Visible-light optical coherence tomography for clinical glaucoma management

项目摘要 该SBIR IIB期项目的重点是开发、表征和验证下一代临床 可见光光学相干断层扫描（vis-OCT）作为一种临床工具，以改善临床管理 青光眼Opticent，Inc.的新型vis-OCT（Aurora X3）将提供1.3微米的轴向分辨率，A线速率为 高达250 kHz。新的Aurora X3系统体现了新设计的红色激光扫描内眼固定 和一个完全集成的近红外扫描激光眼科与一个主要的新的平衡检测维斯光， OCT首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）测量视网膜病变的能力， 亚层结构和（2）准确评估局部视网膜血红蛋白氧饱和度（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）树突在内部收缩， 网状层（IPL）。通过散射减少或IPL变化识别突触丢失 亚层的厚度，可以作为一个更早，更敏感的生物标志物青光眼比任何其他 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 在这些船只服务的地区进行开采，我们的初步数据表明， 与健康眼睛中的类似区域相比，青光眼眼睛中的氧提取较低。该观察结果 表明这种氧提取异常可以在“地板效应”阈值之外进行测量 用传统的OCT注意到，允许在传统的结构性检查的时间点之外评估疾病。 OCT变得不敏感。该项目将使用最新的Aurora X3临床 vis-OCT在纽约大学、斯坦福大学和弗吉尼亚大学验证拟议的IPL， 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.