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

目前，在像非洲农村地区这样的严峻环境中，有数百万人失明 每年都会因为白内障。如果他们接受正确的治疗，这是一种很容易预防的情况 及时地。不幸的是，眼科医生和其他外科医生在全球范围内日益短缺。 在世界上，在许多非洲国家，无人监督的非医生进行白内障手术，导致 对于患者来说，“边缘”或“糟糕”的结果。名为X-Scope，我们的新颖、专利、超便携全数字 与笨重、脆弱和昂贵的传统显微镜相比，外科显微镜提供了一种 价格低廉、重量轻的解决方案。我们的业务模式是颠覆20亿美元以上的手术可视化市场 高收入国家使用我们革命性的专利X-Scope来支持全球传播，所有这些都是在 实惠的价格。 在此应用程序中，我们建议开发集成到 X-Scope利用民用蜂窝无线电网络。我们系统中的远程指导将允许眼科医生 远程培训医生在非常远的地理距离内进行眼科手术技术培训，以及何时 应用于外科的其他分支，有可能造福于世界各地的人们。此外，我们还将 通过多臂演示远程传送和远程传送作为医生培训方式的可行性 随机可行性试验。研究对象将被随机分配到床边接受指导或 他们在为假眼进行小切口白内障手术时进行远程监护。表演将会客观地 使用已建立的眼科评分标准的组之间的比较和统计分析 结果。此外，X-Scope的可用性将通过管理使用调查问卷来确定 学员和导师评估X-Scope的易用性和功能。圆满完成这一阶段 研究将为第二阶段奠定基础，该阶段包括扩大商业分发的X-Scope和 510K提交给FDA。最终，本文开发的系统具有在所有分支机构广泛使用的潜力 外科手术在发达国家和不发达世界，并可扩展到大规模伤亡事件，难民 营地和其他严酷环境下的外科手术环境。

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.