PIVOT Study: Patient-centric Innovative Vision Home Testing
Patients are being sought to participate in a unique study to gauge the feasibility of a home-monitoring system. The PIVOT study is a clinical study to determine if patients with diabetic macular edema (DME) or wet age-related macular degeneration (wet AMD) can use a mobile medical application (mVT™) on a smart phone (Apple iPhone®) or digital tablet (Apple iPad® or Apple iPad Mini®) to monitor their vision at home.
The goal of the study is to determine the feasibility of involving patients in monitoring their visual function at home using this application. The study will also evaluate how comfortable patients are using this application and will assess their ophthalmologist’s thoughts on home vision monitoring using this application.
This pilot also assesses the feasibility of conducting a “decentralized clinical trial. ” A “decentralized clinical trial” means that the clinical trial site is not necessarily at a medical center anymore and more of the trial activities are moved to the patient’s home or within the patient’s local care ecosystem using technology like mobile apps, sensors or telemedicine.
This research study is being sponsored by F. Hoffmann-La Roche Ltd (hereafter referred to as Roche) of Basel, Switzerland. The study is under the direction of Scripps Translational Science Institute (STSI). The Study Coordinator and Principal Investigator are both members of the staff at STSI.