The broader/commercial impact of this Small Business Innovation Research (SBIR) Phase II Project continues from Phase I to realize a new surgical tool system to enable safe and precise delivery of stem cells and genes for ophthalmic application, specifically to repair and restore vision for patients with retinal degeneration. Visual impairment occurs in the natural course of aging, with some conditions potentially addressed surgically. Associated improvements in both quality of life and reduced health care expenditures can be addressed with a system involving augmented real-time visualization technology, tools capable of minute actions, and smart algorithms informing surgical actions. The proposed technology improves imaging by incorporating machine vision, with applications in ophthalmic treatment and beyond. This SBIR Phase II project will advance the development of an optical coherence tomography (OCT) guided sub-retinal injector system. Technical tasks include conducting studies to test clinical safety and procedure efficacy on both cadaveric human eyes and in-vivo porcine eyes. Specifically, trained surgeons will use the system to validate the capability to execute tasks related to subretinal microinjection procedures, determine the time to task completion, and characterize the magnitude and frequency of errors. The system will be validated with histology samples and compared to current the standard of care of freehand performance. Optimization and validation studies will take place to advance the translation of this technology. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
