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

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-