SBIR-STTR Award

Optical coherence tomography (OCT) is the gold standard for the diagnosis and monitoring of retinal andoptic nerve diseases. Most clinical OCT systems are large tabletop devices that require a compliant subject,and thus are not suitable for use with infants, young children, and patients who are unable to cooperate for eyeimaging (such as from physical disability or during eye examination under anesthesia). As many of thesepatients cannot communicate about vision disturbance or vision loss, diagnosis of disease in these patients isdifficult to achieve before irrevocable vision loss occurs. One example is preterm infants at risk for retinopathyof prematurity (ROP) who make up 1.4% of the newborn population. While handheld OCT (HH-OCT) has led tosignificant insights into the development of ROP, the use of HH-OCT for disease screening has been limiteddue to the poor usability of existing commercial systems. Capturing images in awake infants with thesesystems is challenging, requiring specialized research staff with significant training. There is a need for apoint of care, high-speed, user-friendly handheld OCT system to improve the standard of care ofinfants, young children, and patients who are unable to cooperate for imaging. Theia Imaging is led by a team of experts in the development HH-OCT systems. Our long-term objectiveis to develop a point of care, high speed, user-friendly, handheld OCT system to enable clinicians andresearchers to gather much-needed OCT imaging of the retina and/or optic nerve head of theirpatients. This will decrease the need for examinations under anesthesia and simplify access to valuableinformation about the retina and optic nerve head at the time of eye care and general health care. Through the following specific aims, we will begin the process of translating such an HH-OCT system, withimproved speed, ergonomics, and usability as compared to commercially available systems. Specific Aim 1:Develop a Portable, High-Speed OCT System with Ergonomic, User-Friendly Handheld Probe. We willdevelop a 300 kHz OCT system (the fastest medical OCT system of any kind) with a lightweight, ergonomichandheld probe. Specific Aim 2: Develop Real-Time, Workflow-Optimized OCT Capture Software. We willdevelop real time, OCT acquisition software for the 300 kHz OCT system engine and an intuitive workflow-optimized user interface/user experience. Specific Aim 3: Validation Study. Use of the proposed HH-OCTsystem will be compared to current commercial HH-OCT systems in a validation study. The expectedoutcome of this proposal is the development and validation of a prototype high-speed, user-friendly HH-OCTsystem and software usable by ophthalmic and optometric technicians without the need for specializedtraining. We believe that the commercialization of this system will greatly improve the standard of eye care andgeneral health care for infants, young children and patients unable to cooperate for eye imaging.

Public Health Relevance Statement:
NARRATIVE Infants, young children and patients with certain mental and physical disabilities are unable to communicate about loss or disturbance of vision, making it difficult to diagnosis vision-threatening diseases in these patient populations before irrevocable vision loss. While handheld OCT can be used to screen for and diagnose eye disease in these patients, adoption of these systems has been limited, largely due to poor usability of the existing commercial devices. In this Small Business Innovation Research proposal, we will develop a user-friendly, handheld OCT system that will substantially improve the standard of care for infants, young children, and patients who are currently underserved by existing OCT systems.

Project Terms:
Retinopathy of Prematurity ; Retrolental Fibroplasia ; premature retinopathy ; Risk ; Computer software ; Software ; Supination ; Technology ; Time ; Translating ; Translations ; Vision ; Sight ; visual function ; Visual impairment ; Diminished Vision ; Low Vision ; Partial Sight ; Reduced Vision ; Subnormal Vision ; vision impairment ; visually impaired ; Voice ; Work ; Generations ; Intensive Care ; Businesses ; ergonomics ; Healthcare ; health care ; physically handicapped ; physical disability ; physically disabled ; Caring ; base ; improved ; Ophthalmic examination and evaluation ; Eye Exam ; Eye Examination ; Clinical ; Phase ; Medical ; Training ; Psyche structure ; mental ; insight ; Intuition ; awake ; diabetic ; Age related macular degeneration ; Age-Related Maculopathy ; age related macular dystrophy ; senile macular disease ; School-Age Population ; school age ; Multicenter Studies ; Multi-center studies ; Point-of-Care Systems ; lightweight ; light weight ; Diagnostic ; programs ; System ; vision loss ; visual loss ; Blindness ; Examination Under Anesthesia ; experience ; Speed ; novel ; validation studies ; Devices ; Position ; Positioning Attribute ; portability ; Doppler OCT ; OCT Tomography ; optical Doppler tomography ; optical coherence Doppler tomography ; Optical Coherence Tomography ; diagnosis standard ; image-based method ; imaging method ; imaging modality ; Address ; Data ; Resolution ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Validation ; Monitor ; Process ; Development ; developmental ; point of care ; Image ; imaging ; Operating System ; design ; designing ; Outcome ; Population ; user-friendly ; usability ; stem ; prototype ; commercialization ; patient population ; standard of care ; disease diagnosis ; screening ; non-invasive imaging ; noninvasive imaging ; pediatric patients ; child patients ; imager ; retinal imaging ; retina imaging ; Adoption ; Angiography ; Angiogram ; angiographic imaging ; Archives ; Child ; 0-11 years old ; Child Youth ; Children (0-21) ; youngster ; Diagnosis ; Disease ; Disorder ; Eye ; Eyeball ; Eye diseases ; eye disorder ; ophthalmopathy ; Feedback ; fovea centralis ; Fovea ; Gold ; Infant ; Infant Care ; baby care ; infant health care ; infant healthcare ; newborn care ; Newborn Infant ; 0-4 weeks old ; Newborns ; newborn child ; newborn children ; Premature Infant ; infants born premature ; infants born prematurely ; premature baby ; premature infant human ; preterm baby ; preterm infant ; preterm infant human ; United States National Institutes of Health ; NIH ; National Institutes of Health ; Optic Disk ; Optic Nerve Head ; Optic Papilla ; Optic Nerve ; Cranial Nerve II ; Second Cranial Nerve ; optic nerve disorder ; Cranial Nerve II Diseases ; Cranial Nerve II Disorder ; Neural-Optical Lesion ; Optic Nerve Diseases ; Optic Neuropathy ; Second Cranial Nerve Diseases ; second cranial nerve disorder ; Legal patent ; Patents ; Patients ; Publications ; Scientific Publication ; Publishing ; Pupil ; Reading ; Refractive Errors ; Refractive Disorders ; eye refraction disorder ; Research ; Research Personnel ; Investigators ; Researchers ; Research Proposals ; Rest ; Retina ; Retinal Diseases ; Retinal Disorder ; retina disease ; retina disorder ; retinopathy ;

Optical coherence tomography (OCT) is the gold standard for the diagnosis and monitoring of retinal andoptic 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 eyeimaging (such as from physical disability or while under anesthesia or in intensive care). As many of thesepatients cannot communicate about vision disturbance or vision loss, diagnosis of disease is difficult to achievebefore irrevocable vision loss occurs. One example of this population is preterm infants in intensive care andwho are at risk for retinopathy of prematurity (ROP). While handheld OCT (HH-OCT) has led to significantinsights into the development of ROP, its use for disease screening has been limited in part due to poorusability of the existing commercial systems due to weight, ergonomics and speed of imaging. The need forimage-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 toimprove 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-heldOCT system for use in these patients. Our long-term objective is to enable clinicians and researchers to gathermuch-needed OCT imaging of the retina and/or optic nerve head in their patients. This will decrease the needfor examinations under anesthesia and simplify access to valuable information about the retina and optic nervehead 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 highspeed 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 probeand 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 qualityassurance system and improve usability. Aim 3: Pilot Study, Pivotal Study and 510(k) Submission. With therefined Theia 2 system, we will execute pilot and pivotal human studies in support of a 510(k) submission Theexpected outcome of this proposal is the development of a commercially viable, 300 kHz HH-OCT system anda 510(k) submission for FDA clearance of the device. Both the device and associated software will bedesigned to be usable by ophthalmic technicians without the need for specialized training.

Public Health Relevance Statement:
NARRATIVE Handheld OCT can be used to screen for and diagnose eye disease in infants, young children and many patients in intensive care or with certain disabilities, who are unable to cooperate for conventional tabletop imaging and are unable to communicate about loss or disturbance of vision, making it difficult to diagnosis vision- threatening diseases before irrevocablevision loss occurs. Because adoption of handheld OCT has beenlimited, largely due to poor usability of existing commercial devices, Theia Imaging is pursuing commercialization of a high-speed, portable, user-friendly, hand-held OCT system for use in this population. The commercialization of the Theia system will substantially improve the health care of patients who are currently underserved by existing OCT devices.

Project Terms:
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