Adaptive Retina-Tracking Optical Coherence Tomography System

描述（由申请人提供）：众所周知，如果视网膜病变，特别是糖尿病视网膜病变没有通过医疗干预“及时”检测和控制，它们可能进展为增殖性视网膜病变，并导致视力显著下降和失明。据估计，在2008年，美国约有2400万人[1]，全世界约有1.94亿人患有糖尿病（根据卡尔加里大学，2009年3月17日）。根据世界卫生组织的数据，目前糖尿病视网膜病变占世界失明人数的5%[2]。 早期发现糖尿病视网膜病变对于避免永久性眼损伤和视力损害至关重要。 为了促进视网膜病变的早期检测和诊断，物理光学公司（POC）提出开发一种新的高速自适应视网膜跟踪光学相干断层扫描（ART-OCT）系统，该系统基于谱域光学相干断层扫描（SDOCT），独特地结合了高速自适应视网膜跟踪和像差补偿。该系统集成了铁电液晶（FLC）快速扫描光学延迟（RSOD）线，高分辨率的自适应光学像差校正的微机电（MEMS）变形镜，夏克哈特曼波前传感器，和快速视网膜跟踪的光电联合傅里叶变换相关的装置。新颖的ART-OCT设计将产生用于视网膜的快速非侵入性原位和体内断层摄影成像的稳健、紧凑且易于使用的系统，其具有高对比度和高3D分辨率（即，横向分辨率为2.5 μ m，轴向分辨率<5.5 μ m），以及图像稳定和增强，其可潜在地用于诸如视网膜微动脉瘤、视网膜水肿、硬性渗出物等异常的形态鉴别和分析。因此，ART-OCT能够及时/早期检测激光光凝治疗的威胁视力的视网膜病变，从而避免后续严重视觉损伤和永久性视觉障碍的风险。在第一阶段，POC将确定集成ART-OCT系统的物理和性能规格，例如横向和轴向分辨率、灵敏度以及成像和跟踪速度。将通过设计、制造和测试台式ART-OCT原型来证明ART-OCT技术的可行性。此外，鉴于与UCLA在类似项目上的现有合作，POC起草了类似的IRB程序，用于在II期实施的初步临床试验。POC计划在第二阶段开发全面运行的ART-OCT原型，并展示其在糖尿病视网膜病变显微血管3D成像方面的能力。该项目的成功完成将为视网膜微动脉瘤和直径为10至100微米的其他异常的原位和体内早期诊断提供解决方案。与视网膜病变水平为35及以上的现有解决方案相比，这种增强的精度转换为基于视网膜病变水平的2 - 1 -35及以下的早期水平（见表2-1）。 公共卫生相关性：ART-OCT提供高速眼睛跟踪、深度视网膜快速扫描和图像增强能力，克服了当前（衍射受限）眼科视网膜成像系统由于光学失真、眼睛像差和眼睛运动引起的空间分辨率自然损失而造成的限制。因此，所提出的系统提供了与单个细胞的大小相当的高3D分辨率，因此将代表用于早期诊断和监测糖尿病视网膜病变和视网膜和脉络膜的其他血管疾病的高效、非接触、准确和非侵入性技术的突破。

DESCRIPTION (provided by applicant): It is widely know that if retinopathy and specifically diabetic retinopathy are not "duly" detected and controlled through medical interventions, they can progress into a proliferative retinopathy and cause significant decrease in visual acuity and blindness. It is estimated that in 2008, approximately 24 million in the U.S. [1] and 194 million people worldwide suffered from diabetes (according to University of Calgary, March 17, 2009,). Nowadays, diabetic retinopathy accounts for 5% of the world's blindness, according to the World Health Organization [2]. Early detection of diabetic retinopathy is essential to averting permanent ocular damage and visual impairment. To facilitate early detection and diagnosis of retinopathy, Physical Optics Corporation (POC) proposes to develop a new high-speed Adaptive Retina-tracking Optical Coherence Tomography (ART-OCT) system based on spectral domain optical coherence tomography (SDOCT) uniquely combined with high-speed adaptive retina tracking and aberration compensation. The system integrates a ferroelectric liquid crystal (FLC) rapid-scanning optical delay (RSOD) line, with high-resolution adaptive optics aberration correction by means of a microelectromechanical (MEMS) deformable mirror, a Shack-Hartmann wavefront sensor, and fast retina tracking by means of optoelectronic joint Fourier transform correlation. The novel ART-OCT design will produce a robust, compact, and simple-to-use system for fast noninvasive in-situ and in-vivo tomographic imaging of the retina with high contrast and high 3D resolution (i.e., transverse resolution of 2 5m and an axial resolution of <5 5m), as well as image stabilization and enhancement which can be potentially used in morphological discrimination and analysis of abnormalities such as retinal microaneurysms, retinal edema, hard exudates. As a result, ART-OCT enables timely/early detection of sight- threatening retinopathy for laser photocoagulation and thus it avoids the risks of subsequent severe visual lesion and permanent visual impairness. In Phase I, POC will determine the physical and performance specifications of the integrated ART-OCT system, such as transverse and axial resolution, sensitivity, and imaging and tracking speed. Feasibility of the ART-OCT technology will be demonstrated by designing, fabricating, and testing a bench-top ART-OCT prototype. In addition, given the existing collaboration with UCLA on similar projects, POC drafts similar IRB procedures for preliminary clinical tests to be implemented in Phase II. POC plans to develop a fully operational ART-OCT prototype in Phase II and demonstrate its capabilities in 3D imaging of microscopic blood vessels in diabetic retinopathy. Successful completion of the project will lead to a solution for in-situ and in-vivo early-stage diagnosis of retinal microaneurysms and other abnormalities with diameters of 10 to 100 microns. This enhanced precision translates to early-stage levels of 21-35 and below based on Retinopathy Levels, compared with the existing solutions with retinopathy levels of 35 and above (see Table 2-1). PUBLIC HEALTH RELEVANCE: The ART-OCT provides high-speed eye tracking, in-depth retina rapid-scanning and image enhancement capabilities that overcome the limitation of current (diffraction-limited) ophthalmological retina imaging systems due to natural loss of spatial resolution caused by the optical distortions, eye aberrations, and eye movement. Therefore, the proposed system provides a high 3D resolution comparable to the size of individual cells and hence will represent a breakthrough in efficient, noncontact, accurate, and noninvasive techniques for early diagnosis and monitoring of diabetic retinopathy and other vascular diseases of the retina and choroids.