Ocular Blood Flow Imaging for Glaucoma Assessment

用于青光眼评估的眼血流成像

• 批准号: 10483638
• 负责人: Abhishek Rege
• 金额: $ 67.49万
• 依托单位: VASOPTIC MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-03 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10483638
• 关键词: Adult; Age; Angiography; Axon; Biological Markers; Blindness; Blood Vessels; Blood flow; Cardiac; Clinic; Clinical; Clinical Research; Color; Complement; Computer software; Cornea; Data; Data Storage and Retrieval; Diagnosis; Diagnostic; Eye; Eye Development; Functional Imaging; Functional disorder; Fundus; Fundus photography; Glaucoma; Homeostasis; Hyperoxia; Image; Imaging Device; Impairment; Individual; Inhalation; Laser Speckle Imaging; Lasers; Lighting; Measurement; Methods; Monitor; Morphology; Myopia; Ophthalmologist; Ophthalmology; Optic Disk; Optical Coherence Tomography; Optics; Optometrist; Optometry; Outcome; Oxygen; Pathology; Patients; Pattern; Performance; Perfusion; Perimetry; Peripheral; Phase; Physiologic Intraocular Pressure; Primary Open Angle Glaucoma; Procedures; Process; Public Health; Race; Reporting; Research; Resolution; Retina; Retinal Ganglion Cells; Safety; Secure; Sensitivity and Specificity; Symptoms; Technology; Testing; Thick; Thinness; Vision; Visualization; base; blood flow measurement; candidate marker; clinically relevant; data acquisition; data management; design; early detection biomarkers; frontier; fundus imaging; health goals; imager; imaging capabilities; indexing; innovation; insight; instrument; macula; multimodality; neurovascular; ocular imaging; optical imaging; perfusion imaging; prototype; recruit; retinal damage; retinal nerve fiber layer; safety testing; sex; temporal measurement

ABSTRACT Glaucoma is one of the leading causes of blindness in adults worldwide. There is no single instrument that can diagnose glaucoma in all cases requiring a combination of methods including standard automated perimetry to assess peripheral vision, optical coherence tomography (OCT) to assess retinal nerve fiber layer (RNFL) thinning, intraocular pressure (IOP), and fundus photography to assess the cup to disc ratio. RNFL changes are challenging to assess in individuals with a high degree of myopia as well as in patients that have previously been treated with laser in the eye. Ocular blood flow (OBF) information from posterior segment, as obtained by an FDA-cleared instrument called XyCAM RI developed by us, has the potential to add insights relevant to glaucoma status that are complementary to conventional methods. Our preliminary results have demonstrated significant differences in OBF patterns in the optic disc and macular regions in glaucoma subjects and healthy controls. Our present Phase II project seeks to validate the diagnostic potential of OBF metrics obtained by XyCAM RI in the management of glaucoma through a rigorous clinical study with age-matched, race-matched, and sex-matched controls, and specifically demonstrate the usefulness of OBF-derived measurements in assessment of glaucoma in highly myopic patients. We also seek to develop and bring to market an enhanced multi-function fundus camera called the XyCAM FC for clinical use. The XyCAM FC will permit practitioners to visualize fundus photos in stereo mode to assess cup-to-disc ratio and also OBF information including the most diagnostically relevant features. As a frontier technology that complements color fundus images with video data on OBF dynamics at a high temporal resolution, the XyCAM FC offers the ability to perform reimbursable procedures of fundus photography, enable an ophthalmologist or optometrist to visualize glaucoma pathophysiology, and conduct research on development of OBF-based biomarkers for ophthalmic and systemic pathology with symptoms in the ocular vasculature.

抽象的 青光眼是全球成人失明的主要原因之一。没有一个可以 在所有情况下，诊断青光眼需要组合，包括标准自动围场在内的方法 评估外围视觉，光学相干断层扫描（OCT）以评估视网膜神经纤维层（RNFL） 稀疏，眼内压（IOP）和眼底摄影，以评估杯子与圆盘比。 RNFL更改是 在高度近视和以前的患者中评估的人挑战 用激光在眼中治疗。从后段的眼血流（OBF）信息，如 我们开发的称为Xycam RI的FDA清理仪器有可能增加与青光眼相关的见解 与常规方法互补的状态。我们的初步结果表明 青光眼受试者和健康对照中的视盘和黄斑区域的OBF模式的差异。我们的 目前的II期项目旨在验证Xycam RI获得的OBF指标的诊断潜力 通过严格的临床研究对青光眼进行管理，并与年龄匹配，比赛匹配和性别匹配 对照，并专门证明了OBF衍生测量在评估青光眼评估中的有用性 在高度近视的患者中。我们还寻求开发并引入增强的多功能底面 摄像机称为Xycam FC用于临床使用。 Xycam FC将允许从业者可视化眼底照片 在立体声模式下评估杯赛比率，以及包括最相关的最相关的信息 特征。作为一种边境技术，可以通过有关OBF动力学的视频数据补充彩色底面图像 XYCAM FC高度分辨率高，提供了执行可偿还的基础程序的能力 摄影，使眼科医生或验光师能够可视化青光眼的病理生理学并进行 研究基于OBF的生物标志物用于眼科和系统病理学的生物标志物，并具有症状 眼脉管系统。