Restoringvisiontotheblindhasbeenanage?olddream,butittookanavalancheofbiomedicalresearchand developmentoverthelastfewdecadestobeginturningthisdreamintoreality.Inrecentyearsthepotentialofsaving andrestoringsighthasbeendemonstratedinvitro,inanimalmodels,andinsomecaseseveninhumanpatients.With theadventofearlyclinicaltrialsforthesetherapies,oftenprimarilyaimedatsafetyandenrollingpatientswithprofound visionloss,thereisagrowingneedforvisionassessmentsthatnotonlycanmeasurerudimentaryvision,butreliably demonstratesmallchanges.Ideallythesemeasuresshouldalsodemonstrateefficacyinreal?worldsituations,and includetheuseofvisionfortaskssuchaseye?handcoordination,orientation,andmobility. Inourlaboratorywehavedemonstratedthatthepropertiesofrudimentary?native?visioncanbeassessedwitha visualfunctioningquestionnairespecificallydesignedforultra?lowvision,theULV?VFQ,andwithasetofstandardized visualactivitiesofdailyliving,theULV?ADL.Moreover,wedemonstratedthattheperformanceofusersoftheArgusII retinalprosthesissystemandtheBrainPortvisionsubstitutiondeviceisverysimilartothatofindividualswithnative ULV. ThisapplicationlaysoutaprogramtovalidatethepreviouslycompletedassessmentsinalargerULVpopulation (Aim1),todeveloparangeofadditionalassessments(Aim2),totranslateasubsetofthevisualactivitiesusedinthese assessmentstoreal?worldsituationsandminimizeredundancies(Aim3),andtoassessthesimilarityinperformance betweenindividualswithnativeULVandrecipientsoftheArgusII,BrainPort,andothersight?restoringtreatments(Aim 4).ThenewassessmentsunderAim2willcoverinstrumentalactivitiesofdailyliving(IADL)andorientation&mobility (O&M),andallassessmentswillcoverbothstaticanddynamicscenarios.Ourlong?termcollaboratorDr.Duane Geruschatwillactasaconsultantinthedesignandevaluationoftheseassess.ements. HumansubjectstestingwillbecarriedoutattheJohnsHopkinsWilmerEyeInstituteandtheChicagoLighthouse, whichnotonlycountsasubstantialULVpopulationamongitsemployeesandclients,butalsoanumberofBrainPort users.Investigatorsatbothsiteshaveextensiveresearchexperiencewiththispopulation.O&MscenariosunderAim2 willberealizedinvirtualrealitywiththeassistanceofourpartnersatBaltiVirtual.Theresultingassessmentspromiseto notonlyhaveamajorimpactonfutureclinicaltrialsofsight?restoringtherapies,butalsolaythefoundationto rehabilitationapproachesforrecipientsofsuchtherapies.
Withtheadventofnewtreatmentsthataimtorestorevisiontotheblindthereisanincreasingneedforreliable measurementofverylowvisionlevels,sochangesinvisionrelatedtothetreatmentcanbedocumented.Wehave previouslydesignedsomeofthesemeasuresandareproposingtodemonstratetheirreliabilityinalargepopulationof individualswithprofoundlyimpaired(?ultra?low?)vision,andtodevelopabroadrangeofadditionalvisionmeasures thataresensitivetoultra?lowvision,foruseinfutureclinicaltrialsofsight?restoringtherapies.Participantsinthese studieswillbepatientswithverylimited(so?calledUltra?Low)visionandusersoftheBrainportvisionsubstitutiondevice andtheArgusIIretinalimplant.