Ocular Blood Flow Imaging for Glaucoma Assessment

用于青光眼评估的眼血流成像

• 批准号: 10617379
• 负责人: Abhishek Rege
• 金额: $ 87.5万
• 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 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10617379
• 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; Marketing; 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; Specific qualifier value; Symptoms; Technology; Testing; Thick; Thinness; Vision; Visualization; blood flow measurement; candidate marker; clinically relevant; commercialization; data acquisition; data management; design; early detection biomarkers; frontier; fundus imaging; health goals; human old age (65+); imager; imaging capabilities; indexing; innovation; insight; instrument; macula; multimodality; neurovascular; ocular imaging; optical disc; 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 青光眼是全世界成年人失明的主要原因之一。没有任何一种仪器可以 在所有需要结合使用标准自动视野检查等方法的情况下诊断青光眼 评估周边视力，光学相干断层扫描（OCT）评估视网膜神经纤维层（RNFL） 变薄、眼压 (IOP) 和眼底照相来评估视杯与视盘的比例。 RNFL 的变化是 对于高度近视的个体以及之前患有近视的患者进行评估具有挑战性 用激光治疗眼睛。来自后段的眼部血流 (OBF) 信息，通过 我们开发的经 FDA 批准的名为 XyCAM RI 的仪器有可能增加与青光眼相关的见解 是对传统方法的补充。我们的初步结果表明 青光眼受试者和健康对照者视盘和黄斑区域 OBF 模式的差异。我们的 目前的第二阶段项目旨在验证 XyCAM RI 获得的 OBF 指标的诊断潜力 通过年龄匹配、种族匹配和性别匹配的严格临床研究来管理青光眼 对照，并具体证明 OBF 衍生测量在青光眼评估中的有用性 在高度近视患者中。我们还寻求开发增强型多功能眼底并将其推向市场 称为 XyCAM FC 的临床用途相机。 XyCAM FC 将允许医生可视化眼底照片 在立体模式下评估杯盘比以及 OBF 信息，包括与诊断最相关的信息 特征。作为一项前沿技术，以 OBF 动态视频数据补充彩色眼底图像 高时间分辨率，XyCAM FC 能够执行可报销的眼底手术 摄影，使眼科医生或验光师能够可视化青光眼病理生理学，并进行 基于 OBF 的眼科和全身病理学生物标志物的开发研究 眼部血管系统。