Cost-Effective OCT Detection of Vision-Threatening Macular Edema

描述(由申请人提供)：i建议的SBIR计划的总体目标是实施和评估一种低成本的便携式视网膜相机-数字光眼底镜(DLO)，具有光学相干断层扫描(OCT)提供的视网膜厚度测量功能。组合的DLO-OCT系统将以经济高效的方式识别患有威胁视力的黄斑水肿的患者，以便转诊和治疗。未经治疗的黄斑水肿导致的视力丧失已达到流行水平，是多种疾病的结果，包括糖尿病和其他视网膜血管疾病、炎症性疾病、视网膜牵引和白内障手术的并发症。为了充分解决这个问题，从社区诊所到眼科检查通道的筛查工具必须包括定量视网膜厚度测量，以无缝地引导患者进行挽救视力的治疗。为了应对日益增长的眼部护理成本和差距，永旺成像提出了一种新型的视网膜成像设备，DLO。永旺的DLO是视网膜相机的独特之处，它使用数字投影仪进行照明，并使用CMOS滚动快门检测来提供高对比度、共焦的视网膜视图。操作员可以使用红色或绿色照明以实时帧速率对视网膜成像，而不会放大瞳孔。DLO是微处理器控制的，通过软件进行光学对准，支持互联网，紧凑而轻便，使其易于从标准裂隙灯式对准底座上拆卸，便于运输。目标价位远低于竞争产品，这些产品使用昂贵的扫描元件和激光照明源，需要耗时的光学对准。永旺的DLO已经在印第安纳大学和加利福尼亚州阿拉米达县的伊斯特蒙特健康中心社区诊所建造并进行了现场测试。这家社区诊所为服务不足、主要是少数族裔的患者提供县级保险的眼科护理。在测试期间，OCT可以清楚地显示糖尿病黄斑水肿(DME)，但通常用于筛查的单镜眼底相机图像可能会遗漏DME。如果诊断及时，DME是可以治疗的，因此永旺建议将新的具有成本效益的OCT技术集成到DLO中，使用数字投影仪和CMOS滚动快门传感器来进行黄斑厚度测量。在第一阶段，永旺建议开发和测试其DLO-OCT设备的视网膜厚度测量精度，使用海德堡光谱SLO/OCT测量作为金标准。如果DLO的新视网膜厚度测量技术成功，拟议的DLO-OCT设备将提供准确检测需要紧急转诊的患者视力威胁黄斑水肿的手段，成本只有DLO-OCT的一小部分。通过降低OCT技术的成本，它将在筛查和眼科护理环境中得到更广泛的应用，有助于更准确地检测可治疗的视力丧失的早期迹象。

DESCRIPTION (provided by applicant): I The overall goal of the proposed SBIR program is to implement and evaluate a low cost, portable retinal camera, the Digital Light Ophthalmoscope (DLO), with retinal thickness measurement functionality provided by optical coherence tomography (OCT). The combined DLO-OCT system will cost-effectively identify patients with vision-threatening macular edema for referral and treatment. Vision loss due to untreated macular edema has reached epidemic levels and is the result of a wide variety of conditions, including diabetes and other retinal vascular diseases, inflammatory diseases, retinal traction, and complications of cataract surgery. To fully address this issue, screening tools from the community clinic to the ophthalmic exam lane must include quantitative retinal thickness measurements to seamlessly lead patients to vision-saving treatment. In response to the ever-growing costs and disparities in eye care, Aeon Imaging has proposed a novel retinal imaging device, the DLO. Unique to retinal cameras, Aeon's DLO uses a digital light projector for illumination and CMOS rolling shutter detection to provide high contrast, confocal views of the retina. Operators can image the retina at real-time frame rates using either red or green illumination without pupillary dilation. The DLO is microprocessor controlled, optically aligned through software, internet ready, and is compact and lightweight, making it easily detachable from a standard slit-lamp style alignment base for ease of transport. The target price point is well below competing products that use expensive scanning elements and laser illumination sources, and require time-consuming optical alignment. Aeon's DLO has been built and field tested at both Indiana University and at the Eastmont Wellness Center community clinic in Alameda County, CA. This community clinic provides county-insured eye care to underserved, mainly minority patients. During testing, diabetic macular edema (DME) was clearly indicated using OCT, but could be missed on the monoscopic fundus camera images commonly used for screening. DME is treatable if diagnosed in a timely manner, and therefore Aeon proposes to integrate novel cost- effective OCT technology, using a digital light projector and CMOS rolling shutter sensor, into the DLO to perform macular thickness measurements. In Phase I, Aeon proposes to develop and test the retinal thickness measurement accuracy of its DLO- OCT device, using Heidelberg Spectralis SLO/OCT measurements as the gold standard. If the DLO's new retinal thickness measurement technology is successful, the proposed DLO-OCT device will provide the means to accurately detect sight-threatening macular edema in patients requiring urgent referrals at a fraction of the cost. By reducing the cost of OCT technology, it wil be more widely used in both screening and ophthalmic care settings, helping to more accurately detect early signs of treatable vision loss.