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.

Public Health Relevance

Spectral Domain Optical Coherence Tomography (SDOCT) is a non-invasive, high resolution optical imaging method that is often used in ophthalmic applications to better understand or diagnose disease. There are currently no SDOCT products that target the surgical market, but the ability to rapidly image the eye during surgery could greatly improve the outcome of the surgery and limit patient risk. This proposal seeks to extend the utility of SDOCT by providing a device capable of imaging the cornea, iris, and both surfaces of the lens that can be used in the clinic and in the surgical suite. This product will provide a much longer imaging depth range than any commercial SDOCT product on the market. This could greatly aid in the research of diseases whose pathology manifests as structures larger than the maximum depth range of traditional SDOCT systems. An immediate application would be monitoring the eye before, during, and after cataract or glaucoma surgery to ensure the surgery is successful.

National Institute of Health (NIH)
National Eye Institute (NEI)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1-ETTN-E (12))
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Wujek, Jerome R
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Bioptigen, Inc.
United States
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