Screening Device for Diabetic Retinopathy

糖尿病视网膜病变筛查装置

• 批准号: 8010744
• 负责人: C Quentin Davis
• 金额: $ 64.83万
• 依托单位: LKC TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8010744
• 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; diabetic; diabetic patient; digital; instrument; light intensity; prototype; public health relevance; retinal ischemia

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）：本提案的目的是开发一种廉价的手持设备，可供主要护理人员（例如全科医生、内科医生和内分泌科医生）使用，并在筛查环境中可靠地筛查高危糖尿病患者。视网膜病变并立即提供结果。该设备有可能通过识别糖尿病患者的病情并及时转诊至眼科医生进行评估和治疗，从而挽救数千名未发现糖尿病视网膜病变的糖尿病患者的视力。该设备的工作原理是测量 30 Hz 闪烁视网膜电图的隐式时间，该时间已被反复证明与糖尿病视网膜病变的严重程度密切相关。由于该设备测量隐式时间，因此它将通过放置在眼睛附近的皮肤电极进行记录。设备将自动检测电极接触是否良好。将自动测量瞳孔大小，并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发波形的隐式时间，结果将与测量可靠性的估计一起显示给护理人员。 LKC Technologies 已经拥有开发该设备所需的大部分技术，特别是紧凑型低噪声、抗饱和数字患者放大器、用于控制 LED 光输出的复杂电路以及经过验证的分析算法。在第一阶段，通过使用现成的瞳孔计和定制软件修改 LKC UTAS 视觉电生理学系统，开发了原理验证原型。记录数据以评估测量信号质量和提取隐式时间的算法的稳健性，并确定最佳刺激参数。在第二阶段，将建造一个完整的手持式原型仪器，并在筛查环境中从大量糖尿病患者中收集数据，以证明该设备的有效性。另一项研究将招募患有不同程度糖尿病视网膜病变的患者，以评估该设备在各种视网膜病变中的有用性。 公共卫生相关性： 相关性 美国有 2400 万人患有糖尿病；其中 500 万人患有某种程度的糖尿病视网膜病变，这是导致工作年龄成年人失明的主要原因。尽管每年在与糖尿病视网膜病变相关的医疗保健上花费 4.93 亿美元，但今年美国仍有 18,000 人将因这种疾病失明。许多糖尿病患者不知道自己患有糖尿病视网膜病变，因为没有快速、简单、廉价且广泛可用的筛查方法。该项目旨在开发一种紧凑、易于使用、经济高效的设备，使有视网膜病变风险的糖尿病患者能够在初级保健或筛查环境中快速、廉价地得到评估，并转诊接受治疗以保留视力。