Description:
OBJECTIVE: The objective of this effort is to develop and/or improve biocompatible materials for the mitigation and treatment of traumatic injuries, war-related injuries, and/or diseases to ocular structures and the visual system. DESCRIPTION: This SBIR topic seeks to develop and/or improve concepts for biocompatible materials for the restoration of vision following ocular trauma in military personnel. War-related ocular trauma has risen during the current conflicts due to technological advances including the use of improvised explosive devices (1). It is estimated that the rate of eye injuries relative to the overall injury rate in military personnel having served in Iraq and Afghanistan is approximately 13-16% (2). Thus, the military has placed an increased emphasis on restoring and rehabilitating injured Warfighters with functional capabilities that provide the ability to return the Warfighter to their duty performance, not just improve a patient"s ability to function in daily life with impairment. To meet this goal, effective biocompatible materials that enhance treatment and improve visual outcomes following injury are needed. Envisioned are biomaterials that allow for immediate stabilization of the eye following trauma, while also promoting ocular tissue repair, healing, and prevention of infection. The proposed treatment strategy should improve visual outcomes for patients having experienced ocular trauma. Highly novel approaches related to tissue adhesives for ophthalmic surgical applications for ocular trauma may also be considered. Further, improved ocular biomaterials for post-surgical application that incorporate drug delivery systems aimed to mitigate and treat inflammation, infection, and pain may also be considered. PHASE I: Define a conceptual approach for a technology and employing the technology that meets the intent of the SBIR topic for enhanced biocompatible materials for the repair of ocular injuries. Phase I deliverable: technical report that outlines the technology approach, establishes the feasibility of the approach using existing data and investigations conducted during Phase I, and a detailed analysis that defines the predicted performance of the end product. PHASE II: Assemble, test and deliver the prototype system(s) defined by the Phase 1 design. Quantifiable performance measures for the technology should be determined that are sufficient to assess the ability to provide an effective treatment. Conduct bench and animal studies in support of testing the technology in humans. Where feasible, conduct a pilot study in humans to assess initial safety and effectiveness of the technology. Develop a plan and cost/time estimate for additional development and clinical study activities required to achieve the FDA and other regulatory approvals required to make the technology commercially available for military clinical use. Phase II deliverables include: prototype system, technical reports documenting the appropriate performance measures for the technology, bench and animal studies conducted, and the pilot clinical study; and a roadmap report that addresses the additional activities and the cost and time required to make the technology commercially available. PHASE III: Technology innovations developed through this SBIR would also have dual use application for vision restoration in the military and civilian sectors. The technologies would provide for significantly improved capabilities that could also reduce the impact (cost, workload, etc) of providing associated clinical services both in military and non-military settings. REFERENCES: 1. Radomski MV, Davidson L, Voydetich, Erickson MW. Occupational therapy for service members with mild traumatic brain injury. Am J Occup Ther. 2009;4:646-655. 2. Weichel ED, Colyer MH, Ludlow SE, Bower KS, Eiseman AS (2008). Combat ocular trauma visual outcomes during Operations Iraqi and Enduring Freedom. Ophthalmology, 115(12):2235-45.
