Development of a tele-mentoring system integrated into an ultra-portable surgical microscope to treat cataract in underserved populations

X-Biomedical, Inc., Newtown Square PA

Investigators

Abstract

Currently, in austere environments like the rural regions of Africa, there are millions of people who go blind each year due to cataract. This is an easily preventable condition if they receive the correct treatment in a timely manner. Unfortunately, there is a growing shortage of ophthalmologists and other surgeons throughout the world, and in many African countries unsupervised non-physicians perform cataract surgery, resulting in “borderline” or “poor” outcomes for patients. Called the X-Scope, our novel, patented, ultra-portable all-digital surgical microscope, compared to the heavy, fragile, and expensive traditional microscopes, offers an inexpensive and lightweight solution. Our business model is to disrupt the $2B+ surgical visualization market in high-income countries with our revolutionary, patented X-Scope to support dissemination globally, all at an affordable price. In this application we propose to develop telementoring and telestration capabilities integrated into the X-Scope utilizing civilian cellular radio networks. Tele-mentoring in our system would allow ophthalmologists to remotely train physicians in ophthalmic surgery techniques over very large geographic distances, and when applied to other branches of surgery, has the potential to benefit people everywhere. Furthermore, we will demonstrate feasibility of telementoring and telestration as a training modality for physicians via a multi-arm randomized feasibility trial. Study subjects will be randomized to receive either mentoring at the bedside or telementoring as they perform small incision cataract surgery on artificial eyes. Performance will be objectively compared between the groups using an established ophthalmology scoring rubric and statistical analyses of results. Additionally, usability of X-scope will be determined by administration of a USE questionnaire to mentees and mentor to assess ease of use and functionality of X-Scope. Successful completion of this Phase I research will lay groundwork for Phase II, which includes scale up of X-Scope for commercial distribution and a 510k submission to FDA. Ultimately, the system developed herein has potential for broad use in all branches of surgery in the developed and un-developed world, and can be extended to mass casualty events, refugee encampments, and other surgical environments in austere settings.