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成像设备，用于糖尿病视网膜病变（DR）中周围视网膜缺血程度的早期检测、诊断和量化。DR的早期诊断可促进在某一阶段进行干预，从而预防或减轻疾病造成的永久性损害，进而改善患者的生活质量并降低终生治疗费用。DR是糖尿病较为衰弱的潜在后果之一，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岁至74岁人群失明的主要原因。美国眼科学会指出，DR是美国工人失明的主要原因，目前美国有近700万人受到影响。早期发现DR可以帮助治疗DR，挽救约90%的视力丧失，但约三分之一的糖尿病患者仍未得到诊断。糖尿病早期诊断的延迟使得糖尿病并发症在发现之前显著进展，进一步增加了与疾病相关的风险，使治疗变得更加复杂。糖尿病管理指南提倡在疾病预后早期开始治疗干预。据估计，美国患有DR的糖尿病患者比例从15%到高达40%不等。神经动力学糖尿病筛查方法的目标是使用一种无创的、客观的方法来测量糖尿病对周围视网膜的损害，这种损害会导致中枢性视力丧失和异常血管的生长，这些血管会出血和疤痕，导致失明。与现有的使用眼后部和阅读中心摄影的筛查方法不同，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科护理。通过比较一个人的瞳孔对不同亮度的光的反应，无论是对视觉中心还是对周边视觉，我们可以在控制白内障、药物和自主神经功能障碍的影响的同时，检测出DR的进行性视网膜损伤。我们一期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，正常人的假阳性率低于1:1000。我们对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；（二）开发用于数据质量评估和解释的控制、记录和自动分析软件；(3)对共200名正常人和糖尿病受试者进行临床试验，以建立该仪器作为筛选工具的识别能力；(4)开发商业化前FDA批准和测试的申请。

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.