查来满足这些患者的筛查需求。 Neuro动力学建议根据眼睛如何响应独特的光模式以增加早期诊断的机会，以开发快速，无创筛查技术。