Vivid Vision Incorporated

CLUSTERED HOME ASSESSMENT OF VISUAL FIELDS IN PATIENTS WITH GLAUCOMA - PROJECT SUMMARY/ABSTRACT GLAUCOMA IS THE SECOND LEADING CAUSE OF IRREVERSIBLE VISION LOSS IN AMERICANS. EFFECTIVE TREATMENT REQUIRES THE PATIENT TO TAKE VISUAL FIELD TESTS OVER TIME, TO MONITOR FOR PROGRESSION OF VISUAL FIELD LOSS. IN MANY PATIENTS THERE IS NO PROGRESSION, BUT WHEN IT OCCURS IT MUST BE DETECTED AS QUICKLY AS POSSIBLE IN ORDER TO SAVE VISION BY USING A MORE AGGRESSIVE TREATMENT. PATIENTS WHOSE VISION IS ACTUALLY STABLE DON’T KNOW IT, SO THEY WORRY UNNECESSARILY. CONVENTIONAL TESTS TO MEASURE VISUAL FIELDS ARE TOO DIFFICULT TO TAKE. THEY ARE FATIGUING AND THE EQUIPMENT THEY USE IS EXPENSIVE AND BULKY A SKILLED PERIMETRIST IS STILL REQUIRED TO TRAIN THE PATIENT HOW TO TAKE THE TEST AND TO MONITOR FOR EYE MOVEMENTS AND PATIENT FATIGUE. AS A RESULT, GLAUCOMA PATIENTS TYPICALLY HAVE A VISUAL FIELD TEST ONLY ONE TO THREE TIMES A YEAR. AND UNFORTUNATELY, THE RESULTS OF THESE TESTS HAVE HIGH VARIABILITY DUE TO THE NECESSARILY SHORT DURATION OF THE TEST. THUS, THERE IS LARGE ERROR WHEN ESTIMATING THE RATE OF DISEASE PROGRESSION FROM VISUAL FIELDS IN A PATIENT WITH GLAUCOMA, AND AN URGENT NEED TO DO ADDITIONAL TESTING AT HOME TO OVERCOME THE DATA LIMITATION. WE DEVELOPED A TEST, CALLED VIVID VISION PERIMETRY (VVP-10), THAT SUBSTANTIALLY INCREASES THE QUANTITY OF VISUAL FIELD DATA A PATIENT CAN COLLECT. PATIENTS TAKE VVP-10 AT HOME ON A LOW-COST VIRTUAL REALITY (VR) HEADSET. WE HAVE MADE THE TEST MUCH MORE USER-FRIENDLY, USING A NOVEL TASK. VVP-10 ALLOWS THE PATIENT TO FREELY MOVE THEIR EYES AND TO KNOW EXACTLY WHEN STIMULI WILL APPEAR. IT GIVES FEEDBACK TO THE PATIENT AFTER EVERY STIMULUS , AND MAKES THE TEST MORE LIKE A VIDEO GAME. PATIENTS HAVE THE OPTION OF GUESSING OR NOT, BECAUSE GUESSING DOES NOT AFFECT THE TEST OUTCOME. DURING PHASE I OF THIS PROJECT, WE DEMONSTRATED FEASIBILITY BY SHOWING THAT ELDERLY GLAUCOMA PATIENTS CAN PERFORM THE TEST AT HOME WITHOUT IN-PERSON TRAINING. THE RESULTS AGREED WELL WITH CONVENTIONAL TESTS, AND OUR MATHEMATICAL MODELS SUGGEST THAT TAKING A CLUSTER OF 10 TESTS FOUR TIMES A YEAR COULD REDUCE BY MORE THAN HALF THE NUMBER OF MONTHS NEEDED TO DETECT RAPID PROGRESSION. IN THIS DIRECT TO PHASE II PROJECT, WE WILL MAKE THE TEST STILL EASIER TO PERFORM, OPTIMIZE THE QUALITY OF THE DATA COLLECTED, AND VERIFY THAT VVP-10 CAN REDUCE BY HALF THE NUMBER OF MONTHS NEEDED TO DETECT RAPID PROGRESSION. THE NEW TEST IS BEING DEVELOPED BY VIVID VISION, INC., A SEVEN-YEAR-OLD COMPANY BASED IN SAN FRANCISCO, CA. THE COMPANY SELLS A BINOCULAR VISION TREATMENT PRODUCT USED BY 350 CLINICS WORLDWIDE. IT HAS EXPERTISE IN PSYCHOPHYSICS, SOFTWARE ENGINEERING FOR VR GAMES, HIPAA-COMPLIANT TELEMEDICINE, IP PROTECTION, MARKETING, AND SALES. LEADING GLAUCOMA SPECIALISTS AT THE UCSF SCHOOL OF MEDICINE AND THE NYU SCHOOL OF MEDICINE HAVE JOINED THE TEAM TO CARRY OUT A ONE-YEAR, MULTI-SITE STUDY OF VVP-10 IN 65 PATIENTS WITH GLAUCOMA.

USE OF A VIRTUAL REALITY HEADSET TO TEST THE UNTESTABLE PATIENTS WITH GLAUCOMA - ABSTRACT – THREE MILLION AMERICANS AND 76 MILLION PEOPLE GLOBALLY SUFFER FROM GLAUCOMA, THE 2ND LEADING CAUSE OF IRREVERSIBLE VISUAL FIELD (VF) LOSS AND BLINDNESS. VF TESTING REMAINS ESSENTIAL FOR MONITORING GLAUCOMA PROGRESSION AND GUIDING TREATMENT DECISIONS, YET CURRENT STANDARD AUTOMATED PERIMETRY (SAP) TESTS PRESENT BARRIERS TO RELIABLE DATA COLLECTION. AS MUCH AS 41% OF VF TESTS ARE PERFORMED UNRELIABLY, WITH FIXATION LOSS (FL) BEING THE MOST COMMON ISSUE. UNRELIABLE VF TESTS CAUSE DELAYED DIAGNOSIS, INACCURATE PROGRESSION MONITORING, MISGUIDED AND DELAYED TREATMENT DECISIONS, AND SCREEN FAILURES DURING CLINICAL TRIAL RECRUITMENT. MANY PATIENTS FIND SAP FATIGUING, OR HAVE DIFFICULTY FOLLOWING THE INSTRUCTIONS, SO IT IS NOT SURPRISING THAT ADVANCED AGE, COGNITIVE IMPAIRMENT, AND LANGUAGE BARRIERS ARE ASSOCIATED WITH LOWER TEST RELIABILITY IN THE US. VIVID VISION INC. AIMS TO “TEST THE UNTESTABLE” USING NEW TECHNOLOGY BY WHICH OTHERWISE CONSISTENTLY UNRELIABLE TEST-TAKERS CAN BE TESTED RELIABLY. VIVID VISION HAS DEVELOPED VIVID VISION PERIMETRY (VVP), A NOVEL VR HEADSET-BASED VF TEST DESIGNED TO REDUCE TEST FATIGUE AND INCREASE ENGAGEMENT WHILE ELIMINATING BOTH EYE FIXATION AND HEAD STATIONARITY REQUIREMENTS, FEATURING A USER-FRIENDLY INTERACTIVE TUTORIAL IN THE TEST-TAKER’S PREFERRED LANGUAGE TO MINIMIZE DEPENDENCE ON IN-PERSON TRAINING. VVP REPRESENTS A PARADIGM SHIFT IN PERIMETRY TESTING BY FUNDAMENTALLY CHANGING HOW FIXATION IS HANDLED DURING TESTING. INSTEAD OF REQUIRING SUSTAINED FIXATION AT A CENTRAL POINT (WHICH CAN BE DIFFICULT OR IMPOSSIBLE FOR SOME PATIENTS), VVP EMPLOYS AN ACTIVE FIXATION TASK THAT NATURALLY ENGAGES FOVEAL VISION ACROSS DIFFERENT VISUAL DIRECTIONS. THIS INNOVATION, COMBINED WITH OUR PATIENT- CENTERED AND GAMIFIED DESIGN, CREATES A MORE ENGAGING AND LESS FATIGUING EXPERIENCE WHILE AIMING TO IMPROVE OVERALL TEST RELIABILITY VIA IMPROVING FIXATION. THE TAKE-HOME CAPABILITY OF THE HEADSET-BASED TESTS ALLOWS VVP TO BE COMPLETED AT HOME WITH HIGHER REPETITIONS, DRAMATICALLY REDUCING THE CALENDAR TIME NEEDED FOR PATIENTS TO ACHIEVE RELIABLE RESULTS - A PROCESS THAT TYPICALLY TAKES YEARS WITH SAP. BUILDING ON DATA EQUIVALENT TO PHASE I, VVP HAS DEMONSTRATED SUCCESS IN TESTING PATIENTS WITH UNRELIABLE SAP RESULTS, WITH PREVIOUS STUDIES SHOWING STRONG CORRELATION WITH SAP WHILE ACHIEVING LOWER VARIABILITY. VVP WAS PREVIOUSLY APPROVED TO ENTER THE MARKET UNDER AN EMERGENCY AUTHORIZATION RECEIVED DURING THE COVID PANDEMIC, WHICH HAS EXPIRED. THROUGH THIS DIRECT-TO-PHASE-II SBIR PROJECT, VIVID VISION AIMS TO ESTABLISH VVP AS A SCREENING AND MONITORING TOOL THAT PRODUCES MORE CONSISTENTLY RELIABLE VF TESTS COMPARED WITH SAP, ADDRESSING TWO CRITICAL CHALLENGES IN VISUAL FIELD TESTING: PATIENTS WHO HAVE CHRONICALLY UNRELIABLE SAP RESULTS AND THE MULTI-SESSION LEARNING CURVE FOR NEW PATIENTS. VIVID VISION WILL UNDERTAKE THREE SPECIFIC AIMS: 1) DEMONSTRATING VVP’S IMPROVED RELIABILITY IN GLAUCOMA PATIENTS WITH REPEATEDLY HIGH FL, 2) COMPARING UNRELIABILITY FOR NEWER VISUAL FIELD TEST TAKERS USING VVP AND SAP RESPECTIVELY, AND 3) CREATE AN ANALYTICS AND DATA DISPLAY DASHBOARD. IF SUCCESSFUL, THIS WORK WILL SUPPORT VVP’S FDA APPLICATION AS A CLASS II MEDICAL DEVICE.