SBIR-STTR Award

In this Phase I Small Business Innovative Research application, Bioptigen Inc. proposes to prototype a portable, handheld cornea and anterior segment optical coherence tomography (CAS-OCT) scanner for use in clinical and applied research applications. OCT is a relatively new technology for ophthalmic imaging, which uses low-coherence interferometry to obtain cross-sectional images in living tissues with micron-scale resolution noninvasively. OCT systems based on the original time-domain interferometry technology have been successfully demonstrated for human retinal and anterior segment imaging at 830nm and 1300nm wavelengths, respectively, however the slower image acquisition rate and lower signal-to-noise ratio of the older technology places severe constraints on the range of subjects which can be successfully imaged. In order to immobilize patients for long acquisition times, retinal and anterior segment OCT imagers commercialized to date have been built into standard tabletop slit-lamp biomicroscope designs. The resulting systems are bulky and limit the range of potential subjects to cooperative humans who can sit upright and fixate well for several seconds. In the last few years, Fourier domain OCT (FDOCT) technology has emerged as a superior alternative to time-domain OCT, exhibiting improved image acquisition speed and robust system design. The increased image acquisition speed opens the possibility for the first time for ophthalmic OCT imaging with handheld probes, and the robust design potential of FDOCT enables the implementation of truly portable systems. Bioptigen, Inc., a startup company affiliated with Duke University, has marketed state-of-the- art retinal FDOCT systems operating at 830nm wavelength using both conventional and handheld delivery optics, and also markets a tabletop microscope-based 1300nm wavelength OCT system for small animal imaging and other pre-clinical research applications. However, due to a limitation intrinsic to FDOCT, both of these systems are limited in imaging depth to less than 4 millimeters, which is insufficient for full-depth anterior segment imaging. In this SBIR Phase I proposal, Bioptigen proposes to adapt their 1300nm OCT and handheld probe technology for high speed, handheld, full-depth anterior segment imaging which will make the benefits of ophthalmic OCT imaging available to a much wider class of subjects, including bedridden and infant human patients, as well as animals of all sizes (from mouse to horse) used in biomedical and veterinary research. In this Phase I Small Business Innovative Research application, Bioptigen Inc. proposes to prototype a portable, handheld cornea and anterior segment optical coherence tomography (CAS-OCT) scanner for use in clinical and applied research applications. This imaging system will be able to image the full depth of the anterior segment (> 6mm) by developing a novel approach to complex conjugate artifact removal.

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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.

Thesaurus Terms:
"abscission; Anterior; Anterior Chamber; Anterior Chamber Of The Eye; Anterior Chamber Of Eye Structure; Artifacts; Biometrics; Biometry; Biometry And Biostatistics; Biostatistics; Body Tissues; Cataract; Clinic; Clinical; Comb Animal Structure; Combs; Complex; Computer Programs; Computer Software; Cornea; Development; Devices; Disease; Disorder; Doppler Oct; Elements; Ensure; Evaluation; Excision; Extirpation; Eye; Eyeball; Government; Human; Human, General; Image; Institutes; Iris; Iris (Eye); Lateral; Lens Capsule; Man (Taxonomy); Man, Modern; Marketing; Measurement; Modification; Monitor; Morphologic Artifacts; Noise; Oct Tomography; Operation; Operative Procedures; Operative Surgical Procedures; Optical Coherence Tomography; Optics; Outcome; Pathology; Patients; Perioperative; Persons; Phase; Refractive Indices; Removal; Research; Resolution; Risk; Sbir; Sbirs (R43/44); Safety; Sampling; Small Business Innovation Research; Small Business Innovation Research Grant; Software; Source; Speed; Speed (Motion); Structure; Structure Of Lens Capsule; Surface; Surgical; Surgical Interventions; Surgical Procedure; Surgical Removal; System; System, Loinc Axis 4; Technology; Testing; Tissues; Tomography, Optical Coherence; Validation; Anterior Chamber; Cataractogenesis; Cataractous Lenses; Computer Program/Software; Corneal; Design; Designing; Disease Diagnosis; Disease/Disorder; Experience; Glaucoma Surgery; High Risk; Imaging; Imaging Modality; Improved; Innovate; Innovation; Innovative; Lens; Lens Capsule; Meetings; Optic Imaging; Optical Imaging; Public Health Relevance; Resection; Statistics/Biometry; Surgery; Technology Validation"