Pediatric Spectral Domain Optical Coherence Tomography

描述(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，以及这一范围内的大多数儿童无法凝视，因此获取诊断图像通常是困难的。眼底照相只提供了视网膜的二维表面图像，可能会遗漏有关疾病状态的信息。在第二阶段的小企业创新研究应用中，Bioptigen公司提议将手持光谱域光学相干断层扫描成像系统商业化，以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进行更多应用。这款儿科和围手术期光谱域光学相干断层扫描系统(PP-SDOCT)旨在最大限度地方便非合作患者群的使用，具有广泛的物理眼睛参数和疾病状态。该建议的目标是：通过角膜测距实现粗对准的快速图像采集，通过范围跟踪实现精细对准，在不影响对准的情况下实现+12D校正的平滑焦点调整，以及针对免提图像采集改进的踏板控制；捕获大视场、高速和高分辨率的结构和功能视网膜图像；以及临床验证新产品，为FDA 510(K)提交做准备。PP-SDOCT系统将设计具有宽视场光学(80度)、高轴向分辨率(3.2微米)、高横向分辨率(6微米)、深成像窗口(3.2毫米)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类设备的510(K)许可。为此，我们安排了与巴斯科姆·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医学院的领先临床医生合作，通过青少年前儿童(包括正常人)以及患有或怀疑患有ROP或PLUS疾病、视网膜退行性疾病或儿童青光眼的患者获取新生儿的图像。成像将在NICU进行检查-麻醉下，以及清醒的儿童。我们的期望是退出第二阶段计划，拥有一种完全开发的、多模式的便携式成像系统，为应得的、往往得不到充分服务的人群提供新的护理标准。 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，以及在此范围内的大多数儿童在测试过程中无法聚焦于成像目标，因此获取诊断图像通常是困难的。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医疗设备，即儿科和围手术期光谱域光学相干断层成像(PP-SDOCT)成像系统，该系统将使摄影师能够快速非侵入性地获取儿科眼睛的深度切片和血流信息，并可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.