Pediatric Spectral Domain Optical Coherence Tomography

项目摘要 获取儿童视网膜的诊断图像是预防和治疗儿童视网膜病变的必要手段 眼科疾病，但通常是困难的，因为眼睛的形状和大小范围很大，从早产儿到老年人 儿童和这一范围内的大多数儿童无法凝视。眼底照相只提供了两个- 视网膜的三维表面图像，可能会遗漏有关疾病状态的信息。 在这一第二阶段的小企业创新研究应用中，Bioptigen，Inc.提议将一种 针对特定需求的手持光谱域光学相干层析成像系统 以及在围手术期成像和临床前成像中的其他应用。 这套儿科和围手术期光谱域光学相干断层扫描系统(PP-SDOCT)是 旨在最大限度地方便使用非合作的患者群，具有广泛的肉眼 参数和疾病状态。 该建议的目的是：通过角膜测距实现粗略的快速图像采集 对准、范围跟踪以实现精细对准、平滑调焦以进行12D校正而不会影响 自动对准和改进的脚踏板控制，可实现免提图像采集；捕捉大视场、高分辨率 速度和高分辨率的结构和功能的视网膜图像；并在临床上验证新产品 为FDA 510(K)提交做准备。PP-SDOCT系统的设计将具有广阔的视野 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 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类设备的510(K)许可。为此，我们已经安排了 与洛杉矶波士顿儿童医院巴斯科姆·帕尔默眼科研究所的领先临床医生合作 儿童医院、杜克大学眼科中心和威斯康星医学院 通过青春期前的新生儿，包括正常人和患有或怀疑患有疾病的患者 由ROP或PLUS疾病、视网膜退行性疾病或儿童青光眼引起。成像将在NICU进行， 检查-在麻醉下，对清醒的儿童进行检查。 我们的期望是退出第二阶段计划，拥有一款完全开发的、多模式的便携式手持设备 成像系统，为理应得到、但往往得不到充分服务的人群提供新的护理标准。

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.