Bioptigen SBIR Phase I resubmittal: Pediatric OCT

DESCRIPTION (provided by applicant): This Phase I Small Business Innovative Research application proposes to introduce for the first time to commercial availability a spectral domain optical coherence tomography (SDOCT) system specifically designed for pediatric patients. OCT is a well-established technology for ophthalmic imaging, using low-coherence interferometry to non-invasively obtain cross-sectional images in living tissues with micron-scale resolution.. Bioptigen, Inc., a startup company affiliated with Duke University, has developed a state- of-the-art retinal SDOCT system using chinrest-mounted delivery optics under prior SBIR Phase I/II support, and has brought this slit-lamp based system to market. Bioptigen has also prototyped rudimentary handheld probes for use with immobile human patients and animal subjects. There has been significant pull from the user community for improvements to these handheld probes for pediatric and infant/neonatal applications, particularly for improvements in alignment and focus. Bioptigen proposes to develop new technology for a practical handheld SDOCT interface and associated system functionality which will make the considerable benefits of ophthalmic SDOCT imaging available to pediatric and infant/neonatal patient populations for the first time. The specific aims of the proposal are as follows: Specific Aim 1: Develop and prototype a handheld SDOCT device for pediatric imaging, to include: a) High-speed OCT scanning optics (with expanded FOV and EasyDriveTM (akin to an iris camera') performance for ease of use, suitable for 2 and 3-D retinal imaging, b) Calibrated manual twist focus control capable of +20 Diopter adjustment, c) All of the above in a size and weight suitable for hand-held operation. Specific Aim 2: Develop and prototype a design for a pediatric SDOCT system, to include: a) Design of the housing for the handheld probe to incorporate the new optical design b) Electro-mechanical control of the reference arm delay to match subject eye length, c) Construct a fully functioning engineering prototype incorporating these features. Specific Aim 3: To integrate and test the optical and electromechanical designs, including: a) Develop firmware and software control for the hardware improvements, b) Develop an OCT-specific adjustable eye model for testing and training, c) Test image quality on eye models and phantoms, and (under the aegis of Dr. Freedman's IRB) on adult human volunteers. PUBLIC HEALTH RELEVANCE: Spectral Domain Optical Coherence Tomography (SDOCT) dramatically improves the visualization of retinal pathologies through the real-time acquisition of densely sampled high resolution volumetric images. The pediatric patient population is not served by current OCT instrumentation. Other than Retcam , a handheld fundus camera, there are simply no diagnostic tools available today to support early diagnosis and prediction of pediatric ophthalmic disease progression. Bioptigen recognizes the need for a handheld SDOCT imaging system with variable eye-length adjustment and focus, and unsurpassed ease of use. In this project, we propose to develop a hand held multi-function SDOCT imaging system, offering high speed, high resolution contact and non-contact SDOCT imaging, new optics to improve field of view, alignment and registration, and automated control of reference arms length to match axial length in a wide range of pediatric and other patient groups. This development follows directly from successful implementation in an adult system, and will offer superior quality SDOCT imaging to the underserved pediatric clinical community. Bioptigen confidential