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.

Public Health Relevance

Withtheadventofnewtreatmentsthataimtorestorevisiontotheblindthereisanincreasingneedforreliable measurementofverylowvisionlevels,sochangesinvisionrelatedtothetreatmentcanbedocumented.Wehave previouslydesignedsomeofthesemeasuresandareproposingtodemonstratetheirreliabilityinalargepopulationof individualswithprofoundlyimpaired(?ultra?low?)vision,andtodevelopabroadrangeofadditionalvisionmeasures thataresensitivetoultra?lowvision,foruseinfutureclinicaltrialsofsight?restoringtherapies.Participantsinthese studieswillbepatientswithverylimited(so?calledUltra?Low)visionandusersoftheBrainportvisionsubstitutiondevice andtheArgusIIretinalimplant.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Research Project (R01)
Project #
5R01EY028452-02
Application #
9559710
Study Section
Bioengineering of Neuroscience, Vision and Low Vision Technologies Study Section (BNVT)
Program Officer
Wiggs, Cheri
Project Start
2017-09-30
Project End
2021-05-31
Budget Start
2018-06-01
Budget End
2019-05-31
Support Year
2
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Johns Hopkins University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21205