Pediatric Spectral Domain Optical Coherence Tomography

儿科谱域光学相干断层扫描

• 批准号: 8129075
• 负责人: Bradley A. Bower
• 金额: $ 36.67万
• 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 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8129075
• 关键词: Adolescent; Adult; Affect; Algorithms; Anesthesia procedures; Architecture; Blood flow; Boston; Child; Childhood; Clinic; Clinical; Clinical Data; Collaborations; Computer software; Cornea; Databases; Degenerative Disorder; 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

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.

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小儿眼病是必要的，但由于从早产儿到较大儿童的眼睛形状和大小范围很大，并且大多数儿童在该范围内无法注视，因此通常很困难。眼底摄影仅提供视网膜的二维表面图像，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商业化，旨在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进行其他应用。这款儿科和围手术期谱域光学相干断层扫描系统 (PP-SDOCT) 专为具有各种眼部物理参数和疾病状态的非合作患者群体提供最大程度的易用性而设计。该提案的目标是：通过用于粗对准的角膜测距、用于精细对准的范围跟踪、用于 + 12D 校正的平滑焦点调整而不影响对准以及改进脚踏板控制以实现免提图像采集，从而实现快速图像采集；捕捉宽视场、高速、高分辨率的结构和功能性视网膜图像；并对新产品进行临床验证，为 FDA 510(k) 提交做准备。 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，我们安排与 Bascom Palmer 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，获取新生儿至青春期前儿童的图像，包括正常人以及患有或疑似患有 ROP 或以上疾病、视网膜退行性疾病或小儿青光眼的患者。影像检查将在新生儿重症监护病房（NICU）、麻醉下以及清醒的儿童身上进行。我们的期望是通过完全开发的、多模态、便携式手持成像系统退出第二阶段项目，为应得的、往往服务不足的人群提供新的护理标准。 公共健康相关性：获取儿童视网膜的诊断图像对于预防和治疗儿科眼病是必要的，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，而且大多数儿童在测试期间无法在该范围内聚焦于成像目标，因此这通常很困难。目前的成像方法仅提供视网膜的二维表面图像，可能缺少有关疾病状态的信息。 Bioptigen 正在提议开发一种手持式医疗设备，即儿科和围手术期谱域光学相干断层扫描 (PP-SDOCT) 成像系统，该系统将使摄影师能够快速无创地获取儿科眼部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。