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.

项目摘要获取儿童视网膜的诊断图像对于预防和治疗小儿是必要的眼病，但由于较大的眼睛形状和大小，从祖先到较旧，这通常很困难儿童和大多数儿童在此范围内无法固定。眼底摄影只提供两个视网膜的尺寸表面图片，可能缺少有关疾病状态的信息。在这一阶段II小型企业创新研究应用程序中，Bioptigen，Inc。建议商业化手持光谱域光学相干断层扫描成像系统针对特定需求小儿患者人群，在围手术成像和临床前成像中有其他应用。这个儿科和围手术期光谱域光学相干断层扫描系统（PP-SDOCT）是专为与非合作患者基础具有广泛的身体眼睛的最大易用性参数和疾病状态。该提案的目的是：通过角膜范围来启用快速图像获取对齐，范围跟踪以进行细胞对齐，对 + 12D校正的平稳焦点调整而不影响对齐，并改善脚踏控制，以获取免提图像的获取；捕获宽阔的视野，高 - 速度以及高分辨率的结构和功能性视网膜图像；并在临床上验证新产品准备FDA 510（k）提交。 PP-SDOCT系统将采用广阔的视野设计光学元件（80度），高轴向分辨率（3.2 um），高侧分辨率（6 um），一个深成像窗口（3.2 MM）和高速采集（每秒收购，处理和显示34帧）。 FDA需要临床数据以支持II类设备的510（k）清除。为此，我们安排了与洛杉矶波士顿儿童医院Bascom Palmer Eye Institute的主要临床医生合作儿童医院，杜克大学眼中中心和威斯康星州医学院以获取图像通过预种族的新生儿，包括正常人，以及患有或怀疑痛苦的患者来自ROP或Plus疾病，视网膜退行性疾病或小儿青光眼。成像将在NICU中，在麻醉下进行检查，并在清醒的孩子身上。我们的期望是通过完全发达的多种模式，便携式掌上电脑退出II期计划成像系统为应得的，通常服务不足的人口提供新的护理标准。