Pediatric Spectral Domain Optical Coherence Tomography

描述（由申请人提供）：获取儿童视网膜的诊断图像对于预防和治疗儿童眼病是必要的，但由于从早产儿到年龄较大的儿童的眼睛形状和大小范围很大，并且在此范围内的大多数儿童无法固定，因此通常很困难。眼底照相术仅提供视网膜的二维表面图片，潜在地丢失关于疾病状态的信息。在这个第二阶段的小企业创新研究应用，Bioptigen，Inc。提出将手持式谱域光学相干断层扫描成像系统商业化，其目标是满足儿科患者群体的特定需求，并在围手术期成像和临床前成像中具有额外的应用。该儿科和围手术期谱域光学相干断层扫描系统（PP-SDOCT）设计用于最大程度地方便非合作患者群的使用，这些患者具有广泛的眼睛物理参数和疾病状态。该提案的目的是：通过角膜测距实现快速图像采集，用于粗略对准，范围跟踪用于精细对准，平滑焦点调节用于+12D校正而不影响对准，以及改进脚踏板控制用于免提图像采集;捕获宽视场、高速和高分辨率的结构和功能视网膜图像;并对新产品进行临床验证，为FDA 510（k）申报做准备。PP-SDOCT系统将设计有宽视场光学器件（80度）、高轴向分辨率（3.2 um）、高横向分辨率（6 um）、深成像窗口（3.2 mm）和高速采集（每秒34帧采集、处理和显示）。FDA要求临床数据支持II类器械的510（k）批准。为此，我们与巴斯科姆帕尔默眼科研究所、波士顿儿童医院、洛杉矶儿童医院、杜克大学眼科中心和威斯康星州医学院的主要临床医生合作，获取新生儿到青春期前的图像，包括正常人，以及患有或疑似患有ROP或视网膜变性疾病、视网膜变性疾病或小儿青光眼的患者。成像将在新生儿重症监护室进行，在麻醉状态下对清醒的儿童进行检查。我们的期望是退出第二阶段计划与一个完全开发的，多模态，便携式手持成像系统，提供了一个新的护理标准，值得，往往服务不足，人口。 公共卫生相关性：获取儿童视网膜的诊断图像对于预防和治疗儿童眼病是必要的，但由于从早产儿到年龄较大的儿童的眼睛形状和大小范围很大，并且在此范围内的大多数儿童在测试期间无法聚焦于成像目标，因此通常很困难。目前的成像方法只能提供视网膜的二维表面图像，可能会丢失有关疾病状态的信息。Bioptigen正在提议开发一种手持式医疗设备，即儿科和围手术期光谱域光学相干断层扫描（PP-SDOCT）成像系统，该系统将使摄影师能够快速无创地获取儿科眼睛的深度切片和血流信息，并可以极大地帮助儿科眼病的研究和治疗结果。

DESCRIPTION (provided by applicant): 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.