Choroidal Blood Flow Imaging with Spectral Domain OCT

描述(申请人提供)：眼科血管疾病影响数百万美国人。老年性黄斑变性和糖尿病视网膜病变是众所周知的血管因素引起的两大疾病。血管系统在青光眼和早产儿视网膜病变中的作用更为隐蔽。青光眼的血管理论表明，眼睛的血液供应是青光眼的一个促成因素。晚期早产儿视网膜病变以血管曲折为特征，但对早产儿发育中血管的研究 早产儿和新生儿的眼睛还处于婴儿期。开发一种临床诊断方法来量化眼睛的两个不同循环系统(葡萄膜和视网膜)中的血流，对于这些眼部疾病的研究和鉴别诊断是至关重要的。Bioptigen一直走在儿科OCT的前沿，在2012年获得了第一个明确的儿科OCT FDA批准。2006年，在CWRU的独家许可下，Bioptigen还将第一个多普勒OCT软件商业化。目前的系统工作在800 nm波段，频率为32 kHz，限制了脉络膜结构和血流的可视化。Bioptigen公司开发的一种新的长波InGaAs线扫描相机和新的血流分析算法现在可以适用于一类新的光谱域OCT，用于成像视网膜和脉络膜的结构和血流。在这个第一阶段的应用中，我们建议开发一种工作在1020 nm的光谱域OCT系统，具有5 mm的图像深度，5微米的轴向分辨率，以及70 kHz的采集速度，用于包括脉络膜在内的全范围视网膜成像。Bioptigen的定量多普勒血流算法将进行准确性、精密度验证 和使用台式流量模组的最大可测量流量。将收集健康和青光眼成人受试者以及诊断为早产儿视网膜病变和非早产儿视网膜病变的婴儿的初步临床数据，以确定获得脉络膜和视网膜不同血管流速的能力，并区分青光眼和健康成人，ROP和健康新生儿。在第一阶段计划成功结束后，我们预计将准备设计一项方案和试点临床试验，以评估长波多普勒OCT对早产儿青光眼和视网膜病变的诊断能力。

DESCRIPTION (provided by applicant): Ophthalmic vascular diseases impact millions of Americans. Age-related macular degeneration and diabetic retinopathy are the two major diseases with a well- known vascular factor. The role of the vascular system in glaucoma and retinopathy of prematurity is more insidious. The vascular theory of glaucoma suggests that the blood supply to the eye is a contributory factor in glaucoma. Advanced retinopathy of prematurity is characterized vascular tortuosity, but the study of developmental vascularity in the pre-term and neonatal eye is in its infancy. The development of a clinical diagnostic to quantify blood flow in the two distinct circulatory systems of the eye (uveal and retinal) is essential to te research and differential diagnosis of these eye diseases. Bioptigen has been at the forefront of pediatric OCT, receiving the first explicit pediatric OCT FDA clearance in 2012. Bioptigen also commercialized the first Doppler OCT software in 2006, under exclusive license from CWRU. Current systems operate in the 800 nm band at 32 kHz, limiting visualization of structure and flow in the choroid. A new long-wave InGaAs line scan camera and novel blood flow analysis algorithms developed by Bioptigen can now be adapted to a new class of spectral domain OCT for imaging structure and flow in the retina and choroid. In this Phase I application we propose to develop a spectral domain OCT system operating at 1020 nm, with 5 mm image depth, 5 um axial resolution, and 70 kHz acquisition speed for full range retinal imaging including the choroid. Bioptigen's quantitative Doppler flow algorithms will be validated for accuracy, precision and maximum measureable flow rate using a benchtop flow phantom. Preliminary clinical data will be collected on healthy and glaucomatous adult subjects and on infants with and without diagnosed retinopathy of prematurity to determine ability to obtain differential vascular flow rate in choroid and retina, and to distinguish between glaucomatous and healthy adults, and ROP and healthy newborns. Upon successful conclusion of the Phase I program, we expect to be prepared to design a protocol and pilot clinical trial to assess the diagnostic capability of long wave Doppler OCT for glaucoma and retinopathy of prematurity.