Visible-light optical coherence tomography for clinical glaucoma management

可见光光学相干断层扫描用于临床青光眼治疗

• 批准号: 10484749
• 负责人: Roman Kuranov
• 金额: $ 70.59万
• 依托单位: OPTICENT, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10484749
• 关键词: Address; Adoption; Algorithms; Anatomy; Angiography; Area; Back; Biological Markers; Blood Vessels; Caring; Cells; Clinical; Clinical Management; Clinical Research; Color; Data; Dendrites; Detection; Diagnosis; Disease; Doppler Ultrasound; Error Sources; Eye; Floor; Functional Imaging; Glaucoma; Goals; Hemoglobin; Hospitals; Human; Image; Imaging technology; Inner Plexiform Layer; Lasers; Legal patent; Measurement; Measures; Mechanics; Metabolic; Metabolism; Methodology; New York; Noise; Ophthalmology; Ophthalmoscopes; Optical Coherence Tomography; Optics; Oxygen; Pathogenesis; Pathway interactions; Patients; Phase; Plant Roots; Positioning Attribute; Protocols documentation; Pupil; Reproducibility; Research; Research Personnel; Resolution; Retina; Retinal Ganglion Cells; Sampling; Scanning; Scientist; Small Business Innovation Research Grant; Source; Speed; Structure; Synapses; System; Techniques; Technology; Testing; Thick; Time; Tissues; Ultrafine; Universities; Validation; Variant; Virginia; Visible Radiation; Work; arteriole; base; clinical imaging; clinical research site; clinically translatable; computerized data processing; design; early detection biomarkers; healthy volunteer; imaging capabilities; improved; metabolic imaging; multidisciplinary; neurotoxic; next generation; relating to nervous system; research clinical testing; retinal imaging; sample fixation; stereoscopic; system architecture; technology development; theories; tool; ultra high resolution; venule

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.

项目概要 该 SBIR IIB 期项目侧重于开发、表征和验证下一代临床 可见光光学相干断层扫描（vis-OCT）作为改善临床管理的临床工具 Opticent, Inc. 的新型 vis-OCT (Aurora X3) 将以 A 线速率提供 1.3 µm 轴向分辨率。 高达 250 kHz 的新 Aurora X3 系统体现了新设计的红色激光扫描内眼固定。 以及完全集成的近红外扫描激光眼科，具有全新的平衡检测视觉系统 OCT 首次实现散粒噪声限制成像 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红蛋白氧饱和度 (sO2)。 青光眼的结构变化被认为是内层视网膜神经节细胞（RGC）树突的收缩。 丛状层 (IPL) 通过散射减少或 IPL 变化来识别突触损失。 子层的厚度，可以作为比任何其他青光眼更早、更敏感的生物标志物 测量视网膜 sO2 和特定小动脉-小静脉对可以确定氧含量。 在这些船只所服务的地区进行提取，我们的初步数据表明，出现损坏的地区 青光眼眼睛中的氧气提取量低于健康眼睛中类似区域的氧气提取量。 表明这种吸氧异常可以远远超出“地板效应”阈值进行测量 通过传统 OCT 进行记录，可以在传统结构无法预测的时间点之外对疾病进行评估 OCT变得不敏感。该项目将使用最新的Aurora X3临床进行多部位临床测试。 纽约大学、斯坦福大学和弗吉尼亚大学的 vis-OCT 验证了拟议的 IPL 和 青光眼中的 sO2 生物标志物。