SBIR-STTR Award

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

Public Health Relevance:
Project Narrative Pediatric Spectral Domain Optical Coherence Tomography 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

Thesaurus Terms:
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Acquiring diagnostic images of the retina in children is necessary to the prevention and treatment of pediatric eye disease, but it is often difficult due to the large range of eye shapes and sizes from preemies to older children and the inability of most children within this range to fixate. Fundus photography only provides a two- dimensional surface picture of the retina, potentially missing information about the disease state. In this Phase II Small Business Innovation Research application, Bioptigen, Inc. proposes to commercialize a handheld spectral domain optical coherence tomography imaging system targeted to meet the specific needs of pediatric patient populations, with additional applications in perioperative imaging and pre-clinical imaging. This Pediatric and Perioperative Spectral Domain Optical Coherence Tomography system (PP-SDOCT) is designed for maximal ease-of use with a non-cooperative patient base with a broad range of physical eye parameters and disease states. The aims of the proposal are to: enable rapid image acquisition through cornea range-finding for coarse alignment, range tracking for fine alignment, smooth focus adjustment for + 12D correction without affecting alignment, and improved footpedal control for hands-free image acquisition;capture wide-field of view, high- speed, and high-resolution structural and functional retinal images;and clinically validate the new product in preparation for an FDA 510(k) submission. The PP-SDOCT system will be designed with wide field of view optics (80 degrees), high axial resolution (3.2 um), high lateral resolution (6 um), a deep imaging window (3.2 mm), and high-speed acquisition (34 frames per second acquisition, processing, and display). The FDA requires clinical data to support 510(k) clearance of a Class II device. To that end, we have arranged collaborations with leading clinicians at Bascom Palmer Eye Institute, Boston Children's Hospital, Los Angeles Children's Hospital, Duke University Eye Center, and the Medical College of Wisconsin to acquire images on neonates through pre-adolescents, including normals, and patients suffering from or suspected of suffering from ROP or plus disease, retinal degenerative disease, or pediatric glaucoma. Imaging will be in the NICU, exam-under anesthesia, and on awake children. Our expectation is to exit the Phase II program with a fully developed, multi-modality, portable handheld imaging system that offers a new standard of care for a deserving, and often underserved, population.

Public Health Relevance:
Acquiring diagnostic images of the retina in children is necessary to the prevention and treatment of pediatric eye disease, but it is often difficult due to the large range of eye shapes and sizes from preemies to older children and the inability of most children within this range to focus on an imaging target during the test. Current imaging methods only provide a two-dimensional surface picture of the retina, potentially missing information about the disease state. Bioptigen is proposing the development of a handheld medical device, the Pediatric and Perioperative Spectral Domain Optical Coherence Tomography (PP-SDOCT) imaging system, which will enable photographers to rapidly acquire both depth slices and blood flow information non-invasively in pediatric eyes and could greatly aid in the research and treatment outcomes of pediatric eye disease.

Thesaurus Terms:
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