Transaction Description:
IN VIVO HIGH-DEFINITION 3D CORNEAL IMAGING - THE CORNEA, THE OUTERMOST WINDOW OF OUR VISUAL SYSTEM, IS VULNERABLE TO VARIOUS TYPES OF INFECTIONS AND DISEASES. CORNEAL DISEASE IS ONE OF THE LEADING CAUSES OF VISUAL DEFICIENCY AND BLINDNESS, AND IS CONSIDERED THE SECOND MAJOR CAUSE OF BLINDNESS IN DEVELOPING COUNTRIES. THERE ARE NEARLY 5 MILLION BILATERALLY CORNEAL BLIND PERSONS WORLDWIDE, AND AN ESTIMATED 23 MILLION PEOPLE AFFECTED BY UNILATERAL CORNEAL BLINDNESS GLOBALLY. IN A CONSERVATIVE ESTIMATE, CORNEAL DISEASES AFFECT NEARLY 300,000 PEOPLE IN THE UNITED STATES, WITH FUCHS’ DYSTROPHY AFFECTING 4% OF PEOPLE AGED OVER 40. GIVEN THE LARGE PREVALENCE OF CORNEAL DISEASE AND THE NEAR-IMPOSSIBILITY OF PERFORMING BIOPSY, HIGH-DEFINITION CORNEAL IMAGING IS NEEDED TO ASSIST CLINICAL DIAGNOSIS, EVALUATE PROGRESSION OF DISEASES, AND TREATMENT. ADDITIONALLY, THE CORNEA IS THE MOST COMMONLY TRANSPLANTED TISSUE WORLDWIDE. GABOR-DOMAIN OPTICAL COHERENCE MICROSCOPY (GDOCM) IS A HIGH-RESOLUTION, NON-INVASIVE IMAGING TECHNOLOGY THAT CAN VISUALIZE MICROSCOPIC STRUCTURES IN VIVO IN 3D. PRELIMINARY DATA SUGGEST THAT GDOCM HAS THE FOLLOWING KEY ADVANTAGES OVER EXISTING CORNEAL IMAGING TECHNIQUES, WHICH INCLUDE SPECULAR AND CONFOCAL MICROSCOPY: 1) 10-100X INCREASE IN FIELD OF VIEW – THIS WILL LEAD TO MORE ACCURATE QUALIFICATION OF THE CORNEAL TISSUE, SINCE A LARGER AREA CAN BE ASSESSED; 2) SIMULTANEOUS MEASURE OF CORNEAL THICKNESS, QUANTIFICATION OF ENDOTHELIAL CELL DENSITY, AS WELL AS IDENTIFICATION OF MORPHOLOGICAL VARIATIONS DUE TO CORNEAL DISEASE – THIS WILL LEAD TO FULL CORNEAL EVALUATION IN ONE INSTRUMENT; 3) 3D IMAGING CAPABILITY AT THE CELLULAR LEVEL OF THE MOSAIC OF TRANSLUCENT CORNEAL CELLS – THIS WILL ENABLE A DETAILED UNDERSTANDING THE VOLUMETRIC PROGRESSION OF THE DISEASES. WE HAVE ASSEMBLED AN EXCEPTIONALLY STRONG TEAM OF CLINICAL INVESTIGATORS TO COLLABORATE ON THIS PROPOSAL, AND WITH THEIR HELP WE HAVE IDENTIFIED FOUR USE CASES FOR CLINICAL APPLICATION OF OUR DUAL-IMAGING TECHNOLOGY TO IMAGE THE CORNEA WITH VOLUMETRIC CELLULAR-RESOLUTION. WE ENVISION THAT IN THE FUTURE THE DUAL OCT (OPTICAL COHERENCE TOMOGRAPHY) AND GDOCM INSTRUMENT ENABLED BY THIS PHASE II SBIR PROPOSAL WILL PROVIDE AN IMAGE-GUIDANCE METHOD TO ASSIST CLINICIANS IN THE ASSESSMENT AND TREATMENT OF CORNEAL DISEASES AND OTHER DISEASES AFFECTING THE ANTERIOR SEGMENT OF THE EYE, INCLUDING DIABETES AND GLAUCOMA.
