Visible-light optical coherence tomography for clinical glaucoma management

项目摘要 该SBIR阶段IIB项目专注于开发、表征和验证下一代临床 可见光光学相干断层扫描(VIS-OCT)作为一种改善临床管理的临床工具 青光眼。Opticent，Inc.的新款VIS-OCT(Aurora X3)将提供1.3微米的轴向分辨率，A线速率为 最高可达250千赫。新的Aurora X3系统体现了新设计的红色激光扫描内固定眼 和一个完全集成的近红外扫描激光眼科，主要是一个新的平衡检测相对于- OCT，这是第一次接近散粒噪声限制成像。Aurora X3的采用将解决两个问题 临床青光眼诊断和进展检测中未满足的需求：(1)测量视网膜的能力 (2)准确评估局部视网膜血氧饱和度(SO2)。最早的 青光眼的结构变化被认为是视网膜神经节细胞(RGC)内树突的回缩 网状层(IPL)。识别突触丢失，无论是通过散射减少还是通过IPL的变化 下层厚度可作为青光眼的早期和更敏感的生物标志物。 临床标准。测量视网膜SO2和特定的小动脉-小静脉偶联可以确定氧气 在这些船只服务的区域进行提取，我们的初步数据表明，显示损坏的区域 青光眼患者的氧摄取量低于健康眼的类似区域。这一观察结果 这表明这种氧摄取异常可以被测量到远远超出“地板效应”的阈值。 与传统OCT一起记录，允许在传统结构的时间点之外评估疾病 OCT变得麻木不仁。该项目将使用最新的Aurora X3临床设备进行多点临床测试 纽约大学、斯坦福大学和弗吉尼亚大学的VIS-OCT，以验证拟议的IPL和 青光眼中的SO2生物标志物。

Project Summary This SBIR Phase IIB project focuses on developing, characterizing, and validating the next-generation clinical visible-light optical coherence tomography (vis-OCT) as a clinical tool to improve the clinical management of glaucoma. The new vis-OCT (Aurora X3) by Opticent, Inc. will offer 1.3-µm axial resolution at an A-line rate of up to 250 kHz. The new Aurora X3 system embodies a newly-designed red laser scanning internal eye fixation and a fully integrated near-infrared scanning laser ophthalmology with a principally new balanced-detection vis- OCT, which approaches shot-noise limited imaging for the first time. The adoption of Aurora X3 will address two unmet needs in clinical glaucoma diagnosis and detection of progression: (1) the ability to measure retinal sublayer structure and (2) to accurately assess local retinal hemoglobin oxygen saturation (sO2). The earliest structural changes in glaucoma are thought to be retracting retinal ganglion cell (RGC) dendrites in the inner plexiform layer (IPL). Identifying loss of synapses, either by decreased scattering or by the change in IPL sublayers’ thicknesses, could serve as an earlier and more sensitive biomarker for glaucoma than any other clinical standard. Measuring retinal sO2 and specific arteriole-venule couplets can determine the oxygen extraction in the regions served by those vessels, and our preliminary data indicate that regions showing damage in glaucomatous eyes have lower oxygen extraction than similar areas in healthy eyes. This observation suggests that such oxygen extraction abnormalities can be measured well beyond the “floor effect” threshold noted with conventional OCT, allowing assessment of disease beyond the time point that conventional structural OCT becomes insensitive. This project will conduct a multi-site clinical test using the latest Aurora X3 clinical vis-OCT at New York University, Stanford University, and University of Virginia to validate the proposed IPL and sO2 biomarkers in glaucoma.