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.

摘要 青光眼是全球成人失明的主要原因之一。没有一种单一的工具可以 在需要多种方法组合的所有情况下诊断青光眼，包括标准自动视野检查， 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、眼内压（IOP）和眼底照相以评估杯盘比。RNFL的变化 在高度近视的个体中以及在先前已经 用激光治疗眼睛。来自后段的眼血流（OBF）信息，如通过眼内超声获得的。 我们开发的FDA批准的XyCAM RI仪器有可能增加与青光眼相关的见解 这是对传统方法补充。我们的初步结果表明， 青光眼患者和健康对照者视盘和黄斑区OBF模式的差异。我们 目前的第二阶段项目旨在验证由XyCAM RI获得的OBF指标的诊断潜力 通过严格的年龄匹配、种族匹配和性别匹配的临床研究， 对照，并特别证明OBF衍生的测量在青光眼评估中的有用性 高度近视的患者。我们还寻求开发和推向市场的增强型多功能眼底 XyCAM FC用于临床。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盘比以及OBF信息，包括最具诊断相关性的 功能.作为一项前沿技术，它补充了彩色眼底图像与视频数据的OBF动态， 高时间分辨率，XyCAM FC提供了执行眼底可报销程序的能力， 照相，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 研究开发基于OBF的眼科和全身病理学生物标志物， 眼部脉管系统