ABSTRACT Optical coherence tomography (OCT) is the gold standard for the diagnosis and monitoring of retinal and optic nerve diseases. Clinical OCT systems (large tabletop devices with chinrest) require a compliant subject, and thus are not suitable for use with infants, young children, and patients who are unable to cooperate for eye imaging (such as from physical disability or while under anesthesia or in intensive care). As many of these patients cannot communicate about vision disturbance or vision loss, diagnosis of disease is difficult to achieve before irrevocable vision loss occurs. One example of this population is preterm infants in intensive care and who are at risk for retinopathy of prematurity (ROP). While handheld OCT (HH-OCT) has led to significant insights into the development of ROP, its use for disease screening has been limited in part due to poor usability of the existing commercial systems due to weight, ergonomics and speed of imaging. The need for image-based classification of ROP was a subject of the recent International Classification of ROP Committee. There is a clear need for a commercial, point of care, high-speed, user-friendly handheld OCT system to improve the standard of care for infants, young children, and patients who are unable to cooperate for imaging. Theia Imaging is pursuing commercialization of the Theia 2 high-speed, portable, user-friendly, hand-held OCT system for use in these patients. Our long-term objective is to enable clinicians and researchers to gather much-needed OCT imaging of the retina and/or optic nerve head in their patients. This will decrease the need for examinations under anesthesia and simplify access to valuable information about the retina and optic nerve head at the time of eye care and general health care. This Phase II effort will build on the Theia 1 system developed in the Phase I, to result in an FDA- submission for a handheld system that is lightweight, with a small, ergonomic handpiece and imaging at high speed and a robust commercialization pathway. Theia Imaging will achieve this through the following Aims: Aim 1: Refine the T1 Prototype into a Commercial Medical Device. We will refine both the design of the probe and OCT engine allowing us to scale to production quantities and reduce the overall cost of the device. Aim 2: Refine the T1 Software into a Commercial Product. We will refine this software under a software quality assurance system and improve usability. Aim 3: Pilot Study, Pivotal Study and 510(k) Submission. With the refined Theia 2 system, we will execute pilot and pivotal human studies in support of a 510(k) submission The expected outcome of this proposal is the development of a commercially viable, 300 kHz HH-OCT system and a 510(k) submission for FDA clearance of the device. Both the device and associated software will be designed to be usable by ophthalmic technicians without the need for specialized training.