REBISCAN, Inc. — Department of Health and Human Services SBIR Phase II: NEI

Description

Project Summary Abstract !Amblyopia is vision loss caused by suppression of a structurally normal eye due to strabismusasymmetric refractionanisometropiaor deprivationTreatment becomes challenging if not caught by agebut half of all patients in the US are undetected and untreated until after it is too latemaking it the leading cause of preventable vision lossRebion has developed retinal birefringence scanningRBSinto a commercial productthe RBS based Pediatric Vision ScannerPVSwhich detects amblyopia and strabismus withaccuracycompared withaccuracy of non RBS methodsHowever RBS based scanning faces challengesincluding the need for costly moving parts and the presence of significant background noise necessitating background measurementsthat may limit widespread commercial acceptance of this technologyWith prior Phase I NEI fundingEYRebion has successfully built a new approach toward assessment of retinal birefringence that we call retinal birefringence imagingRBILike RBSthis approach measures the polarization signature produced by the Henle nerve fibers at the center of fixation of the retinathus objectively detecting ocular fixationbut it can be implemented with no moving parts and without the need for background measurementsImaging are obtained in a fraction of a secondvsseconds of scanning required for an accurate RBS measurementThe design also allows for future incorporation of a photoscreening channel for assessment of refractive error in synchrony with detection of amblyopia and strabismusIn this Phase II studywe will test the hypothesis that the performance of the RBI device can match the sensitivityspecificityand accuracy of the commercially available PVS device in a large scale clinical trialThe RBI device built with Phase I funding will be deployed with the Retina Foundation of the Southwestand tested in both the enriched population of eye care clinicsas well as un enriched populations of primary care clinicsThe disease prevalence of primary care clinics will more closely mimic the disease prevalence of the general populationwhile the disease prevalence of eye clinics will allow the study to carry statistical significance in the most cost effective use of NIH fundsSuccessful execution of project milestones will lead to an immediate transition to regulatory clearance with FDA and manufacturing with Rebionandapos s contract manufacturerThis advance will greatly reduce expenses and complexities related to pediatric vision screening Project Narrative Rebion has developed a handheldno moving parts device for providing quicknoninvasive detection of amblyopia and strabismusthe leading causes of preventable vision loss in children in the United StatesCurrent methodsincluding Rebionandapos s own Pediatric Vision ScannerPVSrequire complex scanning equipment that is prone to confounding error produced by ambient light or short attention spansClinical trials in this proposal will test the accuracy of this image based method and compare it to comprehensive ophthalmic examinations and Rebionandapos s own PVS