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

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是提高眼前伤口的护理质量。为了实现这一目标，该项目专注于开发一种新颖的、手持的、即时护理的设备，用于评估创伤后或术后患者的眼表。该设备应该能够提供准确、客观的泪膜生物标志物测量，医疗专业人员可以使用它来识别眼睛前部的危险液体泄漏，从而挽救视力。目前，这种评估只能由训练有素的眼科医生进行，并且需要将患者安置在一个昂贵的、不可移动的被称为裂隙灯的机器前来评估他们的眼睛。这不能在无意识或不合作的病人身上完成，而且这种机器的可用性是有限的。缺乏适当的评估工具，导致获得护理的机会有限，医院转诊费用高昂，以及对可能导致严重眼部感染和永久性视力丧失的伤口泄漏的漏诊。该产品的成功商业化有望提高每年380万美国人眼科检查的准确性，并可能引入泪膜测试的新前沿。拟议项目的重点是开发直接用于患者护理的设备。这项研究的技术目标是创造一种复杂的生物传感器，可以准确和无创地评估特定生物标志物的泪膜浓度。这项工作预计将包括开发电路、化学成分和连接到基本单元的通道。该计划还将为手持设备设计模型。为了使设备对患者安全使用，然后可以测试设备的保质期稳定性并开发适当的灭菌。接下来的测试步骤包括临床患者评估该设备记录泪膜结果的能力。这些信息可用于细化设备的确切测试参数。这项研究的预期结果是该设备的最终原型，可用于监管批准和临床试验。该项目的目标是改变目前眼科专业人员的护理标准，使医生能够有一个客观的措施，可以警告他们可能的伤口泄漏，并可能挽救视力。

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.