Intrasurgical Optical Coherence Tomography

术中光学相干断层扫描

基本信息

批准号：
8782159
负责人：
Eric L. Buckland
金额：
$ 22.5万
依托单位：
BIOPTIGEN, INC.
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-30 至 2015-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8782159
关键词：
Algorithms Animals Anterior Automobile Driving Cataract Cataract Extraction Clinic Clinical Clinical Research Collaborations Complement Computer software Decision Making Development Diabetic Retinopathy Disease Electronics Environment Evaluation Eye FDA approved Feedback Hand Healthcare Human Image Image Analysis Imagery Imaging technology Industry Institutes Laboratories Left Marketing Membrane Microscope Modeling Nature Operating Rooms Operative Surgical Procedures Optical Coherence Tomography Optics Outcome Patients Performance Phase Postoperative Period Preparation Procedures Quality of Care Resolution Retinal Retinal Detachment Risk Simulate Speed Structure Surgeon System Technology Testing Time Tissues Training Trauma Ultrasonography Visualization software Vitrectomy arm base commercialization cost design disorder of macula of retina ergonomics evaluation/testing flexibility imaging modality improved innovation intraoperative imaging operation optical imaging public health relevance research study tool

项目摘要

DESCRIPTION (provided by applicant): Each year, over 20 million ophthalmic surgeries are performed worldwide. Indications for ophthalmic surgery include potentially blinding diseases, such as cataracts, diabetic retinopathy, macular disease, and retinal detachment. Surgeons performing these delicate procedures are challenged by the translucent nature of tissues in the eye, making it nearly impossible to visualize microstructural changes during surgery. Optical coherence tomography (OCT) is a non-contact, optical imaging modality that provides high-resolution cross-sectional images of the various layers of the anterior and posterior eye. OCT is also commonly used to aid in ophthalmic surgical planning and post-operative assessment, and more recently, has been used perioperatively. Intraoperative OCT offers the surgeon the ability to see the microstructure of the eye in a way not possible with conventional surgical microscopes. By improving tissue visualization and providing surgical feedback, intraoperative OCT will enhance surgical precision, decrease surgical trauma, aid in surgical decision-making and ultimately improve functional and anatomical outcomes. Bioptigen is at the forefront of intrasurgical OCT imaging technology, with the only OCT system on the market with an FDA approved indication for intrasurgical imaging. Currently, intrasurgical imaging is performed using a hand-held probe, or by mounting such a probe to the surgical microscope. In this proposal, we describe the development of an intraoperative OCT system integrated directly into the optical train of the surgical microscope. In Phase I, we will complete development of the SMI and integrate it with our OCT engine technology. We will also verify the optical performance of the SMI. In Phase II, Bioptigen will focus on the development of surgery-specific software. Initial testing and evaluation of the intraoperative OCT system will also be performed in Phase II, in collaboration with the Cole Eye Institute at the Cleveland Clinic. This initial testing will includ laboratory feasibility testing, quality assessment, and ergonomic evaluation. Following initial testing, our collaborators will perform simulated surgical procedures with intraoperative OCT. Feedback from these initial tests and simulated surgeries will be used to iterate on system design in preparation for human clinical studies. Ultimately, the commercialization of intraoperative OCT technology will bring state-of-the-art OCT imaging technology to the surgical bedside, improving the quality of care for millions of patients each year.

描述（由申请人提供）：全世界每年进行超过 2000 万例眼科手术。眼科手术的适应症包括潜在致盲的疾病，例如白内障、糖尿病性视网膜病变、黄斑疾病和视网膜脱离。执行这些精细手术的外科医生面临着眼睛组织半透明特性的挑战，使得手术期间几乎不可能看到微观结构的变化。光学相干断层扫描 (OCT) 是一种非接触式光学成像方式，可提供前眼和后眼各层的高分辨率横截面图像。 OCT 也常用于辅助眼科手术计划和术后评估，最近还用于围手术期。术中 OCT 使外科医生能够以传统手术显微镜无法实现的方式观察眼睛的微观结构。通过改善组织可视化和提供手术反馈，术中 OCT 将提高手术精度、减少手术创伤、帮助手术决策并最终改善功能和解剖结果。 Bioptigen 处于手术内 OCT 成像技术的前沿，拥有市场上唯一获得 FDA 批准的手术内成像适应症的 OCT 系统。目前，手术内成像是使用手持式探头或通过将此类探头安装到手术显微镜来进行的。在本提案中，我们描述了直接集成到手术显微镜光学系统中的术中 OCT 系统的开发。在第一阶段，我们将完成SMI的开发并将其与我们的OCT引擎技术集成。我们还将验证SMI的光学性能。在第二阶段，Bioptigen 将专注于手术专用软件的开发。术中 OCT 系统的初步测试和评估也将在第二阶段与克利夫兰诊所的科尔眼科研究所合作进行。初步测试将包括实验室可行性测试、质量评估和人体工程学评估。初步测试后，我们的合作者将使用术中 OCT 进行模拟外科手术。这些初始测试和模拟手术的反馈将用于迭代系统设计，为人体临床研究做准备。最终，术中 OCT 技术的商业化将为手术床边带来最先进的 OCT 成像技术，从而提高每年数百万患者的护理质量。