IGATESHandbook

InternationalGlobeandAdnexalTraumaEpidemiologyStudy(IGATES)

StudyHandbookVersion1.0:5thAugust2017

AuthorsforIGATES-1handbook:DrRupeshAgrawal.Email:Rupesh_agrawal@ttsh.com.sgAnnetteHoskinEmail:annettehoskin@yahoo.com.auDr.DineshVisvaGunasekeran.Email:dineshvg@hotmail.sg,

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Contents 1.0ProjectOverview..............................................................................................................................3

1.1WhyIGATES?................................................................................................................................3

1.2IGATES-1andIGATES-2................................................................................................................4

1.3KeyCollaboratingOrganisations..................................................................................................4

2.0ParticipatingCentres........................................................................................................................4

2.1Acknowledgementofthestudyprotocolandauthorship...........................................................4

3.0SteeringCommittee.........................................................................................................................5

3.1StudyMentors:.............................................................................................................................5

3.2PrincipleInvestigators:.................................................................................................................5

3.3Websiteprotocolandadministrator:...........................................................................................5

3.4CountryRepresentatives..............................................................................................................5

4.0InstitutionalReviewBoardApprovals..............................................................................................6

4.1InstitutionalReviewandEthicsApproval.....................................................................................6

4.2ConfidentialityofParticipantData...............................................................................................6

5.0AuthorshipPolicy:............................................................................................................................7

5.1PrimaryManuscripts....................................................................................................................7

5.2SecondaryManuscripts................................................................................................................7

5.3MeetingPresentationPolicy:.......................................................................................................8

6.0DataEntry.........................................................................................................................................8

6.1IGATES1.......................................................................................................................................8

6.1.1IGATES-1Exclusionandinclusioncriteria..............................................................................9

6.2IGATES2.......................................................................................................................................9

6.2.1IGATES-2ExclusionandinclusioncriteriaandclassificationofMajororMinorTrauma......9

6.3TheIGATESDataSystem............................................................................................................10

6.4DataEntry...................................................................................................................................11

6.4.2EnteringDatafromMedicalRecords......................................................................................11

Signedauthoritytoparticipateinthestudyandabidebytheagreedconditions.

Sitenumber:…………………………………………………………………………………………

Siteco-ordinator:………………………………………………………………………………………….

Countryco-ordinator:………………………………………………………………………………………

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1.0ProjectOverview

1.1 Why IGATES? Traumaticeyeandfacialinjuriesencompassasignificantproportionofallpatients

presentingtoemergencydepartments1.Oculartraumaisassociatedwithconsiderablemorbidityandhealthcare-associatedcosts2,3.Theabilitytopredictandanticipateoutcomesinpatientswithoculartraumaiscriticaltodevelopingeyeinjurypreventionstrategiesandappropriatetreatmentplans,aswellastoadviseandcounselpatients.

TheBirminghamEyeTraumaTerminologySystem(BETTS)andOcularTraumaScore(OTS)havebeenwidelyadoptedinternationallysincetheywerepublishedandremainthebenchmarkforclassificationofoculartrauma.WhilstthecurrentOTShassignificantlycontributedinreducingtheambiguityaboutclassificationandassistedthepredictionofoutcomesformostopenglobetrauma,thereremainsomelimitationsandcontroversies.

Thisincludestheexclusionofadnexalinjuriesfromthescore.FurtherexamplesincludewhetherthesignificanceaccordedtopresentingVAisjustifiable,andwhetherRAPDisanabsolutebiomarkerforthepatient’sfinalvisualoutcome.Firstdevelopedinearlynineties,itisnotknownifBETTSandOTSaccuratelyreflectcurrentstateofarttraumapracticeandoutcome.Inclinicalpractice,theBETTSandOTSclassificationscanbedifficultasnotalldataiscollected.WeaimtobuildonthevaluableaspectsoftheexistingBETTSandOTStobuildamorerobustmodelincorporatingawiderrangeofrelevantmarkersrelatingtotheoutcome.

TheprimaryaimoftheInternationalGlobeandAdnexalTraumaEpidemiologyStudy(IGATES)istousecloudcomputingandbigdataanalyticstodevelopaprognosticclassificationsystemforoculartraumathroughinternationalcollaboration.Thisscorewillservetodevelopstrategiestopreventoculartraumaandmitigateitsconsequences.

Specificallywewillaimto;

i) Identifythefactorsaffectingtheoutcomeofopenglobeandadnexalinjury(oculartrauma)

ii) Developaprognosticclassificationsystemforoculartraumaiii) Conductalargemulticentreretrospectivereviewofophthalmictraumautilising

therevised“OphthalmicTraumaScore”(OTS2)

1YadavK,CowanE,WallS,GennisP.Orbitalfractureclinicaldecisionruledevelopment:burdenofdiseaseanduseofamandatoryelectronicsurveyinstrument.AcadEmergMed18:313-316,2011.2KoMJ,MorrisCK,KimJW,etal.Orbitalfractures:nationalinpatienttrendsandcomplications.OphthalPlastReconstrSurg29:298-303,2013.3BeshayN,KeayL,WatsonSL,etal.TheepidemiologyofOpenGlobeInjuriespresentingtoatertiaryreferraleyehospitalinAustralia.Injury;2017.48(7);1348-54.

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1.2 IGATES-1 and IGATES-2 TheIGATESstudywillhavetwodistinctphasesinthestudyofpatientswithglobe

andadnexaltrauma.IGATES-1aretrospectivecohortstudyandIGATES-2aprospectivestudy.IGATES-1willcommenceinJuly2017withdatacollectionundertakenovera6monthperiodofpatientspresentingwithoculartraumabetween2006-2015atparticipatingcenters.Dataanalysiswillbeconductedinthefollowing6months,withfindingsusedtodesignthekeyelementsforstudyandaclinicalriskscoreforvalidationintheprospectivestudyIGATES-2.IGATES-2isanticipatedtocommenceinJune2018withdatacollectioncontinuingfora5yearperiodfromcommencement.

TheprimaryoutcomesmeasuresforBETTSwerethefinalvisualoutcomeandanatomicaloutcome.Wealsostudytheincidenceofocularcomplicationsrelatedtooculartrauma,thesignificanceofeyelidand/oradnexaltrauma,andextra-ocularcomplicationssuchasintracranialinjury.Potentialriskfactorsforoutcomeswillalsobeassessed.

Thisstudywillprovideextensivedatarelatingtothefactorsaffectingtheoutcomeofopenglobeinjuryandrepair.Thestudyisalsoanticipatedtoprovidethelargestdatasetofoutcomesfromglobeandadnexaltraumatodate.

1.3 Key Collaborating Organisations TheIGATESstudyissupportedbytheAsiaPacificOcularTraumaSociety(APOTS),InternationalSocietyofOcularTrauma(ISOT),CollaborativeOcularTuberculosisStudygroup(COTS),OcularTraumaSocietyofIndia(OTSI),andAmericanSocietyofOcularTrauma(ASOT).

2.0 Participating Centres

SeeAnnexureA.

2.1 Acknowledgement of the study protocol and authorship

Allparticipatingcentreswillreadandreviewthehandbookacknowledgingthetermsofparticipationincludingdataaccessandstorageandauthorship.

AnyquestionsrelatingtothetermsshallbeaddressedtoProfessorAgrawal.

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3.0 Steering Committee

3.1 Study Mentors:

ProfessorFerencKuhn,USA

ProfessorHuaYan,China

ProfessorSNatarajan,India

ProfessorMichaelGrant,USA

3.2 Principal Investigators (PI):

A/ProfRupeshAgrawal,Singapore

MsAnnetteHoskin,Australia

A/ProfGangadharaSundar,Singapore

A/ProfFasikaWoretta,UnitedStates

DrAndrésRousselot,Argentina

ProfessorStephanieWatson,Australia

3.3 Web platform and Big-data protocol administrator:

Dr.DineshVisvaGunasekeran,Singapore

3.4 Country Representatives

SouthernIndia-DrKim,DrParveen,DrChaitraJayadev,DrRKim

NorthernIndia-DrShakeenSingh

CentralIndia-ProfessorRekhaKhandelwal

EastIndia–DrKasturiBhatacharjee

WestIndia–DrMehulShah,DrSNatarajan

Singapore-DrVictorKoh,ProfGanga

Australia-DrStephanieWatson,MsAnnetteHoskin

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China–ProfHuaYan

USA–ProfFasikaWoretta

Malaysia–DrAin

HongKong–DrKendrick

Canada–DrKashifBaig

UK-DrFelippe

Nepal–DrEliPradhan

4.0 Institutional Review Board Approvals TheIGATESprotocolrequiresallparticipatingsitestoobtainapprovalfromtheirlocalInstitutereviewboards(IRB)priortodatacollection.WheretheIRBdictatesthatethicalclearanceisnotrequiredforretrospectivedataentry,aletterhastobeobtainedfromthelocalIRBandprovidedtotheIGATESteamforrecordkeepingbeforestartingdataentry.

4.1 Institutional Review and Ethics Approval ItisrequiredthattheethicsapprovalincludethesametitleforallcentresandcontaintheIGATESweb-baseddataaggregationplatformlink.EachsiteshallprovideafinalcopyoftheethicsapprovaltoA/Prof.RupeshAgrawalbeforestartingdataentry.

4.2 Confidentiality of Participant Data Thedataforallthepatientsenteredontheweb-baseddataaggregationplatformshallbemaintainedinaccordancewithlegalregulationsandallagreementsmadewiththerelevantIRBbythesitePI.Nopatientidentifiersshouldbeenteredintheonlinewebdatabase.Eachrecruitedpatientwillhaveacodedparticipantregistrationnumber.Ahardcopysite-basedregistryofrecruitedpatientsandcorrespondingparticipantregistrationnumbersistobemaintainedbythesitePI,wherebyonlythesitePIhasaccesstothislistofpatientidentifiers.

ThecodingforrecruitedpatientsisAAA-BBBBBwhereby“AAA”isthesiteIDassignedtothesitefortheIGATESstudy,and“BBBBB”isthelast5charactersofthepatient’spassport/nationalidentificationnumber.ThisensuresthattheSitePIisabletotracebackanyrecruitedpatientbasedontheirparticipantregistrationnumberintheeventthatanyclarificationsaresoughtbythestatisticalanalysisteam,withregardstodatathatwasentered.Forpatientswithoutpassport/nationalidentificationdocuments,pleasegeneratearegistrationnumber,perhapsAAA-00001onwards(AAAbeingsiteID),andthenannotatingthisaccordinglyinthepatient'sfileaccordingtohospitalprocedure-forinstance"ThispatienthasbeenrecruitedfortheIGATESstudyandhasapatientregistrationnumberofAAA-00001".Thisistoavoidduplicateentriesforagivenpatient,andtofacilitatedatareviewshoulduncertainties,missingdata,orerrorsbeidentified.

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SensitivehealthinformationsuchasHIVstatusmustnotbeenteredintothewebplatform,unlessanexemptionisgrantedbythegoverningIRB.Allthisanonymiseddataofrecruitedpatientswillbekeptinapassword-protectedweb-basedmedium.Studyexcelsheetsaretobekeptinapasswordprotectedcomputer.Computersandbackupfilescontainingdatawillbekeptinsecuresite-basedlocations.Afterthedataentryiscomplete,theIGATESdataentryportalwillbeclosed.

5.0 Authorship Policy: TheauthorshipstyleforallpaperswillbetheModifiedConventionalstyle(namedauthors“for”thestudygroup,e.g.Jones,SmithandJohnson,“fortheInternationalGlobeandAdnexalTraumaEpidemiologyStudy”).Theentirestudygroup(definedasIGATESgroupinvolvedindatacollectionandanalysis)willbeacknowledgedinprimarypapers.Thesteeringcommitteewillmaintainacreditrosterupdatedperiodicallyforthispurpose.

5.1 Primary Manuscripts Primarymanuscripts(primaryreportsoftheepidemiology,clinicalfeatures,mortality,incidenceofcomplications,andoutcomes)willhavealltheIGATESparticipatingmemberslistedascontributingauthorsundertheIGATESgroupasperICMJEguidelines.

TheSteeringCommitteememberswillbethenamedauthorsinthemanuscripts.AnnetteHoskinand/orDr.DineshVisvaGunasekeranwillbethedefaultfirstauthorsandA/Prof.RupeshAgrawalwillbetheleadcorrespondingauthor.DependingonthecontributionfromthemembersoftheIGATESgrouptodatacollection,dataanalysisand/ormanuscriptpreparation,memberswillbeaddedasnamedauthorstomanuscripts,subjecttotargetjournals’authorshipcriteriaandinstructions.ContributingstudyteammembersnotincludedinanamedmanuscriptwillbeacknowledgedinthemanuscriptasmembersoftheIGATESgroup.Thenamesofalltheparticipatingcentreswillalsobeacknowledgedinprimarymanuscripts.

AnyparticipatingcentrecanapproachtheSteeringCommitteetoleadtheauthorshipofanyadditionalproposedmanuscriptutilisingthecompletedatabase.Thebiostatistician(s)conductingtheanalysiswillalsobeincludedasaco-author.Otherco-authorsmaybeincludedfollowingapprovalbytheSteeringCommittee.

5.2 Secondary Manuscripts Other(“secondary”)manuscriptscanbeinitiatedbyanycenter.Therearenolimitationsonwhomayserveasfirstauthorforasecondarymanuscript(e.g.acoreinvestigator,afellow,aresident,anotherfacultymember).Non-primarymanuscriptsmustbeproposedandapprovedbythestudySteeringCommittee.Itisanticipatedthatapprovaltypicallywillbegranted,butthatgoingthroughtheapprovalprocesswillavoidduplicationofeffort,willfacilitateallocationof(limited)centralresources(e.g.biostatisticiansupport)toindividualprojects,andmayimprovethequalityoftheproposeddesignoftheanalysistobe

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conducted.Afterapprovaltowriteamanuscriptisobtained,themanuscriptmustbesubmittedwithintwelvemonths,orapprovaltowritethemanuscriptmayberevoked,atthediscretionoftheSteeringCommittee.

Namedauthorswillinclude:theprimarywriterofthemanuscript(firstauthor),thestatisticianconductingtheanalysisforthepaper(ifapplicable),theleadPIoftheparticipatingcentre(correspondingauthor),theSteeringCommitteeandtheIGATESstudygroup(asperICMJEguidelines).AdditionalauthorsmaybenamedwithapprovaloftheSteeringCommitteewhenappropriate.Unlessagreedotherwise,the“seniorauthor”(listedlastinthenamedauthorslist)willbethepersonwhotakesonprimaryresponsibilityforassuringthequalityandcompletionoftheproject.Usuallythispersonwillbethesponsor,butanothercouldfulfilthisrolewhenappropriate.Thespecificauthorshipplanwillbeproposedatthetimeofproposalofthemanuscriptbythefirstauthor,basedontheanticipatedextentofcontributionofeachauthortothemanuscript,andissubjecttoapprovalbytheSteeringCommitteebasedontheguidelinesabove.Atthetimethemanuscriptiscirculatedforfinalapproval,co-authorswillhavetwoweekstorespondwiththeirsuggestionsandsign-offauthorshipdocuments.Thosewhodonotrespondwillbeomittedfromauthorshipforthatmanuscriptandacknowledgedascontributors.

Note:thestudyimposesnorestrictionuponacentre’sreportingofitsowndata.EachcentermayconductchartreviewstudiesinthesamemannerasiftheywerenotparticipatingintheIGATESproject.AnysitemayrequestdatacontributedfromthesitetotheIGATESplatformtobeprovidedbacktothecentreforthestudyteamtoreportitsowndata.Datawillbereturnedinexcelformatwithin2weeksofreceiptofthisemailrequest.

5.3 Meeting Presentation Policy: Abstractsmustbecirculatedatleast2weeksaheadofsubmissionsothatco-authorshaveanopportunitytocommentbeforesubmission.Co-authorsmayeitherreturncommentsormayindicateapprovalofthesubmissionbynotreturningcomments.Abstractsshouldnotbesubmittedunlessthefollowingrequirementsaremet:1)Finaltablesandfiguresarecompleted;2)Draftmanuscriptiscompleted(outlinedDiscussionisacceptable)

Conferencepresentationauthorshippolicy:Someconferencesmayrestrictthenumberofauthorscreditedinconferenceabstracts.Ifso,authornamesmaybeomittedintheabstractandinsteadacknowledgedasmembersoftheIGATESgroupinordertomeettheguidelinesandinstructionsoftheconference.However,allauthorsmustbeacknowledgedinthetalkorposterasmembersoftheIGATESgroupandcontributingauthorstothestudy.

Note:ConsultthestudyPIregardingauthorshiporderpriortocirculatingabstracts.

6.0 Data Entry 6.1 IGATES 1 ToenterdatainIGATES-1,selectachartfromJanuary2006tillDecember2015(oraportionofthisperiod),andconfirmthatthepatientdescribedinthechartiseligibleforthestudy.

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6.1.1 IGATES-1 Exclusion and inclusion criteria Inclusioncriteria:Seriousoculartrauma—definedas‘aninjuryorwoundtotheeyeoradnexacausedbyexternalforceorviolence,whichmayrequiresadmissiontohospital(howevernotlimitedtoonlyadmission)forobservationortreatment’.

ApatientispotentiallyELIGIBLEfortheIGATES1studyif(s)hehasofanyofthefollowingdiagnoses:

Χ Openglobeinjury(withorwithoutadnexalororbitalinvolvement)Χ IOFB

Allpatientswithaccidentalornon-accidentaleye(globeand/oradnexal)injuriesresultingintheabovediagnosisaretobeincluded.

Itisanticipatedthatpatientswillberecruitedthroughemergencydepartments,outpatientclinicsandfrominpatientreferrals.

ExclusionCriteria:ApatientisINELIGIBLEfortheIGATES-1studyif(s)he:

Χ Absenceofopenglobeinjury

QuestionsabouteligibilityshouldbereviewedwithyourcenterPIorcanbedirectedtoA/Prof.RupeshAgrawalorMs.AnnetteHoskin.

NOTE:Achartthathasbeenenteredshouldbe“marked”insomewaythatisnotobjectionableandisHIPAAcompliant,toavoidduplicateentries.ThesitePIisresponsibleforensuringthattherearenoduplicateentriesofindividualpatients.

6.2 IGATES 2

IGATES-2willbeprospectivearmofIGATES.SelectivecentreswhowillbeparticipatingactivelyforIGATES-1willbeidentifiedforIGATES-2.InIGATES-2,patientswillberecruitedfromthecommencementofthestudyforaperiod(tentativeJanuary2018)of5years.PatientstobeincludedinIGATES-2willincludeallpatientsthatmeettheinclusioncriteria.Patients/visitsafterthattimeshouldberecorded.Therewillbeocularschematicsformtofacilitateclinicaldetailsintheforminnon-ambigousway.IGATESteamisbuildinguptheocularschematicsbasedregistry.

6.2.1 IGATES-2 Exclusion and inclusion criteria and classification of Major or Minor Trauma Patientswillbeclassifiedashavingminorormajortraumadependingonthewhetheritispotentiallyvisionthreatening.Allthepatientswithhistoryofocularinjury(mechanicalornon-mechanical)willbeincluded.ThiswillincludeopenglobeorclosedglobeinjuryorlidoradnexaltraumawithoutglobeinjurycanbeincludedinIGATES2.

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MinortraumacaseswillbedefinedaspatientspresentingwithVAbetterthan6/18withandofthefollowing:

1. Cornealforeignbody2. Cornealabrasion3. Lamellarcorneallaceration4. Subconjunctivalhaemorrhage5. Traumaticiritisormicro-hyphema6. Berlin’soedema(retinalcommotion)7. SimpleLidlaceration(includingmargininvolvement)8. Anyformofminortraumanotinvolvingsurgery

Majortraumacaseswillbedefinedaspatientswithanyofthefollowing:

1. Openglobeinjury2. Closedglobeinjuryincludinghyphema(exclmicro),iridodialysis,anglerecession(withor

w/oglaucoma),cyclodialysiscleft,hypotonyorelevatedpressure,traumaticcataract,vitreoushaemorrhage,macularhole,choroidalrupture(withorw/oCNVM),orbitalfractures,complexlidlacerations(involvingcanaliculus),traumaticopticneuropathy,cranialnervepalsyrequiringinterventionVA6/18orlesssecondarytotraumaHospitalisationsecondarytoeyeinjuryNBMinortraumasrequiringsurgicalinterventionsasaresultofafurthercomplicationcanthenbere-classifiedtomajortrauma.

PopulationoftheIGATES-2studyform(shortorlong)willbebasedontheclassificationofmajororminortrauma.Irrespectiveofwhetheracaseismajororminortraumathepatientcanbeincludedineithertheshortorlongerform.Datawillbepresentedattimeofpresentationandatallfollowupappointments.

QuestionsabouteligibilityshouldbereviewedwithyourcenterPIorcanbedirectlyenquiredfromDrRupeshAgrawalorAnnetteHoskin.

NOTE:Inmostcases,achartthathasbeenenteredshouldbe“marked”insomewaythatisnotobjectionableandisHIPAAcompliant,toavoidwastingtimere-reviewingchartsthatalreadyhavebeenentered.

TheIGATESstudywillbeenrolledwithclinicaltrials.gov.

6.3 The IGATES Data System TheIGATESdatasystemwillbethemainrepositoryofdataateachsite.Eachsitewillusetheelectronicformfordataentrycreatedspecificallyforthisstudy.ThecentraldatabaseinMicrosoftexcelformwillbeonthecloudserverofcognitoplatformandcanbeaccessedbyProfRupeshAgrawalandthesteeringcommittee.

Apassword,giventoeachcentre,isrequiredtoopentheIGATESdatabase.Ifthereareproblemsopeningthedatabase,thefollowingpersonsmaybecontacted(inorder):

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Dr.DineshGunasekeran

E-mail:dineshvg@hotmail.sg

Ms.AnnetteHoskin

E-mail:annettehoskin@yahoo.com.au

A/ProfRupeshAgrawal

E-mail:Rupesh_agrawal@ttsh.com.sg

(AnewlinkbeprovidedforIGATES2willbeprovidedforselectedcentreforIGATES)

6.4 Data Entry TheDATAENTRYsectioninvolvesanonlineweb-baseddataaggregationplatform.Patientidentitywillbekeptconfidential,andpersonalinformationwillnotbeenteredintotheonlinedatabase.Thedatafromeverysitewillbestoredatasinglesecureserver,anddifferentsitesshallnotbeabletoaccesseachother’sdatasheetsuntiltheendofthestudy.Achartthathasbeenenteredshouldbe“marked”inamannerthatisHIPAAcompliant,toavoidduplicationofchartreviews.

IGATESpatientswillbeidentifiedbytheCountryCode,SiteIDandcodedPatientID.SiteIDisuniquetoeachparticipatinghospitalandwillcorrespondthecountryandhospitalthepatientwasreviewedatfortheInitialPresentation.ThecodedPatientIDwillbetakenasthelast5charactersofthepatients’NationalIdentificationnumber.Forexample,apatientwithIdentificationnumberof“S9230202C,”willhaveaIGATESPatientIDof“0202C”.PleasedirectanyuncertaintiesregardingthistoAnnetteHoskin,shecanbecontactedviaemailatannettehoskin@yahoo.com.au.

IGATES-1web-baseddataaggregationplatform:

https://www.cognitoforms.com/Eye11/IGATES1

6.4.2 Entering Data from Medical Records IMPORTANT:Beforeenteringdataonapatientatinitialpresentation,pleaseconfirmthatthepatientiseligibleforthisstudy,basedontheinclusionandexclusioncriteriadetailedabove.

GeneralRulesforEnteringDatafromChartReviews:

ProcedureforDataentry:

YouwillfindthattheonlineIGATESformisintuitiveanduserfriendly.

Pleaseenterinformationaccordingtothequestionspresentedtoyoubytheform,whichareself-explanatory.Ifinformationnecessarytoanswerapromptedquestionisnotavailabletoyou,pleaseselect“Unknown”.

TheIGATESformiscomprehensivetoprovidethenecessarydataforhighqualitypublications.Ithasbeenprogrammedasasmartformandtestedinseveralroundsoftrialrunstominimizeunnecessarydataentry.Assuchithasbeenoptimizedtochangethequestionspresentedtotheuserbasedonhisrepliestoearlierquestions.Abasicexample:iffor“Laterality–EyeInvolvement”youselect“OD(Righteye)”,youwillnotbepromptedtoenterdatafortheOS(Lefteye).Ifyouselect“Botheyes”,youwillbepromptedtoenterclinicaldataforbotheyes.

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Pleasebearinmindthatonceaformissubmitted,thedatawillbesavedinaremoteandsecurelocation,andcannotbere-accessedforedits.Assuchplease“Save”inanysituationofuncertainorincompletedataentry.Thenextsectionhighlightsprocedureforanydataentryerrors/changes.

Theformallowsyoutosaveprogressandresumedataentrylater.Simplyclickthe“Save”buttonatthebottomofthecurrentpagetodoso.Youwillbepromptedtoenteranemail,towhichauniquelinktoresumethecurrentformwillbesent.PleasechecktheSiteIDandPatientIDbeforeyouresumeenteringdataintotheform,tominimizeerrors/prevententeringdataintothewrongform.

Pleasebearinmindthatonceaformissubmitted,thedatawillbesavedinaremoteandsecurelocation,andcannotbere-accessedforedits.Assuchplease“Save”inanysituationofuncertainorincompletedataentry.

Ifyoushouldneedtoeditthedatainasubmittedform,pleaseinformthedataadministratorAnnetteHoskin,annettehoskin@yahoo.com.au,andthenre-enterthedataforthepatientinanentirelynewIGATES-1form.Theoriginaldatawillbeomittedfromanalysistoavoiddataentryerrors.

Procedureforenteringdates:

DatesareenteredusingthevirtualcalendarsembeddedwiththerelevantquestionsontheIGATESform.Besuretochecktheyearonthecalendarbeforeselectingthemonthandday.

Ifonlytheyearisknownbasedonmedicalrecord,pleaseenterthedateas1stofJanuaryforthatyeari.e.for“diagnosedin2011”thedatewillbe“01/01/2011”.Ifonlyarangeofyearsisknownbasedonmedicalrecord,pleaseenterthedateasthemidpointi.e.for“diagnosedin2007-2008”thedatewillbe“01/01/2008“.Thesameappliesforwiderrangesofyearsi.e.for“diagnosedin2007-2011”thedatewillbe“01/07/2009”.Ifonlythemonthisknown,enterdateasthefirstofthatmonthi.e.for“diagnosedinMay2011”thedatewillbe“01/05/2011”.

Ifthedate,month,andyearareallnotavailable,pleaseenterdateas29/11/1111.

ProcedureforenteringVisualAcuity

Pleaseselectfromtheoptionsinthedrop-downmenuprovided.

ProcedureforenteringClinicalFindings

SeeAnnex2(thisisprovidedanoverviewonly)

Procedureforsubmittingclinicalphotos

ThiswillbepromptedbytheIGATESformateveryclinicalvisit

Ifavailable,pleaseuploadthephotoin.jpegor.jpgformats(don’tupload.tiffphotosduetotheheavyimagesize).Pleasealsoaddadescriptionintheopen-endedsectionbelowthephotoontheclinicalfindingsimage.Thephotoswillbeusedtocreatedatabaseofoculartraumaandforeducationandresearchpurpose.

Annexure1:Participatingcentres

Annexure2:IGATESStudyForm(overview)