Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance

用于眼科手术指导的术中光学相干断层扫描

• 批准号: 9803346
• 负责人: Yuankai Kenny Tao
• 金额: $ 37.77万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9803346
• 关键词: 4D Imaging; Adoption; Adult; Affect; Age related macular degeneration; American; Biomechanics; Blindness; Blood Vessels; Cannulations; Cataract; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; Complex; Computer software; Consumption; Corneal dystrophy; Data; Data Storage and Retrieval; Decision Making; Development; Diabetic Retinopathy; Diagnostic; Engineering; Eye; FDA approved; Feedback; Financial compensation; Foundations; Frequencies; Future; Generations; Genes; Glaucoma; Goals; Gold; Head; Image; Image-Guided Surgery; Imagery; Incidence; Keratoplasty; Lead; Lighting; Membrane; Methods; Microscope; Microscopy; Operative Surgical Procedures; Ophthalmology; Optical Coherence Tomography; Outcome; Performance; Population; Positioning Attribute; Postoperative Period; Prevalence; Procedures; Proliferative Vitreoretinopathy; Protocols documentation; Retinal; Safety; Sampling; Scanning; Speed; Structure; Surgical Specialties; Surgical sutures; Technology; Therapeutic; Time; Tissue imaging; Tissues; United States; Visual impairment; Vitrectomy; aging population; base; bulk motion; clinical Diagnosis; cost; density; fly; follow-up; functional outcomes; image guided; image registration; imaging Segmentation; imaging study; improved; improved outcome; in vivo; in vivo imaging; instrument; interest; multidisciplinary; multimodality; new technology; next generation; novel; programs; real-time images; robot assistance; simulation; standard of care; stem cell therapy; subretinal injection; success; surgery outcome; technology development; tomography

The leading causes of low vision and blindness, which include cataract, glaucoma, age-related macular degeneration, corneal dystrophy, and diabetic retinopathy, affect over 40 million Americans and have an estimated annual cost of $25 billion for clinical diagnosis and treatment. The prevalence of visual impairment in adults 40 years and older in the United States is above 3.5% and expected to increase markedly due to population aging. Although several recent studies have demonstrated the utility of intraoperative OCT (iOCT) for verifying completion of surgical goals, real-time iOCT feedback is not currently used to guide ophthalmic surgery because of several fundamental limitations of current-generation iOCT technology: (1) Serial cross-sectional OCT does not provide sufficient spatial position and orientation feedback to guide surgery. (2) Video-rate volumetric OCT trades-off sampling density with field-of-view and consistent alignment of small static OCT fields to regions-of-interest is prohibitively difficult during surgical maneuvers. (3) Co-registration of volumetric OCT data with the surgical field is challenging because fiducials are often confounded by the non-uniform illumination and contrast of surgical microscopy. (4) Real-time volumetric OCT visualization is complex and time-consuming, requiring cross-sectional fly-throughs or computationally expensive renderings that occlude subsurface features. We recently developed multimodal intraoperative spectrally encoded coherence tomography and reflectometry (iSECTR) technologies that allows for simultaneous and intrinsically co-registered en face reflectance and cross- sectional OCT imaging. We hypothesize that (1) imaging data from 4D iSECTR of surgical dynamics will benefit surgical decision-making and lead to improved functional outcomes; and (2) integration of imaging, registration, segmentation, and feedback using heads-up display (HUD) visualization will enhance existing and enable novel surgical maneuvers. We have assembled a multidisciplinary team of engineers and clinicians to perform foundational ex vivo and in vivo imaging studies to (1) quantitatively assess the safety and utility of 4D iSECTR- based surgical feedback; and (2) develop novel technologies, feedback mechanisms, and maneuvers that integrate volumetric iSECTR data for image-guided ophthalmic surgery. Comprehensive 4D imaging of tissue- instrument interaction dynamics (AIM 1) provides unprecedent data on structural changes resulting from surgical manipulation that may be predictive of post-operative functional outcomes and enable image-based interrogation of biomechanics and personalized surgical planning. Real-time surgical visualization and guidance (AIM 2) may improve success rates of conventional surgical interventions as well as next-generation gene and stem cell therapies. Image-guided surgery also may be compatible with robotic-assistance and telemanipulation in wide- ranging surgical specialties outside of ophthalmology. Quantitative analysis of intraoperative imaging performance, utility, and clinical value (AIM 3) will motivate future technology development and clinical adoption.

低视力和失明的主要原因包括白内障、青光眼、年龄相关性黄斑变性、视网膜病变和视网膜病变。 角膜变性、角膜营养不良和糖尿病性视网膜病变影响着超过4000万美国人， 估计每年用于临床诊断和治疗的费用为250亿美元。视力损害的患病率 美国40岁及以上的成年人超过3.5%，预计将显著增加， 人口老龄化尽管最近的几项研究已经证明了术中OCT（iOCT）对于 验证手术目标的完成，实时iOCT反馈目前未用于指导眼科手术 由于当前一代iOCT技术的几个基本限制：（1）连续横截面 OCT不能提供足够的空间位置和方向反馈来指导手术。(2)视频速率 体积OCT权衡采样密度与视场和小静态OCT场的一致对准 在外科手术操作过程中非常困难。(3)体积OCT的配准 手术野的数据是具有挑战性的，因为基准点经常被不均匀的照明混淆， 和手术显微镜的对比度。(4)实时体积OCT可视化是复杂且耗时的， 这需要遮挡地下特征的横截面飞行模拟或计算上昂贵的绘制。 我们最近开发了多模式术中光谱编码相干断层扫描和反射仪 （iSECTR）技术，该技术允许同时且内在地共配准正面反射和交叉反射， 断层OCT成像。我们假设（1）手术动力学的4D iSECTR成像数据将受益于 手术决策并导致改善功能结果;以及（2）成像、配准 分割和使用平视显示器（HUD）可视化的反馈将增强现有的，并使新的 手术操作我们组建了一支由工程师和临床医生组成的多学科团队， 基础性离体和体内成像研究，以（1）定量评估4D iSECTR的安全性和实用性- 基于手术反馈;（2）开发新技术、反馈机制和操作， 用于图像引导眼科手术集成体积iSECTR数据。组织的全面4D成像- 器械相互作用动力学（AIM 1）提供了关于手术引起的结构变化的前所未有的数据 可以预测术后功能结果并实现基于图像的询问的操作 生物力学和个性化的手术计划。实时手术可视化和引导（AIM 2）可以 提高传统外科手术以及下一代基因和干细胞治疗成功率 治疗图像引导手术也可以与机器人辅助和远程操纵兼容， 包括眼科以外的外科专业。术中影像学定量分析 性能、实用性和临床价值（AIM 3）将推动未来的技术开发和临床采用。