Optical coherence tomography (OCT) is the standard of care for the diagnosis and monitoring of adult retinaldiseases. However, most clinical OCT devices are large tabletop systems that are not suitable for use withinfants, young children, and patients that are unable to cooperate (I/YC/UC patients). As these patients cannotcommunicate about disturbances to their vision, diagnosis of disease in these patients is difficult to achievebefore the disease causes irrevocable vision loss. One group of such patients are preterm infants at risk forretinopathy of prematurity (ROP), who comprise 1.4% of the newborn population. Currently, most imaging ofI/YC/UC patients is performed with visible light fundus imaging, the previous standard of care for adults. Thereare notable drawbacks to examinations with visible fundus cameras in I/YC/UC patients including patientdiscomfort, stress (particularly for infants), and the presence of image artifacts (glare, low contrast from funduspigmentation, 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 theprogression and management of ROP. However, HH-OCT has seen limited adoption due to 3 major limitationswith existing commercial devices: (1) they are heavy and slow; (2) have limited fields-of-views (FOV) comparedto wide-field fundus cameras; and (3) provide virtually no image analysis capability. We believe that thedevelopment of a commercial handheld OCT system that comes with an interchangeable widefieldimaging tip and image analysis capabilities will significantly improve the diagnostic utility of HH-OCTfor 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 isthe development of imaging systems that will bring state of the art imaging capabilities to the bedside of I/YC/UCpatients. These systems will decrease the need for examinations under anesthesia and provide clinicians withvaluable diagnostic information. Under current NIH support, Theia imaging is addressing the first limitation listedabove 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 BusinessInnovation Research proposal, we propose to address limitations 2 and 3 via the following specific aims. SpecificAim 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 anovel scan pattern optimized for wide FOV. Specific Aim 2: Development of Widefield OCT Segmentation,Analysis, and Visualization Software. We will acquire initial data and develop segmentation/visualizationalgorithms for the wide field data. The expected outcomes of this proposal are the development of a portable,widefield, HH-OCT system and software that can provide valuable diagnostic information to clinicians.
Public Health Relevance Statement: Optical coherence tomography (OCT) has become the standard of care for the diagnosis and
monitoring of retinal diseases. However, most clinical OCT devices are large tabletop systems,
and are not suitable for use with patients that are unable to sit upright, especially preterm infants
at risk for retinopathy of prematurity (ROP). Under NIH support, Theia Imaging is developing the
Theia T1, a user-friendly, handheld OCT system to improve the standard of care of these patients.
In this Small Business Innovation Research proposal, we propose to expand the capabilities of
the Theia T1 to enable wide-field imaging and sophisticated image analysis software to improve
its diagnostic utility in screening for ROP and diagnosing other retinal diseases.
Project Terms: <21+ years old><0-11 years old><0-4 weeks old>
