Intrasurgical Optical Coherence Tomography

描述（由申请人提供）：每年，全世界进行超过2000万例眼科手术。眼科手术的适应症包括潜在的致盲疾病，如白内障、糖尿病视网膜病变、黄斑疾病和视网膜脱离。进行这些精细手术的外科医生受到眼睛组织半透明性质的挑战，这使得在手术过程中几乎不可能看到显微结构的变化。 光学相干断层扫描（OCT）是一种非接触式光学成像模式，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，最近已用于围手术期。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看到眼睛的微观结构。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，辅助手术决策，并最终改善功能和解剖结局。 Bioptigen处于术中OCT成像技术的最前沿，是市场上唯一一款获得FDA批准的术中OCT系统。目前，手术内成像是使用手持式探头或通过将这种探头安装到手术显微镜来执行的。在该提案中，我们描述了直接集成到手术显微镜的光学系统中的术中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引擎技术相结合。我们还将验证SMI的光学性能。在第二阶段，Bioptigen将专注于开发手术专用软件。术中OCT系统的初始测试和评价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。初始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。在初始测试之后，我们的合作者将使用术中OCT进行模拟手术。这些初始测试和模拟手术的反馈将用于验证系统设计，为人体临床研究做准备。最终，术中OCT技术的商业化将把最先进的OCT成像技术带到手术床边，每年为数百万患者提高护理质量。

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.