Research Project
8578136
DESCRIPTION (provided by applicant): In this Phase II Small Business Innovation Research application, Bioptigen, Inc. proposes to commercialize a deep imaging spectral domain optical coherence tomography (DI-SDOCT) imaging system that incorporates technology proven during the Phase I period to overcome traditional depth limits in OCT and has a maximum, artifact free imaging depth approaching 10 mm. This product will enable high-speed, high- resolution imaging of the cornea, iris, and anterior and posterior surfaces of the lens capsule that is unavailable in any other product to date. There is a proven market for perioperative OCT, and the outcome of this Phase II will be an OCT imaging product that extends the capabilities of current technology used in the clinic and enables full depth, high resolution anterior chamber imaging with OCT that can meet the exacting needs of the operating suite. Complex Conjugate Removal (CCR), the high risk element of the Phase I proposal, was successfully implemented, doubling the available imaging depth with suppression of DC noise, autocorrelation terms, and the complex conjugate artifact. This system is capable of imaging with <5 mm depth resolution over a 4.4 mm (depth) x 6 mm (lateral) imaging range with correction for refraction at the cornea, enabling accurate measurement of tissue microstructure and pathologies. Technical innovations proposed in the Phase II include spectrometer and probe optical design for extended depth imaging and falloff mitigation through a comb filter and are within the scope of Bioptigen's prior development experience. A subcontract with collaborators at the Bascom Palmer Eye Institute will enable external technology validation and human trials in first a clinical and then an intraoperative setting.
