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Pediatric Spectral Domain Optical Coherence Tomography

儿科谱域光学相干断层扫描

基本信息

批准号：
8429508
负责人：
Eric L. Buckland
金额：
$ 107.33万
依托单位：
BIOPTIGEN, INC.
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-05-01 至 2015-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8429508
关键词：
Adolescent Adult Affect Algorithms Anesthesia procedures Architecture Blood flow Boston Child Childhood Clinic Clinical Clinical Data Collaborations Computer software Cornea Databases Degenerative Disorder Development Devices Diagnostic Imaging Disease Electromagnetics Eye Eye diseases Feedback Fluorescein Fluorescein Angiography Fluorescence Functional Imaging Fundus Fundus photography Glaucoma Hand Image Image Analysis Infant Institutes Lateral Length Location Los Angeles Medical Device Modality Modification Operative Surgical Procedures Optical Coherence Tomography Optics Pathology Patients Pediatric Hospitals Perioperative Phase Population Posture Preparation Prevention Process Research Resolution Retina Retinal Retinal Degeneration Retinal Diseases Safety Shapes Site Slice Small Business Innovation Research Grant Speed Surface System Testing Time Treatment outcome Underserved Population Universities Validation Visual Wisconsin arm awake base commercialization design expectation eye center fluorescence imaging imaging modality improved medical schools meetings neonate operation optical imaging patient population portability pre-clinical programs prototype sample fixation standard of care tool two-dimensional

项目摘要

Project Summary 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.

项目总结