Pediatric Spectral Domain Optical Coherence Tomography

儿科谱域光学相干断层扫描

• 批准号: 8838894
• 负责人: Eric L. Buckland
• 金额: $ 9.95万
• 依托单位: BIOPTIGEN, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-05-01 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8838894
• 关键词: Adolescent; Adult; Affect; Algorithms; Anesthesia procedures; Architecture; Blood flow; Boston; Child; Childhood; Clinic; Clinical; Clinical Data; Collaborations; Computer software; Cornea; Databases; Development; Devices; Diagnostic Imaging; Disease; Electromagnetics; Eye; Eye diseases; Feedback; Fluorescein; Fluorescein Angiography; Fluorescence; Functional Imaging; Fundus; Fundus photography; Glaucoma; Hand; Image; Image Analysis; Infant; Institutes; Lateral; Length; Location; Los Angeles; Medical Device; Modality; Modification; Operative Surgical Procedures; Optical Coherence Tomography; Optics; Pathology; Patients; Pediatric Hospitals; Perioperative; Phase; Population; Posture; Preparation; Prevention; Process; Research; Resolution; Retina; Retinal; Retinal Degeneration; Retinal Diseases; Safety; Shapes; Site; Slice; Small Business Innovation Research Grant; Speed; Surface; System; Testing; Time; Treatment outcome; Underserved Population; Universities; Validation; Visual; Wisconsin; arm; awake; base; commercialization; design; expectation; eye center; fluorescence imaging; imaging modality; improved; medical schools; meetings; neonate; operation; optical imaging; patient population; portability; pre-clinical; programs; prototype; sample fixation; standard of care; tool; two-dimensional

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.

项目概要 获取儿童视网膜的诊断图像对于预防和治疗儿科疾病至关重要 眼部疾病，但由于从早产儿到老年，眼睛的形状和大小差异很大，因此通常很困难 儿童以及该范围内的大多数儿童无法注视。眼底摄影仅提供两种 视网膜的三维表面图像，可能缺少有关疾病状态的信息。 在此第二阶段小型企业创新研究应用中，Bioptigen, Inc. 提议将 手持式谱域光学相干断层扫描成像系统有针对性地满足特定需求 儿科患者群体，并在围手术期成像和临床前成像中具有其他应用。 该儿科和围手术期谱域光学相干断层扫描系统 (PP-SDOCT) 是 专为具有广泛肉眼的非合作患者群提供最大程度的易用性而设计 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，以进行粗略的 对准、范围跟踪进行精细对准、平滑对焦调整以进行 + 12D 校正而不影响 对准和改进的脚踏板控制，用于免提图像采集；捕捉宽视场、高 速度、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 准备 FDA 510(k) 提交。 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 需要临床数据来支持 II 类器械的 510(k) 许可。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获取图像 新生儿到青春期前的儿童，包括正常人以及患有或疑似患有该病的患者 来自 ROP 或附加疾病、视网膜退行性疾病或小儿青光眼。影像检查将在 NICU 进行， 检查——在麻醉下，对清醒的孩子进行。 我们的期望是通过完全开发的、多模态、便携式手持设备退出第二阶段计划 成像系统为应得的、往往服务不足的人群提供新的护理标准。