Pediatric Spectral Domain Optical Coherence Tomography

项目摘要 获取儿童视网膜的诊断图像对于预防和治疗儿童视网膜病变是必要的。 眼睛疾病，但它往往是困难的，由于大范围的眼睛形状和大小，从早产儿到老年人 在这个范围内的大多数儿童无法注视。眼底照相只能提供两个- 视网膜的三维表面图像，可能丢失有关疾病状态的信息。 在这个第二阶段的小企业创新研究应用，Bioptigen，Inc。建议将一个 手持式谱域光学相干层析成像系统的针对性，以满足特定的需求 儿科患者群体，以及围手术期成像和临床前成像的其他应用。 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使用， 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， 对准，范围跟踪，用于精细对准，平滑对焦调整，用于+12D校正，而不影响 校准和改进的脚踏板控制，用于免提图像采集;捕获宽视场，高分辨率， 快速，高分辨率的结构和功能视网膜图像;并在临床上验证新产品， FDA 510（k）申报的准备工作。PP-SDOCT系统将被设计为具有宽视场 光学系统（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帧的采集、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，我们安排了 与洛杉矶波士顿儿童医院巴斯科姆帕尔默眼科研究所的主要临床医生合作 儿童医院、杜克大学眼科中心和威斯康星州医学院， 新生儿至青春期前，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。影像室会在新生儿重症监护室 在麻醉下和清醒的儿童身上进行检查。 我们的期望是通过一款完全开发的多模态便携式手持设备退出第二阶段计划 成像系统，提供了一个新的标准照顾值得，往往服务不足，人口。

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.