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 thepre-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, precisionand 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.
Thesaurus Terms: Adult;Age Related Macular Degeneration;Algorithmic Software;Algorithms;American;Base;Blood Flow;Blood Vessels;Cardiovascular System;Childhood;Choroid;Clinical;Clinical Data;Clinical Trials;Computer Software;Data;Design;Development;Diabetic Retinopathy;Diagnosis;Diagnostic;Differential Diagnosis;Disease;Early Diagnosis;Engineering;Eye;Eye Diseases;Glaucoma;Image;Imagery;Imaging Phantoms;Improved;Infancy;Infant;Laser-Doppler Velocimetry;Licensing;Magnetic Resonance Imaging;Measurement;Measures;Metric;Neonatal;Newborn Infant;Novel;Operating System;Optical Coherence Tomography;Optics;Perfusion;Phase;Process;Programs;Protocols Documentation;Public Health Relevance;Relative (Related Person);Research;Resolution;Retina;Retinal;Retinopathy Of Prematurity;Role;Scanning;Speed (Motion);Statistics;Structure;System;Testing;Theories;Ultrasonography;Vascular Blood Supply;Vascular Diseases;Vascular Factor;Vascular System;Vision;
