Project Grant R44EY034066

DEVELOPMENT OF A TELE-MENTORING SYSTEM INTEGRATED INTO AN ULTRA-PORTABLE SURGICAL MICROSCOPE TO TREAT CATARACT IN UNDERSERVED POPULATIONS - PROJECT SUMMARY CURRENTLY, THERE ARE MILLIONS OF PEOPLE WHO SUFFER FROM DEGRADING EYESIGHT DUE TO PREVENTABLE DISEASES THAT REQUIRE EYE SURGERY. THESE DISPARITIES IN SURGICAL EYE CARE EXIST IN BOTH HIGH-INCOME COUNTRIES SUCH AS THE UNITED STATES, AND LOW-INCOME COUNTRIES FOUND IN PLACES LIKE AFRICA. FURTHER, THE DISPARITY IN CARE IS LIKELY TO BE EXACERBATED IN THE COMING YEARS, AS THE SUPPLY OF TRAINED OPHTHALMOLOGISTS DECREASED BY 20% BETWEEN 2010 AND 2025; THE TREND IN DECREASED PER CAPITA EYE SURGEONS IS PROJECTED TO CONTINUE THROUGH 2035. STREAMLINING AND INCREASING THE AVAILABILITY OF TRAINING FOR OPHTHALMOLOGISTS IS KEY. CALLED THE GOSCOPE, OUR NOVEL, PATENTED, ULTRA-PORTABLE, ALL-DIGITAL SURGICAL MICROSCOPE, OFFERS AN INEXPENSIVE AND LIGHTWEIGHT SOLUTION COMPARED TO THE HEAVY, FRAGILE, AND EXPENSIVE TRADITIONAL MICROSCOPES. THIS APPLICATION IS A CONTINUATION OF OUR SUCCESSFUL PHASE 1 SBIR RESEARCH. IN PHASE ONE WE INTEGRATED TRAINING CAPABILITIES INTO GOSCOPE BY ADDING TELEMENTORING AND TELESTRATION CAPABILITIES. 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. IN PHASE I, WE DEMONSTRATED THE FEASIBILITY OF TELEMENTORING AND TELESTRATION AS A TRAINING MODALITY FOR PHYSICIANS VIA A MULTI-ARM RANDOMIZED FEASIBILITY TRIAL. STUDY SUBJECTS WERE RANDOMIZED TO RECEIVE EITHER MENTORING AT THE BEDSIDE OR TELEMENTORING AS THEY PERFORMED SMALL INCISION CATARACT SURGERY ON ARTIFICIAL EYES. RESULTS SHOW THAT THE NOVEL MICROSCOPE PERFORMED SIMILARLY TO AN OPERATING MICROSCOPE IN TERMS OF THE TIME REQUIRED TO COMPLETE THE SURGERY AND THE QUALITY OF THE SURGERY. IN THIS PHASE TWO APPLICATION WE SCALE UP AND UPGRADE OUR MICROSCOPE CAPABILITY AND COMPLETE COMMERCIALIZATION MANUFACTURING AND REGULATORY REQUIREMENTS. THEN WE TRAIN A COHORT OF SURGEONS ON HOW TO USE GOSCOPE WITH TELESTRATION AND TELEMENTORING, THUS VALIDATING THIS NEW MEDICAL DEVICE FOR CLINICAL USE. 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. OUR BUSINESS MODEL IS TO DISRUPT THE $2B+ SURGICAL VISUALIZATION MARKET IN THE UNITED STATES AND OTHER HIGH-INCOME COUNTRIES WITH OUR REVOLUTIONARY, PATENTED GOSCOPE TO SUPPORT DISSEMINATION GLOBALLY, ALL AT AN AFFORDABLE PRICE.