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，在非洲农村地区这样严峻的环境中，有数百万人失明 每年都有白内障。这是一个很容易预防的条件，如果他们接受正确的治疗， 适时不幸的是，整个世界的眼科医生和其他外科医生越来越短缺， 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， 患者的“临界”或“差”结果。称为X-范围，我们的新颖，专利，超便携式全数字 与笨重、易碎且昂贵的传统显微镜相比，手术显微镜提供了一种 廉价且轻便的解决方案。我们的商业模式是颠覆20亿美元以上的手术可视化市场， 我们革命性的专利X-Scope支持全球传播， 价格实惠。 在此应用中，我们建议开发远程监控和远程监控功能集成到 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大的地理距离上的眼科手术技术， 应用于其他外科分支，有可能造福世界各地的人们。此外，我们将 证明远程监护和远程指导作为医生通过多臂培训模式的可行性 随机可行性试验。研究受试者将随机接受床边指导或 在他们进行小切口人工眼白内障手术时进行远程监护。业绩将客观 使用已建立的眼科评分标准进行组间比较， 结果此外，将通过管理使用调查问卷来确定X范围的可用性， 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，第二阶段包括扩大X-Scope的商业分销规模， 向FDA提交510 k。最后，本文开发的系统具有广泛应用于医疗器械的所有分支的潜力。 手术在发达国家和不发达国家，并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。