A custom virtual reality training solution for ophthalmologic surgical clinical trials

We present a summary of the development and clinical use of two custom designed high-fidelity virtual-reality simulator training platforms. This simulator development program began in 2016 to support the phase III clinical trial Archway (ClinicalTrials.gov identifier, NCT03677934) intended to evaluate the Port Delivery System (PDS) developed by Genentech Inc. and has also been used to support additional clinical trials. The two simulators address two specific ophthalmic surgical procedures required for the successful use of PDS and provide state-of-the-art physical simulation models and graphics. The simulators incorporate customized active haptic feedback input devices that approximate different hand pieces including a custom hand piece specifically designed for PDS implantation. We further describe the specific challenges of the procedure and the development of corresponding training strategies realized within the simulation platform.