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 âborderlineâ or âpoorâ 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.
Public Health Relevance Statement: Project Narrative In low-income countries which lack sufficient trained ophthalmologists, cataract is a leading cause of blindness and many surgeries are conducted by unsupervised non-physician cataract surgeons, resulting in âborderlineâ or âpoorâ surgical outcomes for patients. Here, we propose to integrate telementoring and telestration hardware and software into an ultra-portable ophthalmic surgical microscope so that ophthalmologists can train physicians in ophthalmic surgery techniques over large geographic distances, thereby ultimately increasing the number of trained, certified ophthalmologists in low-income countries. By combining telementoring into a low- cost portable surgical scope, the system could be used in any branch of surgery and in any setting where a dearth of qualified personnel combines with an overwhelming patient population.
Project Terms: Africa; Cataract Extraction; cataract surgery; Certification; Statistical Data Interpretation; Statistical Data Analyses; Statistical Data Analysis; statistical analysis; Elements; Environment; Eye; Eyeball; Eye diseases; eye disorder; ocular disease; ocular disorder; ophthalmopathy; Ocular Prosthesis; Artificial Eye; eye prosthesis; prosthetic vision; vision prosthesis; visual prosthesis; visual prosthetic; Patient Care; Patient Care Delivery; Geography; Grant; Hand; hands; Income; Economic Income; Economical Income; incomes; Iris; Laboratories; Marketing; Mentors; Microscopy; Persons; Ophthalmology; Legal patent; Patents; Physicians; Questionnaires; Reflex action; Reflex; Refugees; Research; Retina; Computer software; Software; Surgical Specialties; Surgical Profession; surgery specialty; Medical Technology; Testing; Price; pricing; Businesses; cataractogenesis; cataractous lenses; Cataract; rural location; rural region; rural area; Microscope; improved; Otomy; incision; Surgical incisions; Site; Phase; Medical; Training; Dental; African; Refugee Camp; Funding; Ophthalmologist; light weight; lightweight; tool; Event; Techniques; System; 3-Dimensional; 3-D; 3D; three dimensional; Country; Blindness; vision loss; visual loss; Robin bird; Robin; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; Surgeon; Performance; Structure; skills; simulation; novel; Study Subject; Modality; Human Resources; Manpower; personnel; Positioning Attribute; Position; Modeling; portability; disparity in health; health disparity; Radio; Qualifying; Randomized; randomisation; randomization; randomly assigned; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Validation; validations; Conventional Surgery; transmission process; Transmission; Development; developmental; cost; digital; under served group; under served individual; under served people; under served population; underserved group; underserved individual; underserved people; Underserved Population; new approaches; novel approaches; novel strategy; novel strategies; Outcome; scale up; blind; innovate; innovative; innovation; usability; prototype; commercialization; stereoscopic; patient population; commercial scale manufacturing; manufacturing ramp-up; scale up batch; scale up production; upscale manufacturing; manufacturing scale-up; wireless network; arm; mass casualty; low income country; surgical outcome; surgery outcome; feasibility trial; Visualization; Resource-limited setting; Low-resource area; Low-resource community; Low-resource environment; Low-resource region; Low-resource setting; Resource-constrained area; Resource-constrained community; Resource-constrained environment; Resource-constrained region; Resource-constrained setting; Resource-limited area; Resource-limited community; Resource-limited environment; Resource-limited region; Resource-poor area; Resource-poor community; Resource-poor environment; Resource-poor region; Resource-poor setting; wireless; Diameter; Dispari
