Choroidal Blood Flow Imaging with Spectral Domain OCT

描述（由申请人提供）：眼部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两种主要的血管性疾病。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进因素。晚期早产儿视网膜病变以血管扭曲为特征，但对发育性视网膜病变的研究较少

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.