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-

项目概要 Translational Imaging Innovations (TII) 正在创建一个用于收集、管理、分析的综合平台 我们的 Integrated Translational Imaging™ 平台集成了电子设备。 研究具有图像存储库或数据湖的工作流管理系统，并提供方法 控制图像和数据流向可视化和图像处理工具包。 眼科和视觉界的痛点：2021 年 DICOM 合规性。 认可 DICOM 为眼科图像管理系统和国家眼科的共识标准 研究所和美国眼科学会向眼科器械界发出加速发展的号召 眼科采用 DICOM。 DICOM 包含 12 个独立的标准。 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 指定必需的标签和可选标签（每个标准的偶数标签）。 并允许使用非标准专有标签（奇数）。 在眼科领域广泛存在，特别是在 OCT 领域，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 渲染合并到 TII 图像管理应用程序 ocuLink 中。 ocuLink 和 ocuVault 中添加 DICOM 读取和翻译功能解决了重大问题 我们为眼科研究和开发社区提供了一个用于控制的引擎。 我们应用透明、统一的模型来确保 DICOM 标准工具。 可以使用 .DCM 文件，同时在必要时保留专有信息。 DICOM 补充不存在的图像模式，加速新技术的协调 眼科不断发展。 我们的目标如下： 1) 将 DICOM 渲染实施到 ocuLink 中 2) 开发翻译专有方法； 图像格式到 DICOM；3) 开发 ocuVault 到 DICOM 元数据映射软件实用程序； 任何 - 到 - DICOM 导出方法；5) 为不具有 DICOM 的文件开发符合 DICOM 的元数据填充实用程序 嵌入元数据；以及 6) 提交 ocuLink 和 ocuVault 作为眼科成像以获得 FDA 510(k) 许可 管理系统（FDA 产品代码 NFJ）。 -1-