An Integrated Software Platform for Accelerating Image-Driven Ophthalmic Research and Driving New Insights and Endpoints to the Clinic

项目摘要 翻译影像创新(TII)正在创建一个集收集、整理、分析 以及眼睛图像和数据的共享。我们的集成平移成像™平台集成了电子 研究具有图像库或数据湖的工作流管理系统，并提供以下方法 控制流向可视化和图像处理工具包的图像和数据流。我们现在处理的是一个特定的 眼科和视觉界的痛点：符合DICOM标准。2021年，FDA正式 被公认为眼科图像管理系统的共识标准和国家眼睛 美国眼科学会和美国眼科学会呼吁眼科设备社区加快 采用DICOM。DICOM眼科标准由12个不同的标准组成。构建DICOM图像文件 需要a)将专有(或非DICOM)图像文件转换为DICOM图像对象，以及b)填充 带有元数据的DICOM标签。DICOM指定了必需的标签和可选的标签(标准中的偶数标签) 并且允许非标准专有标签(奇数)。不符合要求的图像格式和专有标签 在眼科中广泛存在，尤其是在10月。因此，我们建议构建一个DICOM图像生成器 集成到TII ocuVault API中，并将DICOM渲染集成到TII图像管理应用程序ocuLink中。 在ocuLink和ocuvault中添加DICOM读取和翻译功能解决了重大问题 为眼科研究和发展社区服务。我们提供了一个引擎，用于控制 把照片还给车主。我们应用了一个透明、协调的模型，以确保DICOM标准工具 可以使用.DCM文件，同时在必要时维护专有信息。我们将DICOM模型应用于 在没有DICOM补充的情况下进行成像，加快新技术的协调 在眼科的不断发展中。 我们的目标是：1)将DICOM渲染实现到ocuLink；2)开发方法来转换专有的 将图像格式转换为DICOM；3)开发ocuVault到DICOM元数据映射软件实用程序；4)开发 Any-to-DICOM导出方法；5)为没有以下文件的文件开发符合DICOM的元数据填充实用程序 嵌入的元数据；以及6)将ocuLink和ocuVault作为眼科成像提交FDA 510(K)许可 管理系统(FDA产品代码NFJ)。 -1-

Project Summary Translational Imaging Innovations (TII) is creating an integrated platform for the collection, curation, analysis and sharing of ocular images and data. Our Integrated Translational Imaging™ platform integrates an electronic research workflow management system with an image repository, or data lake, and provides methods for controlling the flow of images and data to a visualization and image processing toolkit. We now address a specific pain point within the Ophthalmology and Vision community: DICOM conformance. In 2021, the FDA officially recognized DICOM as a consensus standard for Ophthalmic Image Management Systems, and the National Eye Institute and American Academy of Ophthalmology issued a call to the ophthalmic device community to accelerate adoption of DICOM. DICOM for ophthalmology consists of 12 separate standards. Building a DICOM image file requires a) transforming a proprietary (or non-DICOM) image file into a DICOM image object, and b) populating DICOM tags with metadata. DICOM specifies required tags and optional tags (even number tags per the standard) and allows for non-standard proprietary tags (odd-numbered). Non-compliant image formats and proprietary tags are widespread in ophthalmology, particularly in OCT. We therefore propose to build a DICOM image generator into the TII ocuVault API and incorporate DICOM rendering into the TII image curation application, ocuLink. The addition of DICOM reading and translation capabilities into ocuLink and ocuVault solves significant problems for the ophthalmic research and development community. We provide an engine for providing control of the images back to the owner. We apply a transparent, harmonized model that ensures that DICOM standard tools can use .DCM files, while maintaining proprietary information where necessary. We apply the DICOM model to image modalities where a DICOM supplement does not exist, accelerating the harmonization of new technologies in constant development in ophthalmology. Our AIMS are as follows: 1) Implement DICOM rendering into ocuLink; 2) Develop methods to translate proprietary image formats to DICOM; 3) Develop an ocuVault – to – DICOM metadata mapping software utility; 4) Develop an any – to – DICOM export method; 5) Develop DICOM-conformant metadata fill utility for files that do not have embedded metadata; and 6) submit ocuLink and ocuVault for FDA 510(k) clearance as an Ophthalmic Imaging Management Systems (FDA Product Code NFJ). -1-