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

描述(申请人提供)：这项申请的长期目标是开发一种成像设备，用于早期检测、诊断和量化糖尿病视网膜病变(DR)的中周视网膜缺血程度。早期诊断DR有助于在某个阶段进行干预，以防止或减轻疾病造成的永久性损害，进而提高患者的生活质量，降低终生治疗成本。糖尿病视网膜病变是对糖尿病患者的生活质量构成重大威胁的一种更具破坏性的潜在后果。专家认为，糖尿病是工业化国家25岁至74岁人群失明的主要原因。美国眼科学会表示，糖尿病视网膜病变是美国职场人士致盲的主要原因，目前在美国有近700万人受到影响。早期发现可以帮助治疗糖尿病视网膜病变，挽救约90%的视力丧失，但约三分之一的糖尿病人口仍未得到诊断，这意味着美国约有570万人未确诊。糖尿病的初步诊断延迟使糖尿病并发症在发现之前显著进展，使治疗变得更加复杂，从而进一步增加了与疾病相关的风险。糖尿病管理指南主张在疾病预后的早期启动治疗干预。据估计，在美国，糖尿病视网膜病变患者的比例从15%到40%不等。Neuro Kinetics糖尿病筛查方法的目标是使用一种非侵入性、客观的方法来衡量糖尿病对周边视网膜的损害，这种损害会导致中心视力丧失和可能出血和结疤的异常血管的生长，从而导致失明。与现有的使用眼后部摄影和阅读中心的筛查方法不同，该设备可以为患者和/或他们的医生提供关于疾病严重程度的即时答案，并指示是否需要立即进行专门的眼睛护理。通过比较个体的瞳孔对指向视觉中心或周边视觉的不同亮度光线的反应，我们可以检测到DR对视网膜的进行性损害，同时控制白内障、药物和自主神经功能障碍的影响。我们来自第一阶段研究的初步数据已经建立了测试条件，似乎能够区分中度或重度DR患者与正常人的假阳性率低于1：1000的正常人。我们第二阶段的具体目标如下：(1)开发设备的临床版本，该设备设备齐全，能够在照明区域更容易、更快速地操作；(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名正常和糖尿病患者进行临床测试，以确定仪器作为筛查工具的辨别能力；以及(4)开发商业化前FDA批准和测试的应用程序。 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职场人士失明的主要原因，目前在美国有近700万人受到影响。人们普遍认为，目前美国的眼科保健服务系统无法通过依赖传统的临床眼科检查来满足这些患者的筛查需求。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线模式的反应图像，以在需要干预和治疗以保护视力的阶段检测糖尿病造成的视网膜损伤。

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.