Ultrahigh speed, widefield OCT angiography system for patients who are unable to cooperate - systemic and ocular diseases affecting retinal vascular development, perfusion, and neovascularization…

Ultrahigh speed, widefield OCT angiography system for patients who are unable to cooperate - systemic and ocular diseases affecting retinal vascular development, perfusion, and neovascularization are preventable causes of moderate to severe vision impairment in millions of people worldwide. While many adults can cooperate with and hold still for advanced retinal imaging, a significant number of patients including infants, young children, and older patients who, due to sickness, mobility, anesthesia, or a variety of other reasons, are unable to cooperate (i/y/UC patients) cannot. These patients are often the youngest and/or sickest patients who are at the highest risk of vascular, neurovascular, or ischemic disease that can affect the eye. At present, these patients cannot access advanced imaging technologies that would provide valuable diagnostic information and would contribute to advancing our understanding of their diseases. Optical coherence tomography (OCT) is the gold standard for diagnosis of retinal diseases. OCT angiography (octa) is a functional extension of OCT that enables non-invasive, depth resolved imaging of retinal microvasculature without the need for exogenous contrast agents. Because of its dense sampling requirements, octa requires long scans and compliant patients who can hold their head and eyes steady. While large tabletop systems can simplify imaging with active tracking, i/y/UC patients typically cannot position at a chinrest for the duration of the scan. We believe that the development of an ultra-high-speed commercial handheld octa device would provide physicians a valuable research and diagnostic tool for imaging of these underserved patients. Under previous NIH funding, theia imaging has developed the T1-a, a 600 KHZ octa system and the T2 a commercial OCT system with a modular scanner. Here, we propose to leverage these designs to develop the theia angiography module (the T2-a) an upgrade to the T2 system that can bring state-of-the-art widefield octa imaging to bedside. This will be achieved through the following specific aims. Aim 1: development of an enhanced imaging depth, 800 KHZ octa engine. We will develop an 800 KHZ OCT system optimized for octa. Aim 2: development of octa segmentation and image capture workflow. We will capture a data set to train a neural network to provide the segmentation needed for octa and implement an octa imaging capture workflow that assists in the capture of motion free images. Aim 3 q submission, pivotal study and 510(k) submission. We will execute a regulatory strategy that results in a 510(k) submission for the T2-a. The expected outcome of this proposal is the development of an ultra-high-speed, handheld octa imaging tool, ready for clinician-scientists and caregivers to use to gather vascular data that would otherwise be inaccessible. This tool will improve the care of these underserved populations. Upon successful completion of this project, we will submit a follow-on phase II proposal to the system, construct additional prototype devices, and work with collaborators to perform a multi-center clinical study to obtain necessary validation data for 510(k) and other regulatory clearances.