SBIR Phase I: 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 of this Small Business Innovation Research (SBIR) Phase I project is a paradigm shift in the initial evaluation and triage of anterior corneal injuries, through the development of a new medical device that can be used to evaluate a patient with an eye trauma. There are 2.4 million eye injuries per year in the United States. The most serious eye injury is called an open globe injury. The incidence of open globes has been reported to be between 2-6 per 100,000 in adults and 15.2 per 100,000 in children. Accurate diagnosis and timely management are critical for visual recovery. Making the correct diagnosis on these patents is very challenging and first responders have very little tools available to them. If suspicion for ruptured globe exists, the patients are transferred to a tertiary care center in order to have access to an on-call eye doctor. This inefficient, multi-referral approach is very costly to our health care system and delays proper care. The United States spends $6.6 million dollars each year on open globes injuries. Access to a reliable, accurate, hand-held, biosensor system can solve this problem by providing non-ophthalmologists with a objective tool to improve diagnosis in order to initiate the proper management for eye traumas which could save vision. The proposed project will validate this biosensor in the evaluation of eye injuries. 6.8-14.7% of ocular traumas that present to the emergency department are from anterior injuries. This biosensor uses a sophisticated nanotechnology-based approach through an enzyme-loaded gold plated electrode within sensing paper that can be inserted in the ocular tear film of patients with eye trauma to obtain immediate results on the degree of injury. The scope of this study is to maximize the sensitivity of the biosensor test strips by optimizing the base material of the sensor. The current configuration of the proposed system is deposited on paper, and the team will move to glass or silica as a base layer to improve the sensitivity of the device. Next, the team will study the variable polymer coatings and their effect in robust detection of small fluid volumes to optimize reproducibility. Testing will be on samples of collected ocular fluid. From their preliminary work, the team anticipates achieving accurate results with sensitivity of greater than 90%. The impact of this device is a paradigm shift in the initial evaluation and triage of anterior corneal injuries. This prevents unnecessary high-level specialty consultation and uses technology advancements to provide better care with lower cost approaches.