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 ;