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

一个集成软件平台，用于加速图像驱动的眼科研究并为临床带来新的见解和终点

• 批准号: 10631602
• 负责人: Eric L. Buckland
• 金额: $ 21.29万
• 依托单位: TRANSLATIONAL IMAGING INNOVATIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10631602
• 关键词: Academy; Address; Adoption; Age related macular degeneration; American; Automobile Driving; Back; Biological Markers; Clinic; Clinical Research; Clinical Trials; Code; Collection; Communities; Community Developments; Computer software; Consensus; Data; Data Discovery; Development; Devices; Diabetic Retinopathy; Digital Imaging and Communications in Medicine; Ensure; Eye diseases; Glaucoma; Healthcare; Image; Metadata; Methods; Modeling; National Eye Institute; Ophthalmology; Pain; Patients; Reading; Research; Specific qualifier value; System; Translating; Translations; Vision; Visualization; biomarker discovery; data lake; data standards; direct application; efficacy testing; falls; image archival system; image processing; imaging modality; imaging platform; innovation; insight; interoperability; new technology; non-compliance; ocular imaging; research and development; safety testing; tool

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-

项目摘要 翻译成像创新（TII）正在创建一个集成平台，用于集合，策展，分析 并共享眼图和数据。我们集成的转化成像™平台集成了电子 带有图像存储库或数据湖的研究工作流管理系统，并为 控制图像和数据流向可视化和图像处理工具包。我们现在解决一个特定的 眼科和视觉社区中的痛点：DICOM符合。 2021年，FDA正式 公认的DICOM是眼科管理系统的共识标准，而民族眼 研究所和美国眼科学院发出了呼吁，请呼吁获得眼科设备社区以加速 采用DICOM。眼科的DICOM包括12个独立的标准。构建DICOM图像文件 需要a）将专有（或非数字）图像文件转换为DICOM图像对象，b）填充 带有元数据的DICOM标签。 DICOM指定所需的标签和可选标签（什至标准号码标签） 并允许使用非标准的专有标签（奇数）。不符合图像格式和专有标签 在眼科中是广泛的，尤其是在10月。因此，我们建议构建DICOM图像生成器 进入tii ocuvault API，并将DICOM渲染纳入Tii Image Curation应用程序Oculink。 将DICOM阅读和翻译功能添加到Oculink和Ocuvault中可以解决重大问题 对于眼科研发社区。我们提供了一个引擎来控制 图像回到所有者。我们采用透明，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 不存在DICOM补充剂的图像方式，加速了新技术的协调 在眼科不断发展中。 我们的目标如下：1）实施DICOM渲染到Oculink； 2）开发翻译专有的方法 图像格式为DICOM； 3）开发一个Ocuvault - to - DICOM元数据映射软件实用程序； 4）开发一个 任何 - 到 - DICOM导出方法； 5）为没有 嵌入式元数据； 6）将Oculink和Ocuvault提交FDA 510（k）清除为眼部成像 管理系统（FDA产品代码NFJ）。 -1-