EYEnexo LLC — Department of Health and Human Services SBIR Phase II: NEI

Description

PROJECT SUMMARY ABSTRACT In this project we propose to complete development and performance evaluation of a smartphone based mobile medical applicationEyeTurnfor use by eye care professionals and lay people to screen for strabismuseye misalignmentStrabismus develops in an estimatedof the U Spopulation and is a leading risk factor for amblyopia in young childrenEarly detection and treatment are critical to prevention of permanent vision lossesyet onlyof U Schildren under agereportedly receive vision screeningIn the elderly and in head trauma populations where the prevalence is highestuntreated strabismus can result in postural instabilityleading to a significantly greater risk of devastating fallsHoweversignificant barriers of cost and availability of trained examiners limit access to strabismus screening for at risk populationsespecially in under served rural and low income areas and elder care facilitiesThe novel EyeTurn app provides the first image based tool for eye alignment testing by lay persons without reliance on a costly deviceWe propose to further develop the EyeTurn app to improve reliability of automatic eye detection and vertical strabismus measurementadd HIPAA compliant patient data managementimprove the operator interface for coveruncover testing and for screening home useand incorporate modules for user trainingpatient educationand doctor findingWe will evaluate EyeTurn performance relative to standard test methodology in targeted populations likely to contain subjects who are difficult to accurately measureincluding both young children and head trauma or low vision patientsWe will also report initial estimates of EyeTurn sensitivity and specificity in a pilot scale application to pediatric screeningAt the conclusion of the Phase II projectwe will have demonstrated accuracyreliability and effective range comparable to or exceeding costly tests now employed in strabismus screeningBringing this low cost product to wide commercial availabilitywe could make possible a paradigm shift in cost benefit calculations for strabismus screening and measurement globallyresulting in greater access to treatment for strabismus affected individualsA demonstrated effectiveness for use by vision care professionals will position EyeTurn to apply for FDA pre market approval and perform clinical trials in support of use by lay people for strabismus screening