Researchers based in Germany and California have reported an innovative procedure for a “Port Delivery System” with ranibizumab (PDS), using a drug delivery system for continuous delivery of a customized formulation into the vitreous. The implant is inserted through the pars plana, and the medication is subsequently refilled in an office-based procedure. A Phase 2 trial used the PDS with 3 customized ranibizumab formulations with a 100 mg/mL insertion with a fixed 24-week refill for neovascular AMD patients. The device is then compared with monthly intravitreal ranibizumab 0.5 mg in a Phase 3. The implant will be refilled with “a specialized needle that allows for the simultaneous exchange of the implant contents with fresh ranibizumab”.
To support surgeons for training in this new procedure, various techniques were considered including lectures, brochures, instructional videos, cadaver wet labs, live animal surgical labs, and mentorships. The use of traditional tissue-based wet lab training is well established, time tested, and considered the gold standard for medical training while learning new surgery skills. However, the researchers have commented that “a new and powerful training approach based on “virtual reality” (VR) technologies has slowly emerged”. According to the study, VR simulators are computer simulated environments that allow users to undertake procedural tasks and experience various associated scenarios in a risk-free environment. Essentially, this modifies a training tool that has long been used by the aeronautic industry. The research report has shown that VR simulators have become highly sophisticated and compelling, “using not only excellent three-dimensional visual recreations of the procedures that rival the best of VR video gaming today, but also haptic feedback that provides the user with procedure-specific realistic resistance”.
Using the implant insertion surgery training simulation, visual feedback is provided using a digital microscope head. For the refill-exchange training simulation, the explanation stated that “visual feedback is provided via a head-mounted display that allows the surgeon to move freely within a narrow area of the virtual world. Both systems are controlled through customized force feedback devices that emulate the look and feel of the instruments used during the real procedures”. The PDS and VR system is supported by Genentech and the working principle of both systems is illustrated online (VRmagic). In the context of the current environment, the report commented that “the growing use of VR in surgical trials and an increasing number of companies embracing it in the training of their investigators, universal adoption of VR as a training option for residents and fellows seems imminent, with retina specialists likely to be spending more of their waking hours in simulated worlds.