Photoreceptor Integrity Software

描述（由申请人提供）：这项研究将对减少美国人的失明和视力丧失产生重大和潜在的广泛影响。许多与失明和视力丧失相关的主要眼部疾病干扰和损害光感受器。这项研究将使研究人员能够研究影响光感受器的疾病和病症的特征，原因和未来的治疗方法。随后的软件产品将产生光感受器完整性层（PIL）和相关的邻近层的图像，所述光感受器完整性层和相关的邻近层是光感受器的内源性标志物并且与许多主要致盲疾病相关联。该软件最初将出售给研究这些疾病的原因和治疗方法的研究人员，随后将用于临床应用，用于评估治疗条件。第一阶段项目涉及算法和软件的研究和开发，这些算法和软件可以在光感受器层及其附近产生光学相干断层扫描的图像和测量结果-最值得注意的是从传统上被认为代表内节/外节结的PIL开始，并且是光感受器的组成部分。这些层在物理上和生理上与光感受器相连，因此它们的损害在许多主要疾病中影响视力丧失，例如年龄相关性黄斑变性、地图状萎缩和色素性视网膜炎。该软件将帮助研究人员表征和研究这些疾病的进展和病理生理学。它将为从业人员提供客观的措施来评估这些条件，以管理治疗。最重要的创新是：（1）它将完全自动化，不需要手动操作，这对从业者来说是必不可少的。(2)为研究和实际临床使用定义了一组独特的图像和测量。(3)一种新的数学方法，首次涉及3D活动表面轮廓和我们小组设计的一种新的优化函数。(4)这将是第一个具有此功能的商业产品。易于 使用图像和测量的目的是研究工具和临床评价工具的双重作用，其中工作流程是重要的。这一商业目标带来了许多挑战，这些挑战将推动算法和软件的进一步创新。第一阶段的项目将集中在第一个原型算法和方法，以产生图像和测量，以证明该技术的可行性。测量包括那些可以反映PIL的任何妥协的参数。可行性将通过显示这些措施显示正常和疾病病例之间的差异来定义。第二阶段将涉及用于研究除了PIL层之外的其他层的算法和图像，这些层在生理上和物理上连接到光感受器，包括视网膜色素上皮和外部界膜。视网膜和脉络膜中其他层的检测和可视化将是这项工作的自然结果，因此最终产品将具有客户所需的丰富功能，除了与光感受器相关的层的成像和测量之外，尽管第一阶段和第二阶段工作的重点和目标将与光感受器相关。 公共卫生相关性：这项研究将对减少美国人的失明和视力丧失产生重大和潜在的广泛影响。许多导致失明和视力丧失的主要眼部疾病都伴随着受损的光感受器。这项研究将使研究人员能够研究影响光感受器的疾病和病症的特征，原因和未来的治疗方法。随后的软件产品将产生光感受器完整性层（PIL）和相关的邻近层的图像，所述光感受器完整性层和相关的邻近层是光感受器的内源性标志物并且与许多主要致盲疾病相关联。该软件最初将出售给研究这些疾病的原因和治疗方法的研究人员，随后将用于临床应用，用于评估治疗条件。该项目的主题是研究和开发算法和软件，从与光感受器相关的光学相干断层扫描（OCT）视网膜层（最值得注意的是最初的光感受器完整性层（PIL））产生测量和图像。该软件旨在研究，表征和管理干扰光感受器的条件的治疗。PIL和这些其他层的干扰（例如，视网膜色素上皮和外部界膜），因为它们在物理上和生理上与光感受器（眼睛的感光元件）相连，在常见的致盲疾病和病症中影响视力，所述致盲疾病和病症例如年龄相关性黄斑变性（AMD）、地图状萎缩（AMD的一种病症）、色素性视网膜炎、黄斑毛细血管扩张症等。该软件的最早版本将为研究人员提供工具，以表征和研究这些疾病的进展和生理学。稍后的版本将提供客观的图像和措施，为从业人员评估这些条件和管理治疗。该软件产品将产生易于理解的措施，专门针对研究工具和临床评价工具的双重作用，其中临床工作流程很重要。将制作一个原型，最终形成一个易于许多研究人员和从业人员使用的商业软件包。

DESCRIPTION (provided by applicant): This research will have a significant and potentially broad impact on reducing blindness and vision loss of Americans. Many predominant eye conditions, associated with blindness and vision loss, disturb and compromise the photoreceptors. This research will enable researchers to study the characteristics, causes and future treatments of diseases and conditions that affect photoreceptors. The ensuing software product will produce images of the photoreceptor- integrity layer (PIL), and related nearby layers, which are endogenous markers of the photoreceptors and are linked to many predominant blinding diseases. The software will be sold initially to researchers of the causes and treatments of these diseases and, later, it will be aimed at clinical use, for evaluating conditions to manage treatments. The Phase I project involves the study and development of algorithms and software that produce images and measurements from optical coherence tomography in and near the photoreceptor layer - starting most notably with the PIL that is traditionally thought to represent the inner-segment/outer-segment junction and is a component of the photoreceptors. These layers are connected physically and physiologically to the photoreceptors, so their compromise affects vision loss in many predominant conditions such as age-related macular degeneration, geographic atrophy and retinitis pigmentosa. The software will help researchers characterize and study the progression and pathophysiology of these conditions. It will provide objective measures for practitioners to evaluate these conditions to manage treatment. The most important novelties are: (1) It will have full automation, with no manual operations needed, which is essential for practitioners. (2) A unique set of images and measures are defined for research and practical clinical use. (3) A novel mathematical approach that involves, for the first time, 3D active surface contours and a novel optimization function designed by our group. (4) It will be the first commercial product with this functionality. Easy-to use images and measures are aimed at the dual role of a research tool and a clinical evaluation tool where workflow is important. This commercial aim causes many challenges that will drive further innovations of the algorithms and software. The Phase I project will focus on the first prototype algorithms and approaches to producing images and measurements, in order to demonstrate the feasibility of the technology. Measurements include those of parameters that could reflect any compromise of the PIL. Feasibility will be defined by showing that these measures show a difference between normal and disease cases. Phase II will involve algorithms and images for studying other layers besides the PIL layer that are connected physiologically and physically to the photoreceptors, including the retinal pigment epithelium and external limiting membrane. The detection and visualization of other layers in the retina and choroid will be a natural fallout of this work, so the end product will have a wealth of functionalty demanded by the customers, besides imaging and measurement of layers relevant to the photoreceptors, although the focus and aim of the Phase I and Phase II work will be associated with the photoreceptors. PUBLIC HEALTH RELEVANCE: This research will have a significant and potentially broad impact on reducing blindness and vision loss of Americans. Many predominant eye conditions that cause blindness and vision loss are accompanied by compromised photoreceptors. This research will enable researchers to study the characteristics, causes and future treatments of diseases and conditions that affect photoreceptors. The ensuing software product will produce images of the photoreceptor- integrity layer (PIL), and related nearby layers, which are endogenous markers of the photoreceptors and are linked to many predominant blinding diseases. The software will be sold initially to researchers of the causes and treatments of these diseases and, later, it will be aimed at clinical use, for evaluating conditions to manage treatments. The theme of this project is the study and development of algorithms and software that produce measurements and images from optical coherence tomography (OCT) retinal layers associated with the photoreceptors - most notably and initially the photoreceptor-integrity layer (PIL). The software is intended for studying, characterizing and managing treatment of conditions that disturb the photoreceptors. The disturbance of the PIL and these other layers (e.g., retinal pigment epithelium and external limiting membrane), because they are connected physically and physiologically to the photoreceptors (photosensitive elements of the eye), affect vision in common blinding diseases and conditions such as age- related macular degeneration (AMD), geographic atrophy (a condition of AMD), retinitis pigmentosa, macular telangiectasia and others. The software's earliest version will have tools for researchers to characterize and study the progression and physiology of these conditions. A later version will provide objective images and measures for practitioners to evaluate these conditions and manage treatment. The software product will produce easy-to-understand measures specifically aimed at the dual role of a research tool and a clinical evaluation tool where workflow of the clinic is important. A prototype will be produced that leads to a commercial software package that is easy to use by many researchers and practitioners.