Compact Adaptive Optics Clinical Prototype for Retinal Imaging

描述（由申请人提供）：Physical Sciences Inc. (PSI)正在完成一个第二阶段的计划，展示了一个紧凑的研究仪器，集成自适应光学（AO）到线扫描检眼镜（LSO）。台式AO-LSO仪器显著降低了研究型AO扫描激光检眼镜（AOSLO）的尺寸、复杂性和成本，目标是将自适应光学成像转变为常规临床使用。PSI AO-LSO仅使用一个移动部件即可生成高分辨率视网膜图像，并显著减少了仪器占用空间和光学元件数量。AO-LSO具有中等视野（3.5x5度），可快速有效地获得黄斑或其他目标的蒙太奇。OCT通道也用作AO信标。在初步的人类受试者研究中，光感受器被分辨并计数到中央凹的约0.5度内。光感受器计数与先前报道的组织学密切匹配。中央凹无血管区周围的毛细血管清晰可见，包括其中流动的血细胞。单个神经纤维束被解析，特别是在视神经头附近，以及其他结构，如筛板。除了仪器设计、制造和测试之外，还开发了用于自动图像配准、锥体计数和蒙太奇拼接的软件算法。 阶段II B计划的目标是技术成熟。PSI建议继续临床原型的早期产品开发，以提高性能，开发新型患者界面，改进软件用户界面，开发自动化图像分析程序，并产生兴趣和私人投资，将技术推向市场。这一努力的成功将大大提高FDA早期监管批准的可能性。我们的总体目标是以显著降低的成本将紧凑型AO系统商业化，以弥合高分辨率实验室系统和传统临床SLO/OCT成像模式之间的现有差距。AO-LSO仪器将针对临床操作进行改进和增强，包括优化重新设计光学布局以实现更小的占地面积、临床包的光学机械设计、修改扫描硬件和软件以自动获取改进的黄斑蒙太奇和感光密度图。将升级几个组件和子系统，以提高性能和临床适应性，包括瞳孔跟踪和作为图像质量指标的在线点扩散函数（PSF）监测。成功的II期B项目和随后的III期商业开发将为临床医生提供高分辨率、高性能的AO成像，其成本更低，功能上级优于其他非AO视网膜成像仪，有助于指导治疗并改善患者预后。

DESCRIPTION (provided by applicant): Physical Sciences Inc. (PSI) is completing a Phase II program demonstrating a compact research instrument that integrates adaptive optics (AO) into a line scanning ophthalmoscope (LSO). The bench-top AO-LSO instrument significantly reduces the size, complexity, and cost of research AO scanning laser ophthalmoscopes (AOSLO), with the goal of transitioning adaptive optics imaging into routine clinical use. The PSI AO-LSO produces high resolution retinal images with only one moving part and a significantly reduced instrument footprint and number of optical components. The AO-LSO has a moderate field of view (3.5x5 deg), which allows montages of the macula or other targets to be quickly and efficiently obtained. An OCT channel also serves as the AO beacon. In a preliminary human subjects investigation, photoreceptors were resolved and counted to within ~0.5 deg of the fovea. Photoreceptor counts closely matched previously reported histology. The capillaries surrounding the foveal avascular zone were well-resolved, including the blood cells flowing within them. Individual nerve fiber bundles were resolved, especially near the optic nerve head, as well as other structures such as the lamina cribrosa. In addition to instrument design, fabrication, and testing, software algorithms were developed for automated image registration, cone counting, and montage stitching. The goal of a Phase II B program is technology maturation. PSI proposes to continue early stage product development of the clinical prototype to improve performance, develop a novel patient interface, improve the software user interface, develop automated image analysis routines, and generate interest and private investment to bring the technology to the market. Success in this effort will greatly enhance the likelihood of early FDA regulatory approval. Our overall goal is to commercialize a compact AO system at significantly lower cost that bridges the existing gap between high-resolution laboratory systems and conventional clinical SLO/OCT imaging modalities. The AO-LSO instrument will be refined and enhanced for clinical operation, including an optimized re-design of the optical layout for a smaller footprint, opto- mechanical design of a clinical package, modification of scanning hardware and software for automatically acquiring improved macular montages and photoreceptor density maps. Several components and subsystems will be upgraded for improved performance and clinical adaptability, including pupil tracking and on-line point spread function (PSF) monitoring as an image quality metric. A successful Phase II B program and subsequent Phase III commercial development will provide clinicians with high-resolution, high performance AO imaging at a lower cost and improved functionality superior to other non-AO retinal imagers to help guide therapies and improve patient outcome.