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.

项目摘要 这个SBIR阶段IIB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）作为改善临床管理的临床工具 青光眼。 Optipent，Inc。的新型Vis-OCT（Aurora X3）将以A线速率提供1.3 µm轴向分辨率 最多250 kHz。新的Aurora X3系统体现了新设计的红色激光扫描内部眼睛固定 以及完全集成的近红外扫描激光眼科，主要是新的平衡检测 OCT，第一次接近射击量限制成像。 Aurora X3的改编将解决两个 未满足的临床青光眼诊断和进展检测的需求：（1）测量残余的能力 子层结构和（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缩回的视网膜神经节细胞（RGC）树突 丛状层（IPL）。通过下降或通过IPL的变化来确定突触的丧失 子层的厚度可能比其他任何人都可以作为青光眼更早，更灵敏的生物标志物 临床标准。测量视网膜SO2和特定的小动脉 - 弯曲夫妇可以确定氧气 这些船只服务的地区提取，我们的初步数据表明区域显示损坏 在青光眼中，与健康眼睛中的类似区域相比，眼睛的提取量低。这个观察结果 表明可以远远超出“地板效应”阈值，可以远远测量这种氧气提取异常 用常规的OCT注意，允许评估疾病超出常规结构的时间点 OCT变得不敏感。该项目将使用最新的Aurora X3临床进行多站点的临床测试 纽约大学，斯坦福大学和弗吉尼亚大学的VIS-OCT验证拟议的IPL和 青光眼中的SO2生物标志物。