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

• 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
• 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
• 来源: https://reporter.nih.gov/project-details/10602749
• 关键词: 3-Dimensional; Africa; African; Blindness; Businesses; Cataract; Cataract Extraction; Certification; Computer software; Conventional Surgery; Country; Dental; Development; Diameter; Disparity; Elements; Environment; Event; Eye; Eye diseases; Funding; Geography; Grant; Hand; Human Resources; Income; Iris; Laboratories; Legal patent; Marketing; Medical; Medical Technology; Mentors; Microscope; Microscopy; Modality; Modeling; Ocular Prosthesis; Operative Surgical Procedures; Ophthalmologist; Ophthalmology; Outcome; Patient Care; Patient-Focused Outcomes; Performance; Persons; Phase; Physicians; Positioning Attribute; Price; Qualifying; Questionnaires; Radio; Randomized; Reflex action; Refugee Camp; Refugees; Research; Resource-limited setting; Retina; Robin bird; Site; Small Business Innovation Research Grant; Statistical Data Interpretation; Structure; Study Subject; Surgeon; Surgical Specialties; Surgical incisions; System; Techniques; Testing; Training; Underserved Population; Validation; Visualization; arm; blind; commercialization; cost; digital; feasibility trial; health disparity; improved; innovation; light weight; low income country; manufacturing scale-up; mass casualty; novel; novel strategies; patient population; portability; prototype; rural area; scale up; simulation; skills; stereoscopic; surgery outcome; tool; transmission process; usability; wireless; wireless network

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，在非洲农村地区等严峻的环境中，有数百万人失明 每年由于白内障，如果他们接受正确的治疗，这是一种很容易预防的疾病。 不幸的是，眼科医生和其他外科医生越来越短缺。 在世界各地，在许多非洲国家，非医生在无人监督的情况下进行白内障手术，导致 我们的新型、专利、超便携式全数字设备称为 X-Scope。 与笨重、易碎且昂贵的传统显微镜相比，手术显微镜提供了 我们的商业模式是廉价且轻量级的解决方案，旨在颠覆 20 亿美元以上的手术可视化市场。 高收入国家利用我们革命性的专利 X-Scope 支持全球传播 实惠的价格。 在此应用中，我们建议开发集成到系统中的远程指导和远程监控功能 X-Scope 在我们的系统中利用民用蜂窝无线电网络，使眼科医生能够 在很远的地理距离上远程培训医生眼科手术技术，以及何时 应用于其他外科领域，有可能造福世界各地的人们。 通过多臂展示远程指导和远程监测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接受床边指导或指导。 他们在人造眼上进行小切口白内障手术时进行远程指导，表现将是客观的。 使用既定的眼科评分标准和统计分析对各组进行比较 此外，X-scope 的可用性将通过使用调查问卷的管理来确定。 学员和导师评估 X-Scope 的易用性和功能 成功完成第一阶段。 研究将为第二阶段奠定基础，其中包括扩大 X-Scope 的商业发行规模和 最终，本文开发的系统已向 FDA 提交 510k 申请，具有在所有分支机构广泛使用的潜力。 发达国家和不发达国家的手术，并且可以扩展到大规模伤亡事件、难民 营地和其他严峻环境中的手术环境。