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

开发集成到超便携式手术显微镜中的远程指导系统，以治疗服务不足人群的白内障

基本信息

批准号：
10602749
负责人：
Matthew Rudolph Maltese
金额：
$ 29.35万
依托单位：
X-BIOMEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-30 至 2024-09-29
项目状态：
已结题

项目摘要

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.

目前，在像非洲粗糙地区这样的严峻环境中，有数百万人盲目每年由于白内障。如果他们在及时的方式。不幸的是，整个眼科医生和其他外科医生的短缺世界，在许多非洲国家，无监督的非物理学家进行白内障手术，导致患者的“边界”或“差”结果。称为X-Scope，我们的小说，专利，超大型全数字与重型，脆弱和昂贵的传统显微镜相比，手术显微镜提供了一个廉价且轻巧的解决方案。我们的业务模型是破坏$ 2B+手术可视化市场高收入国家拥有我们革命性的，专利的X-scope，以支持全球传播，这都是负担得起的价格。在此应用程序中，我们建议开发整合到利用民用蜂窝无线电网络的X-Scope。我们系统中的电视仪式将使眼科医生能够远程培训医生在非常较大的地理距离上进行眼科手术技术的训练应用于手术的其他分支，有可能使各地的人们受益。此外，我们会的通过多臂证明了远程设备和远程播放的可行性，作为医生的培训方式随机可行性试验。学习对象将被随机地在床边接受心理或在人造眼睛上进行小切口性白内障手术时进行远程伸缩。性能将是客观的使用已建立的眼科评分和统计分析的群体进行比较结果。此外，X-scope的可用性将通过对使用问卷进行管理来确定 Menees和Mens评估X-Scope的易用性和功能。成功完成了这一阶段研究将为第二阶段奠定基础，其中包括X-Scope的X-Scope缩放商业分布和A 510K提交给FDA。最终，此处开发的系统具有广泛使用发达和未发达的世界中的手术，可以扩展到大规模伤亡事件，难民营地和其他外科环境中的环境。