Compact Adaptive Optics Clinical Prototype for Retinal Imaging

描述(由申请人提供)：物理科学公司(PSI)正在完成一项第二阶段计划，该计划展示了一种将自适应光学(AO)集成到线扫描检眼镜(LSO)中的紧凑型研究仪器。台式AO-LSO仪器显著降低了研究AO扫描激光眼底镜(AOSLO)的尺寸、复杂性和成本，目标是将自适应光学成像过渡到常规临床使用。PSI AO-LSO产生只有一个活动部件的高分辨率视网膜图像，并且显著减少了仪器占地面积和光学组件数量。AO-LSO的视场适中(3.5x5°)，可以快速有效地获得斑点或其他目标的蒙太奇图像。OCT通道也充当了声光信标。在一项初步的人体受试者调查中，光感受器被分解并计数到中心凹约0.5度以内。光感受器计数与先前报道的组织学结果非常接近。中心凹无血管区周围的毛细血管溶解良好，包括其中流动的血细胞。个别神经纤维束被分解，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、圆锥体计数和蒙太奇拼接的软件算法。第二阶段B计划的目标是技术成熟。PSI建议继续进行临床原型的早期产品开发以提高性能，开发新的患者界面，改进软件用户界面，开发自动图像分析例程，并产生兴趣和私人投资，将技术推向市场。这一努力的成功将极大地提高FDA及早获得监管批准的可能性。我们的总体目标是以显著较低的成本将紧凑型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仪器将进行改进和增强，以用于临床操作，包括优化重新设计光学布局以减少占地面积，临床包的光机械设计，修改扫描硬件和软件以自动获取改进的黄斑蒙太奇和光感受器密度图。几个组件和子系统将进行升级，以提高性能和临床适应性，包括作为图像质量衡量标准的瞳孔跟踪和在线点扩散函数(PSF)监测。成功的第二阶段B计划和随后的第三阶段商业开发将为临床医生提供高分辨率、高性能的AO成像，成本更低，功能更好，优于其他非AO视网膜成像仪，以帮助指导治疗和改善患者结果。

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.