A Widefield, Handheld OCT system for Patients who are Unable to Cooperate

Optical coherence tomography (OCT) is the standard of care for the diagnosis and monitoring of adult retinal diseases. However, most clinical OCT devices are large tabletop systems that are not suitable for use with infants, young children, and patients that are unable to cooperate (I/YC/UC patients). As these patients cannot communicate about disturbances to their vision, diagnosis of disease in these patients is difficult to achieve before the disease causes irrevocable vision loss. One group of such patients are preterm infants at risk for retinopathy of prematurity (ROP), who comprise 1.4% of the newborn population. Currently, most imaging of I/YC/UC patients is performed with visible light fundus imaging, the previous standard of care for adults. There are notable drawbacks to examinations with visible fundus cameras in I/YC/UC patients including patient discomfort, stress (particularly for infants), and the presence of image artifacts (glare, low contrast from fundus pigmentation, etc.) that make evaluation of the images challenging. OCT does not suffer from these drawbacks. In addition, the use of commercial handheld OCT (HH-OCT) systems has led to significant insights into the progression and management of ROP. However, HH-OCT has seen limited adoption due to 3 major limitations with existing commercial devices: (1) they are heavy and slow; (2) have limited fields-of-views (FOV) compared to wide-field fundus cameras; and (3) provide virtually no image analysis capability. We believe that the development of a commercial handheld OCT system that comes with an interchangeable widefield imaging tip and image analysis capabilities will significantly improve the diagnostic utility of HH-OCT for screening of diseases such as ROP and ultimately improve the standard of care for I/YC/UC patients.Theia Imaging is led by a team of experts in the development HH-OCT systems. Our long-term objective is the development of imaging systems that will bring state of the art imaging capabilities to the bedside of I/YC/UC patients. These systems will decrease the need for examinations under anesthesia and provide clinicians with valuable diagnostic information. Under current NIH support, Theia imaging is addressing the first limitation listed above via the development and commercialization of the Theia T1 system: an ergonomic, high-speed, user- friendly handheld OCT system to improve the standard of care of I/YC/UC patients. In this Small Business Innovation Research proposal, we propose to address limitations 2 and 3 via the following specific aims. Specific Aim 1: Development of a Modular Handheld OCT Probe with Non-Contact and Widefield Contact Modes. We will develop a modular, widefield, contact tip that can be interchanged with the existing T1 system, and a novel wide FOV scan pattern. Specific Aim 2: Development of Widefield OCT Segmentation, Analysis, and Visualization Software with secure data management. We will acquire initial data and develop segmentation/visualization algorithms for the wide field data. The expected outcomes of this proposal are the development of a widefield, HH-OCT system and software that can provide diagnostic information to clinicians.