Screening Device for Diabetic Retinopathy

糖尿病视网膜病变筛查装置

基本信息

批准号：
8447133
负责人：
C Quentin Davis
金额：
$ 11.65万
依托单位：
LKC TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-01 至 2013-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8447133
关键词：
Adhesives Adult Age Algorithms Amplifiers Blindness Caliber Caregivers Charge Clinical Computer software Custom Data Devices Diabetes Mellitus Diabetic Retinopathy Disease Effectiveness Electrodes Electronics Electrophysiology (science)Electroretinography Endocrinologist Environment Evaluation Eye General Practitioners Goals Grant Healthcare International Internist Light Measurement Measures Mechanics Methods Monitor Noise Ophthalmologist Output Patients Performance Phase Population Primary Health Care Pupil Recruitment Activity Resistance Retinal Retinal Diseases Risk Screening procedure Severities Severity of illness Signal Transduction Skin Stimulus System Technology Testing Time United States Vision Visual Work Writing base blind clinically significant cost effective diabetic diabetic patient digital instrument light intensity prototype public health relevance retinal ischemia

项目摘要

DESCRIPTION (provided by applicant): The aim of this proposal is to develop an inexpensive, handheld device that can be used by primary caregivers (such as general practitioners, internists, and endocrinologists) and in screening settings to reliably screen at-risk diabetics for retinopathy and provide immediate results. This device has the potential to save the sight of thousands of diabetics who have undetected diabetic retinopathy by identifying their condition and allowing timely referral to an ophthalmologist for evaluation and treatment. The device works by measuring the implicit time of the 30 Hz flicker electroretinogram, which has been repeatedly shown to correlate well with severity of diabetic retinopathy. Because the device measures implicit time, it will record from skin electrodes placed near the eye. The device will automatically detect good electrode contact. Pupil size will be automatically measured and the light intensity will be adjusted to provide an optimal retinal stimulus. Proven algorithms will be used to measure the implicit time from the elicited waveform, and the results will be displayed to the caregiver along with an estimate of the reliability of the measurement. LKC Technologies already possesses most of the technologies necessary to develop this device, notably compact low noise, saturation-resistant digital patient amplifiers, sophisticated circuitry for controlling the light output of LEDs, and proven analysis algorithms. In Phase I, a proof-of-principle prototype was developed by modifying an LKC UTAS visual electrophysiology system with an off-the shelf pupillometer and custom software. Data were recorded to assess the robustness of the algorithms for measuring signal quality and extracting implicit time and to determine optimal stimulus parameters. In Phase II, a complete handheld prototype instrument will be constructed, and data will be collected from a large population of diabetics in a screening environment to demonstrate the effectiveness of the device. An additional study will recruit patients with varying levels of diabetic retinopathy to evaluate the usefulness of the device over a wide range of retinopathy. PUBLIC HEALTH RELEVANCE: Relevance Twenty-four million people in the United States suffer from diabetes; five million of them have some degree of diabetic retinopathy - the leading cause of blindness in working-age adults. Although $493 million is expended annually for healthcare related to diabetic retinopathy, another 18,000 people in the United States will go blind this year from the disease. Many diabetics do not know that they have diabetic retinopathy because there is no quick, easy, inexpensive, and widely available screening method. This project proposes to develop a compact, easy-to-use, cost-effective device that would allow diabetics at risk for retinopathy to be evaluated quickly and inexpensively in primary care or screening environments and referred for treatment to preserve their sight.

描述（由申请人提供）：该提案的目的是开发一种廉价的手持设备，该设备可以由主要护理人员（例如全科医生，内科医生和内分泌学家）使用，并在筛查设置中可靠地筛选处于风险的糖尿病患者，以用于视网膜病变，并提供直接的结果。该设备有可能通过识别其病情并及时转介给眼科医生进行评估和治疗，从而节省数千种糖尿病患者的视线。该设备通过测量30 Hz闪烁电子图的隐式时间来起作用，该图已反复证明与糖尿病性视网膜病的严重程度很好地相关。由于设备测量了隐式时间，因此它将记录在靠近眼睛的皮肤电极中。该设备将自动检测到良好的电极触点。瞳孔大小将自动测量，并将调整光强度以提供最佳的视网膜刺激。经过验证的算法将用于测量引起的波形的隐式时间，结果将显示给护理人员，以及测量可靠性的估计。 LKC技术已经拥有开发该设备所需的大多数技术，特别是紧凑的低噪声，耐饱和的数字患者放大器，用于控制LED的光输出的复杂电路以及经过验证的分析算法。在第一阶段，通过使用较低的架子划分计和自定义软件修改LKC UTAS Visual电生理系统来开发原始原型。记录数据以评估算法的鲁棒性，以测量信号质量并提取隐式时间并确定最佳刺激参数。在第二阶段，将构建完整的手持原型仪器，并将在筛查环境中从大量的糖尿病患者中收集数据，以证明设备的有效性。另一项研究将招募患有不同水平的糖尿病性视网膜病变的患者，以评估该设备在广泛的视网膜病变中的有用性。公共卫生相关性：美国有2400万人患有糖尿病；其中有五百万患有一定程度的糖尿病性视网膜病 - 在工作年龄成年人中失明的主要原因。尽管每年花费4.93亿美元用于与糖尿病性视网膜病有关的医疗保健，但今年，美国另外18,000人将对这种疾病失明。许多糖尿病患者不知道它们患有糖尿病性视网膜病，因为没有快速，简单，廉价且可用的筛查方法。该项目提议开发一种紧凑，易于使用，具有成本效益的设备，该设备将使糖尿病患者在初级保健或筛查环境中快速，廉价地评估视网膜病的危险，并转介治疗以保持其视力。