A New Approach to Vision Therapy Based on Naturalistic 3-D Computer Gaming

Summary Abstract IntroductioniCare will provide e ectivehome based vision therapy through a motivating action based video game that inspires adherence in patients as young asyears oldThe proposed Phase IIB e ort supports development of the commercial systemcloud based tools for providers and patientsestablishment of e cacy and safetyand federal regulatory approvalProblem to be addressedConvergence insu ciency and amblyopia a ect millions of children in the U SThese disorders are associated with symptoms including headachesblurred visioneyestraindi culty concentratingand moreThey can a ect a child s school and social performance and have a detrimental impact on learningIt is known that vision therapyprescribed neuromuscular and neurosensory exercisescan facilitate restoration of visual functionHoweverhome based interventions have historically been ine ective due to low adherence ratesLong Term GoalImproved outcomes and access to care for children diagnosed with convergence insu ciency and amblyopiaPhase II ResultsIn a successful Phase II programa prototype vision therapy game was employed in a study involving children diagnosed with convergence insu ciencynand amblyopianA statisticallysigni cant improvement in vision was found in children who used iCare overweeks of therapyAdherence and technology acceptance results demonstrated improvement over a conventional computer based interventionPhase IIB Program SummaryThe proposed Phase IIB e ort yields a commercial iCare system supporting vision therapy for children as young asyears oldNew development includesgame enhancements to incorporate Phase II lessons learnedcloud services integrationa provider facing web application for monitoring and guiding therapya patient facing web application for software download and parental supportand a HIPAAcompliant data storePursuit of federal regulatory approval for the new device will include documentation of safetycreation of users guide and other labelingand completion of actions supporting premarket noti cationA network ofvision therapy providers around the U Swill participate in multi site trials to demonstrate e cacy for treatment of both convergence insu ciency and amblyopiaCommercial OpportunityThere are approximatelymillion children in the U Sages with vision conditions that are treatable by iCareTremendous enthusiasm for the iCare product is demonstrated by included letters of support included fromdi erent vision therapy providers