SBIR Phase II: Novel, point-of-service device for use in diagnosing the severity of anterior eye injures with an objective measure of the ocular tear film

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve the quality of care for anterior ocular wounds. To accomplish this, the project is focused on the development of a novel, hand-held, point-of-care device that can be used to evaluate the ocular surface in post-trauma or post-surgical patients. The device should be able to provide an accurate, objective measurement of a tear film biomarker that can be used by medical professionals to identify dangerous fluid leaks in the front of the eye which can save vision. Currently, this evaluation is only performed by trained eye doctors and requires positioning the patient at an expensive, immobile machine called a slit lamp to evaluate their eye. This cannot be done on patients who are unconscious or uncooperative and availability of this machine is limited. The lack of adequate tools for evaluation results in limited access to care, costly hospital transfers and missed diagnosis of wound leaks which can cause severe ocular infections and permanent vision loss. Successful commercialization of this product is expected to improve the accuracy of ocular examinations in 3.8 million Americans annually and may introduce a new frontier of tear film testing. The proposed project is focused on developing the device for direct use for patient care. The technological aim of the research is on the creation of a sophisticated biosensor that can accurately and noninvasively evaluate the tear film concentration of a specific biomarker. This work is expected to include the development of the electrical circuitry, the chemical composition and the channels for connection to the base unit. The plan is to also design the model for the handheld device. In order to make the device safe for patient use, the device can then be tested for its shelf-life stability and develop the proper sterilization. The next steps of testing can include clinical patients to evaluate the ability of the device to record the findings from the tear film. This information can then be used to refine the exact testing parameters for the device. The anticipated result of this research is a final prototype of the device that can be used for regulatory approval and clinical trials. The goal of the project is to transform the current standard of care for eye professionals and enable physicians to have an objective measure that can warn them about possible wound leaks and potentially save vision.