Developing a Noninvasive Method and Device for Assessing the Degree of Midperiphe

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的早期诊断可以促进在一个阶段的干预，可以预防或减轻疾病造成的永久性损伤，从而提高患者的生活质量并降低终身治疗费用。 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使用一种非侵入性的、客观的方法来测量糖尿病相关的周边视网膜损伤，这种损伤有助于中心视力丧失的发展和异常血管的生长，这些血管可能会出血和瘢痕，导致失明。与采用眼睛后部和阅读中心的摄影的现有筛查方法不同，该设备可以向患者和/或他们的医生提供疾病严重程度的即时答案，并指示是否需要立即进行专业眼部护理。通过比较个体瞳孔对指向视觉中心或周边视觉的不同亮度的光的反应，我们可以检测DR的进行性视网膜损伤，同时控制白内障，药物和自主神经功能障碍的影响。我们从I期研究中获得的初步数据已经建立了似乎能够区分中度或重度DR个体与正常个体的测试条件，正常人的假阳性率小于1：1000。 我们在第二阶段有以下具体目标：（1）开发一种临床版本的测试设备，该设备是独立的，可以在照明区域更容易和快速地操作;（2）开发控制、记录和自动分析软件，用于评估数据质量和解释;（3）对总共200名正常人和糖尿病受试者进行临床测试，以确定该仪器作为筛查工具的辨别能力，以及（4）开发用于预商业FDA批准和测试。 公共卫生相关性：根据美国眼科学会的数据，糖尿病视网膜病变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，人们普遍认为，目前美国的眼科护理提供系统无法满足这些患者的筛查需求，依赖传统的临床眼科检查。Neuro Kinetics正在开发一种快速，非侵入性的筛查技术，该技术基于瞳孔对独特光模式的反应图像，以检测糖尿病视网膜损伤，从而保证干预和治疗以保护视力。

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). 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. 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 use a noninvasive, objective measure of diabetes-related damage to the peripheral retina that contributes to the development of central vision loss and the growth of abnormal blood vessels that can bleed and scar, leading to blindness. Unlike existing screening methods which employ photography of the back of the eye and reading centers, this device can provide an instantaneous answer to the patient and/or their doctor of the severity of the disease and indicate if immediate specialty eye care is warranted. By comparing the responses of an individual's pupil to varying brightness of lights directed either to the center of vision or to the peripheral vision, we can detect progressive retinal damage from DR while controlling for the effects of cataracts, medications, and autonomic dysfunction. Our preliminary data from a Phase I study has established testing conditions that appear to be capable of distinguishing individuals with moderate or severe DR from normal individuals with less than a 1:1000 false positive rate for normal people. We have the following specific aims for Phase II: (1) to develop a clinical version of the testing device that is self-contained and can operate more easily and rapidly in a lighted area; (2) to develop control, recording and automatic analysis software for assessment of data quality and interpretation; (3) to perform clinical testing on a total of 200 normal and diabetic subjects to establish the discrimination capabilities of the instrument as a screening tool and (4) to develop an application for pre-commercial FDA approval and testing. PUBLIC HEALTH RELEVANCE: According to the American Academy of Ophthalmology, Diabetic Retinopathy is the leading cause of blindness among working Americans and currently affects nearly seven million people in the U.S. There is widespread agreement that the current U.S. eye care delivery system cannot meet the screening needs of these patients by relying on traditional, clinical eye examinations. Neuro Kinetics is developing a rapid, noninvasive screening technology based on images of the pupil's response to unique patterns of light to detect retinal damage from diabetes at a stage that would warrant intervention and therapy to protect sight.