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儿童眼病的预防和治疗是必要的，但由于从早产儿到大龄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注视，因此通常很难获得诊断图像。眼底摄影只能提供视网膜的二维表面图像，可能会遗漏有关疾病状态的信息。在这项二期小企业创新研究申请中，Bioptigen公司提出将手持式光谱域光学相干断层成像系统商业化，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方面有额外的应用。这个儿科和围手术期光谱域光学相干断层扫描系统（PP-SDOCT）是为了最大限度地方便使用而设计的，具有广泛的眼物理参数和疾病状态的非合作患者基础。该提案的目的是：通过角膜测距实现粗对准的快速图像采集，通过距离跟踪实现细对准，通过平滑调焦实现+ 12D校正而不影响对准，以及改进脚踏板控制以实现免提图像采集；捕获宽视场，高速，高分辨率的结构和功能视网膜图像；并临床验证新产品，为FDA 510(k)申请做准备。PP-SDOCT系统将具有宽视场光学（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需要临床数据来支持II类器械的510(k)许可。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、患有或疑似患有ROP或多发性疾病、视网膜退行性疾病或儿童青光眼的患者。成像将在新生儿重症监护病房进行，在麻醉下进行检查，并对清醒的儿童进行检查。我们的期望是在第二阶段项目结束时，拥有一个完全开发的、多模态的、便携式手持成像系统，为应得的、经常服务不足的人群提供新的护理标准。

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.