Ophthalmic imaging is of critical importance to ocular disease management and, increasingly, as a window to neurodegenerative and systemic diseases. Optical coherence tomography (OCT) is its most important modality, but also its most problematic in terms of interoperability, storage and unified analyses. Much of this is to do with incompatible instruments and data formats. Rapid advances in radiology resulted from the DICOM standardization of image data, facilitating more collaborative work, better data insight, device independence and innovative developments that today have spawned multiple independent vendors offering processing and archival solutions. For OCT, no such solution exists and, as a direct result, despite being the standard of care, the clinical data remains under-utilized and the research fragmented. Open formats reduce overall costs and can ultimately lead to better patient outcomes. This project will establish the first, commercial grade, cloud-based, truly vendor neutral, DICOM compliant, image and information storage and processing platform for ophthalmic OCT. The proposed system will bring the functionality, interoperability, and innovation of radiology to ophthalmology. The project has the following clear and achievable milestones: 1) Develop Nebula, a cloud-based, DICOM-compliant, image storage and archive platform. This will be built with security as the primary consideration and will natively support patient management systems. 2) Add a web-based analysis front-end to Nebula optimized for clinical ophthalmic workflows. 3) Build on our Phase I award, and implement, validate and release AI-based AMD prognostics, OCT-angiography analytics and retinal fluid quantification software. 4) Apply for regulatory approval for both Nebula?s picture archiving and communications (PACS) for ophthalmology and the fluid quantification module. This will allow for clinical use of the system and serve as a platform for a wide variety of ophthalmic and neurologic research. We have received significant interest in the proposed work from researchers, ophthalmologists, and optometrists. And, toward these ends, we have assembled a team of experts to manage, implement, validate, and release this software. That is, to achieve all the aims presented.

Public Health Relevance

This project will build the first cloud-based, truly vendor neutral, DICOM compliant, image and information storage and processing platform for ophthalmic optical coherence tomography (OCT) imagery. It will bring the functionality, interoperability, and AI-enabled innovation of radiology to ophthalmology. It will speed up the pace of innovation, support telemedicine, and, ultimately, offer better patient outcomes for diseases such as AMD, diabetic retinopathy, glaucoma, Alzheimer?s, Parkinson?s, and MS - diseases that affect millions of Americans.

Agency
National Institute of Health (NIH)
Institute
National Center for Advancing Translational Sciences (NCATS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44TR001890-02A1
Application #
10255740
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Brazhnik, Olga
Project Start
2017-02-01
Project End
2023-02-28
Budget Start
2021-03-15
Budget End
2022-02-28
Support Year
2
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Voxeleron, LLC
Department
Type
DUNS #
040871521
City
Pleasanton
State
CA
Country
United States
Zip Code
94588