iCAP An Innovative Device to Rapidly Resolve Microbial Keratitis

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PROJECT SUMMARY Ulcerative keratitis caused by infectious microbes (bacteria, fungi, amoebae and viruses) represents a major area of medical concern. It is one of the most important causes of corneal opacifications, which is the second common cause of legal blindness world-wide after cataracts. In 2010, in the USA alone, 76.5% of the approximately 930,000 doctor’s office and outpatient clinic and 58,000 emergency department visits related to ocular distress and emergencies, resulted in antibiotic prescriptions for microbial keratitis. The total annual financial burden on our healthcare system for keratitis cases was estimated to be $175 million in direct health care expenditures in 2010 and was also estimated to consume over 250,000 annual hours of clinician time. Bacterial keratitis manifests as corneal ulcer, corneal edema and/or hypopyon and can cause significant complications including corneal perforation, corneal thinning, elevated intraocular pressure and progression to endophthalmitis. This could lead to severe clinical outcomes including partial or complete vision loss, necessity for penetrating keratoplasty, corneal grafts, enucleation and evisceration. Although topical and systemic antibiotics are effective in reducing microbial loads in keratitis cases (unless the microbe is resistant to the antibiotic utilized), the time required to resolve the infection is generally quite lengthy. Furthermore, antibiotics are typically ineffective in reducing inflammation and evoking regenerative repair of corneal and/or scleral defects and scarring which may be induced by the infection. In the preceding SBIR Phase I effort, Lynntech, Inc. in collaboration with the University of Mississippi Medical Center has obtained proof-of-concept for the potential clinical utility of an innovative, inexpensive and compact device, termed iCAP to effectively treat microbial keratitis at the point-of-diagnosis. We now propose this follow-on Phase II SBIR effort, where our specific aims are to (1) optimize and finalize iCAP device design, (2) comprehensively elucidate mechanisms of action of iCAP and (3) comprehensively demonstrate pre-clinical safety and efficacy of iCAP using relevant in vivo animal models of microbial keratitis and (4) research FDA requirements to enable IDE application and human trials in future phases of this effort. The successful completion of these specific aims should pave the way for FDA clearance and commercial insertion into ophthalmologic practice of affordable iCAP devices to effectively treat microbial keratitis at the point-of-diagnosis which in turn is likely to sustain high positive impact for the patient populace suffering from microbial keratitis.