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correctionforthefirst timeuallychallengingenvironmeat night in
rainy/foggyconessaryforthepatient toreof clearnearvisionand
stcontact lensesprovide.
B. Eye SelectionGenerally,thenon-domina
twomethodsforeyedom
1. OcularPreference
Method1: Determinepoint toanthepatienusedisthe
Method2:
Determineleastreducthespectacwhilethedbotheyes.thenearAD
Other methodsincludedemandsmethod.
2.Refractive ErrorM
For anisometropiccorrhyperopic(lessmyopi
hyperopic)eye for nea
3.VisualDemandsMConsider thepatientsdeterminethe
criticalvtasksisusuallyinone
Example: A secretary
functionbesC. SpecialFitti ng Chara
1.UnilateralLensCTherearecircumstanc
example,anemmetrobilateralmyopemayon
Example: Apresbyopicwouldhavea
Thefittingindicatesthefollowing:
RightEyeCompensatethe10axisdrift byaddingitto themanifest
refractionaxis.Hereisthe Rxprescribed:O.D.3.000.75x100
LeftEyeThelensonthe lefteyeshowsgoodcentration,movement
andaconsistenttendencyforthe marktodrift rightby10 from the6
oclockpositionfollowinga forcedblink.Sincethemanifest
refractioncalledfora powerof 4.75D,adjust
forthevertexdistanceandreducethesphereby0.25D
andprescribethe1.75Dcylinder.Compensateforthe10axis drift by
subtractingit from the mani-fest refraction.Hereis
theRxprescribed:
O.S.4.501.75x80
If visionis acceptable,perform aslit lampexamination toassess
adequatefit(centrationandmovement).Iffit
isacceptable,dispensethelensesinstructingthepatienttoreturninoneweekfor
reassessment(seedispens-
ingandfollowupinformationin PATIENTMANAGEMENT).
IV.MULTIFOCAL FITTINGGUIDELINESA.Presbyopic NeedsAssessment
&Patient EducationMultifocalcontact
lensesmayproducecompromiseto
visionundercertaincir-cumstancesandthepatientshouldunderstandthat
theymightnot findtheirvisionacceptablein specific
situations(i.e.,readingamenuin adim restaurant,drivingat night
inrainy/foggy conditions,etc.). Therefore,caution
shouldbeexercisedwhenthepatient iswearingthecorrectionforthefirst
timeuntiltheyarefamiliarwiththevisionprovidedinvisuallychallengingenvironments.Occupationalandenvironmentalvisualdemandsshouldbeconsidered.If
thepatient requirescriticalvisualacuityandstereopsis,it shouldbe
determinedbytrialwhetherthispatient canfunctionadequatelywiththe
ACUVUE OASYS
BrandContact Lenses forPRESBYOPIA withHYDRACLEAR PLUS.TheACUVUE
OASYS BrandContact Lenses forPRESBYOPIA withHYDRACLEAR
PLUS wearmaynot beoptimalforsuchactivitiesas:
1.visuallydemandingsituationssuchasoperatingpotentiallydangerousmachineryor
performingother potentiallyhazardous
activities;and2.drivingautomobiles(e.g.,drivingat
night).Patientswhocannot passtheir
statedriverslicenserequirementswiththeACUVUE OASYS BrandContact
Lenses forPRESBYOPIA shouldbeadvisedto not
drivewiththiscorrection,OR mayrequire that
additionalover-correction beprescribed.
ACUVUE OASYS BrandContact Lenses forPRESBYOPIA arenot
recommend-edforpatientswhohave1.00D orgreaterofrefractivecylinderas
thislevel
ofuncorrectedcylindermaylead toadditionalvisualcompromise.
TheACUVUE OASYS BrandContact Lenses forPRESBYOPIA
withHYDRACLEAR
PLUS comeinthe followingADD powers:LensLOW=lownearADD
lens(Max+1.25ADD)LensMID= mediumnearADD lens (Max+1.75ADD)LensHGH=
highnearADD lens (Max+2.50ADD)
B.The ACUVUE OASYS Brand ContactLenses
forPRESBYOPIAContactFitting Instructions
S te p 1 De te rm in e:-
Eyedominance(themethodsdescribedinMONOVISION
SPHEREAND TORIC FITTINGGUIDELINES maybe used)-
Sphericalequivalent distanceprescription (vertexcorrected if
neces-
saryandroundedtolessminusif betweenpowers)- NearADD
Step2 Se lect the ini t ia l t r i al l ensas fo llows :-
Foreacheye select the triallensdistancepowerthat isclosest
tothe
patientsdistance sphericalequivalent.Selectthe nearpowerof
thelensbasedonthe patientsADD rangeasfollows:ADD: +0.75 to+1.25
usea LOWnear ADD lenson eacheyeADD: +1.50 to+1.75 usea MIDnear ADD
lenson eacheyeADD: +2.00 to+2.50 usea HGHnear ADD lenson
eacheye
S tep3 A l low the lens to se t t le fo ramin imum
10minutes.
S tep4 - Assessd istanceandnearv is ionb inocu lar l yandmonocu
la r ly .- Demonstratethe visionunder variouslighting
conditions
(normaland decreasedillumination) andat distance,intermediateand
near.
- Makeadjustmentsin powerasnecessary(see
MultifocalTroubleshootingbelow).Theuseof
hand-heldtriallensesisrecommended.
- Ifdistanceandnearvisionareacceptable,perform a slit
lampexami-nationto assessadequate fit (centrationand movement).If
fit is
acceptable,dispensethelensesinstructingthepatient
toreturninoneweekforreassessment
(seedispensingandfollowupinformationinPATIENT MANAGEMENT).
C.Multifocal Troubleshooting
UnacceptableNear Vision:
Determinetheamount of
additionalplus,orlessminus,overoneorbotheyesthat
isacceptablewhilecheckingtheeffect on distanceandnearvision. If
visionis stillnotacceptablechange thenon-dominant eyeto thenext
highest ADD power.
UnacceptableDistance Vision:
Determinetheamount of additionalminus,or
lessplus,overoneorbotheyesthat is acceptablewhilecheckingtheeffect
on distanceandnearvision. If visionisstillnot
acceptablechangethedominant eyetothe next lowest ADD power.
Ifthepatient iswearingtwolowADD lenseschangethedominant eyetoa
spherelenswithapowerequalto thesphericalequivalent
distanceprescription.
UnacceptableDistance andNear Vision:
Determinetheamount of
additionalplusand/orminusoveroneorbotheyesthatisacceptablewhilecheckingtheeffect
on distanceandnearvision. If additionalplusand/orminusisnot
requiredchangethelenspowerinthedominant eyetothenext lowest ADD
powerandthelenspowerin thenon-dominant eyetothenext highest ADD
powerif applicable.
V.MONOVISION( SPHERICALAND TORICFITTING GUIDELINES)
A.PatientSelectionMonovision
NeedsAssessmentForagoodprognosis,thepatient
shouldhaveadequatelycorrecteddistanceandnearvisualacuityineacheye.Theamblyopicpatient
orthepatient withsignificant astigmatism (greaterthan1.00D)
inoneeye maynotbea
goodcandidateformonovisioncorrectionwiththeACUVUE OASYS
BrandContactLenses, theACUVUE OASYS BrandContactLenses
forASTIGMATISMorthe ACUVUE OASYS BrandContactLenses
forPRESBYOPIA.
Occupationalandenvironmentalvisual demandsshouldbe
considered.Ifthepatientrequirescritical vision(visualacuity
andstereopsis),it shouldbedeterminedbytrial whetherthispatient
canfunction
adequatelywithmonovisioncorrection.Monovisioncontactlens wearmay
notbe optimalforsuch activitiesas:
(a)visuallydemandingsituationssuchasoperatingpotentiallydangerousmachineryor
performingother potentiallyhazardous activities;and
(b)drivingautomobiles(e.g.,drivingat night).Patientswhocannot
passtheirstatedriverslicenserequirementswithmonovisioncorrectionshouldbeadvisedto
not drivewiththiscorrection,OR mayrequirethat additional
over-correctionbe prescribed.
Patient EducationAllpatientsdo notfunctionequallywellwith
monovisioncorrection.Patientsmaynotperformas wellforcertaintasks
withthiscorrectionas theyhavewith
specta-cles(multifocal,bifocal,trifocal,readers,progressives).Eachpatientshould
under-standthatMonovision,aswell
asotherpresbyopicalternatives,cancreatea
visioncompromisethatmayreducevisual acuityanddepth perceptionfor
distanceandneartasks.Therefore,cautionshouldbeexercisedwhenthe
patientiswearingthe
4.With thebiomicroscope,judgethe lensfitting
characteristics(asdescribedintheGeneralFittingGuidelines)andevaluatethelenssurfacefordepositsand
damage.
5.Following lensremoval,examinethe corneaandconjunctivawith
thebiomicroscopeand fluorescein(unlesscontraindicated).
The presenceofverticalcornealstriae inthe
posteriorcentralcorneaand/orcornealneovascularizationis
indicativeofexcessivecornealedema.
The presenceofcornealstainingand/or
limbal-conjunctivalhyper-emiacan beindicativeof anuncleanlens,
areactionto solutionpreservatives,excessivelenswear and/orapoorly
fittinglens.
Papillaryconjunctivalchangesmay beindicativeof
anuncleanand/ordamagedlens.
6.Periodicallyperformkeratometryand
spectaclerefractions.Thevaluesshouldbe recordedandcomparedto
thebaselinemeasurements.
Ifany observationsareabnormal, useprofessionaljudgment
toalleviatetheproblemandrestoretheeyetooptimalconditions.Ifthecriteriafor
successfulfitare notsatisfied duringany
follow-upexaminations,repeatthepatientstrialfittingprocedureandrefitthepatient.
WEARINGSCHEDULE
ThewearingandreplacementschedulesshouldbedeterminedbytheEye
CareProfessional.Patientstendtooverwear thelensesinitially.TheEye
Care
Professionalshouldemphasizetheimportanceofadheringtothe
initialmaximumwearingschedule.Regularcheckups,asdeterminedbythe
EyeCareProfessional,arealso extremelyimportant.
DailyWear(lessthan 24 hours,whileawake) For DailyWear,VISTAKON
recommendsthat theACUVUE OASYS Brand
Contact Lenseswith HYDRACLEAR PLUS (senofilconA), ACUVUE
OASYS
Brand Contact Lenses forASTIGMATISM with HYDRACLEAR
PLUS(senofilcon A)or ACUVUE OASYS BrandContact Lenses
forPRESBYOPIAwithHYDRACLEAR PLUS (senofilconA) prescribedfor
frequentreplacementwear bediscarded and replaced with anew
lensevery 2weeks. However,theEyeCareProfessionalisencouraged
todeterminean appropriatelensreplacement schedulebased upon
theresponse of thepatient.
When prescribed fordisposable wear, theACUVUE OASYS
BrandContactLenseswith HYDRACLEAR PLUS (senofilconA),ACUVUE OASYS
BrandContact Lenses forASTIGMATISM with HYDRACLEAR PLUS
(senofilconA)and ACUVUE OASYS BrandContact Lenses forPRESBYOPIA
withHYDRACLEAR PLUS (senofilconA) shouldbe discardedupon
removal.
axes,such as when the diagnostic lens axis is different from the
patientsrefractive axis,it is not advisable to over-refract because
of the difficultyin computing the resultant power.
In fitting contact lenses,it is customary to prescribe the full
power in thesphere.Inthe cylinder,however,anylensrotation
isvisually disturbingtothepatient,soits morepracticalto
prescribeasweak acylinderas possible.
So,here is how to determine the final lens power.
Fort he Sphere:Ifsphere aloneor combinedsphereand cylinderRx
>4.00D,compen-satefor vertexdistance.If spherealoneor
combinedsphereandcylinderRx0.25Dfrom therefractive cylinder.
Case ExamplesExample
1Manifest(spectacle)refraction:O.D.2.50-1.25x18020/20O.S.2.00-1.00x18020/20
Chooseadiagnosticlensforeacheyewithanaxisascloseto180aspossible.Placethelenson
eacheyeandallowaminimumof3 minutesforit
toequilibrate,basedonthepatientsini-tialresponsetothelens.
Checktheorientationoftheaxismark.Ifthebottomaxismarkisinthe6
oclockpositionon botheyes,choose theappropriatecylinderaslisted
previously.
Hereis theRx
Prescribed/Ordered:O.D.-2.50-1.25x180O.S.2.00-0.75x180
Example 2Manifest (spectacle) refraction:O.D. 3.00 -1.00 x 90
20/20O.S. 4.75 -2.00 x 90 20/20
Choosediagnosticlensesof3.000.75x90
fortherighteyeand4.50-1.75x90
forthelefteye,thenearestlensesavailabletothesphericalpowerandaxisneeded.Placethelensoneacheyeandallowa
minimumof3
min-utesforittoequilibrate.Theorientationmarkontherightlensrotatesleftfromthe6oclockpositionby10.
PATIENT MANAGEMENT
Dispensing Visit PROVIDETHEPATIENTWITHACOPYOFTHE ACUVUE OASYS
BrandContact
Lenseswith HYDRACLEAR PLUS (senofilconA), ACUVUE OASYS
BrandContactLenses forASTIGMATISM withHYDRACLEAR PLUS (senofilconA)
orACUVUE OASYS BrandContact Lenses forPRESBYOPIAwithHYDRACLEAR
PLUS
(senofilconA)PATIENTINSTRUCTIONGUIDE.REVIEWTHESEINSTRUC-TIONSWITHTHEPATIENTSOTHATHE
ORSHECLEARLYUNDERSTANDSTHEPRESCRIBEDWEARINGANDREPLACEMENTSCHEDULE(DISPOSABLEORFREQUENTREPLACE
MENT).
Recommend an appropriate cleaning and disinfecting system and
providethe patient with instructions regarding proper lens
care.Chemical orhydrogen peroxide disinfection is recommended.
Schedule a follow-up examination.
Follow-up Examinations
Follow-upcare(necessarytoensurecontinuedsuccessfulcontactlenswear)
shouldincluderoutineperiodicprogressexaminations,managementof
specificproblems,if any,anda reviewwiththepatient ofthe
wearschedule,lensreplacementscheduleandproper lenscareand
handlingprocedures.
Recommended Follow-up Examination Schedule for ACUVUE OASYS
Brand Contact Lenses with HYDRACLEAR PLUS (senofilcon
A),ACUVUE
OASYS BrandContact Lenses forASTIGMATISM withHYDRACLEAR
PLUS (senofilconA) or ACUVUE OASYS Brand Contact Lenses
forPRESBYOPIA with HYDRACLEAR PLUS (senofilcon A) (complications
and
specific problems should be managed on an individual patient
basis):1.One week from the initial lens dispensing to patient2.One
month post-dispensing3.Every three to six months thereafter
NOTE:More frequent or additional follow-up visits may
berecommended for patients on an extended wear schedule.
Preferably,atthe follow-upvisits,lensesshouldbe wornforat
leastsixhours.Ifthe lensesarebeing wornforcontinuouswear,the
examinationshould beperformedasearlyas possibleonthe
morningfollowingovernightwear.
Recommended Procedures for Follow-Up Visits:1.Solicit and record
patients symptoms,if any.2.Measure visual acuity monocularly and
binocularly at distance and near
with the contact lenses.3.Perform an over-refraction at distance
and near to check for residual
refractive error.
The maximum suggested wearing time for these lenses is:DAY
HOURS1 6-82 8-103 10-124 12-145 and after all waking hours
Extended Wear (greater than 24 hours, including while asleep)
TheEye CareProfessional should determinethe wearingand replacement
schedule,
baseduponthepatientshistoryandtheirocularexamination,aswellas
thepracti-tionersexperience andclinical judgment.
ACUVUE OASYS BrandContact Lenseswith HYDRACLEAR PLUS
(senofilconA),ACUVUE OASYS BrandContact Lenses forASTIGMATISM
withHYDRACLEAR
PLUS (senofilconA) or ACUVUE OASYS BrandContact Lenses
forPRESBYOPIAwithHYDRACLEAR PLUS
(senofilconA)havebeenapprovedforextendedwearforupto 6nights/7
daysof continuouswear.Not allpatientscanachievethemaxi-mum wear
time.
It isrecommendedthatthecontact lenswearerfirst beevaluatedon
adailywearschedule. Ifsuccessful,thena gradualintroductionof
extendedwearcanbefollowedasdeterminedbytheprescribingEyeCareProfessional.
Onceremoved,itisrecommendedthat thelensremainout of the eyefora
periodofrestovernight orlonger anddiscardedin
accordancewiththeprescribedwearingschedule.
TheEyeCareProfessionalshouldexaminethepatient
duringtheearlystagesof extendedwear.
ForT herapeutic lenswear,closesupervisionbytheEye
CareProfessionalis neces-sary.ACUVUE OASYS BrandContact Lenseswith
HYDRACLEAR PLUS (senofilcon
A),ACUVUE OASYS BrandContact Lenses forASTIGMATISM
withHYDRACLEAR
PLUS (senofilconA) or ACUVUE OASYS BrandContact Lenses
forPRESBYOPIAwithHYDRACLEAR PLUS (senofilconA)canbewornfor
extendedwearforup to6nights/7
daysofcontinuouswear.TheEyeCareProfessionalshoulddeterminetheappropriatewearingtimeandprovidespecificinstructionstothe
patient regardinglenscare,insertionandremoval.
LENS CARE DIRECTIONS
Whenlensesaredispensed,theEyeCareProfessionalshouldprovidethepatient
withappropriateand adequatewarningsandinstructionsin
accordancewiththeindividualpatientslenstypeandwearingschedule.
TheEyeCareProfessionalshouldrecom-mendan appropriatecare system
tailoredto thepatients individualrequirements.
Forcomplete informationconcerning contact lenshandling,
care,cleaning, disinfectingandstorage,refertothe ACUVUE OASYS
BrandContact Lenseswith HYDRACLEAR
PLUS (senofilconA),theACUVUE OASYS BrandContact Lenses
forASTIGMATISMwithHYDRACLEAR PLUS (senofilconA)andtheACUVUE OASYS
BrandContact
Lenses forPRESBYOPIA withHYDRACLEAR PLUS (senofilconA)
PatientInstructionGuide forDisposable & Frequent Replacement
Lenses.
ForACUVUE OASYS BrandContact Lenseswith HYDRACLEAR PLUS
(senofil-conA),ACUVUE OASYS BrandContact Lenses forASTIGMATISM
withHYDRACLEAR PLUS (senofilconA)andACUVUE OASYS BrandContact
LensesforPRESBYOPIA withHYDRACLEAR PLUS (senofilconA) prescribed
fordisposablewear :TheEyeCare
Professionalshouldreviewwithpatientsthat nocleaningordisinfectionis
neededwithdisposablelenses.Patientsshouldalwaysdisposeof
lenseswhentheyare removedandhavereplacement
lensesorspectaclesavailable. Lensesshouldonlybe
cleaned,rinsedanddisinfectedonanemergency basiswhen replacement
lensesor spectaclesare not available.
ForACUVUE OASYS BrandContact Lenseswith HYDRACLEAR PLUS
(senofil-conA),ACUVUE OASYS BrandContact Lenses forASTIGMATISM
withHYDRACLEAR PLUS (senofilconA)andACUVUE OASYS BrandContact
LensesforPRESBYOPIA withHYDRACLEAR PLUS (senofilconA) prescribed
forfre-quentreplacement wear:EyeCareProfessionalshouldreviewwiththe
patient,lenscaredirectionsforcleaning,disinfectingandstoring,includingbothbasiclenscareinformationandspecificinstructionsonthe
lenscareregimenrecommendedfor thepatient.
Care forsticking (non-moving)lensesIfthe lenssticks
(stopsmoving), thepatient should beinstructed to applyafewdrops
ofthe recommended lubricating orrewetting solution
directlytotheeyeand waituntil thelensbeginsto movefreelyon
theeyebeforeremoving it. Ifnon-movement ofthe lenscontinues aftera
fewminutes, thepatientshould immediatelyconsult theEye
CareProfessional.
EMERGENCIES
Thepatient shouldbe informedthat if chemicalsof anykind
(household
products,gardening solutions,laboratory chemicals,etc.)
aresplashed intotheeyes, thepatient should:FLUSHEYES
IMMEDIATELYWITH TAPWATER ANDIMMEDIATELYCONTACTTHE EYECARE
PROFESSIONALOR VISITA HOSPITAL
EMERGENCYROOM WITHOUTDELAY.
HOWSUPPLIED
Eachsterilelensis suppliedin
afoil-sealedplasticpackagecontainingbufferedsalinesolutionwithmethylethercellulose.Theplasticpackageismarkedwithbasecurve,
diopterpower,diameter, color(visibility tint
notedonvisibilitytinted product only),lot numberand expirationdate.
[ADD power,
cylinderandaxiswillbe includedasappropriate].
Johnso75J
REPORTI
Allserious adverseexperience
wearingACUVUE OASYS Bra(senofilconA), ACUVUE OASY
HYDRACLEAR PLUS (senofiLenses forPRESBYOPIA
witencedwiththelensesshould
7/31/2019 AOfA-pi
2/2
havebeenapprovedfordaouswear. Itisrecommdailywear schedule.
Ifsucbefollowed asdetermined
TheACUVUE OASYS BraLenses
forASTIGMATISMPRESBYOPIAarealsoindfollowingacuteand chroni
Forcornealprotectionintarsalscarsand recurretionwheresutures
orocresultin theneedto pro
Forcornealpain reliefinandabrasion,filamenta
Foruseasabarrierduchronicepithelialdefectandchemicalburns.
Forpostsurgicalcondrefractivesurgery,lameconditions.
Forstructuralstabilityanandassociatedsurfaces(RGP)lensestobefit.
Iabrasionsinconditions
junctionor scartissue.
Lensesprescribedfortheperiods.
CONTRAI
Whenprescribingcontact ltheACUVUE OASYS BranLenses
forASTIGMATISMPRESBYOPIAwhenany o
Acuteorsubacuteinflam Anyeyedisease,inju Severeinsufficiencyofla
Cornealhypoesthesia(re Anysystemicdiseaseth
contactlenses Allergicreactionsofoc
exaggerated bywearin
Alwayshandlelenses carefullyandavoid droppingthem.
Neverusetweezersorothertoolstoremovelensesfrom
thelenscontainerunlessspecifically indicated forthat use. Pour
thelens andthe packingsolutionintothehand.
Donottouchthelenswithfingernails.
CloseSupervisionisnecessaryfortheTherapeutic useof theACUVUE
OASYS
BrandContact Lenses,the ACUVUE OASYS BrandContact Lenses
forASTIG-MATISM andtheACUVUE OASYS BrandContact Lenses
forPRESBYOPIA .Ocular medicationsused during treatmentwith abandage
lensshould becloselymonitored bytheEyeCareProfessional.
Incertainocularconditions,onlytheEyeCare Professionalwill insert
and removethe lenses. In thesecases, patientsshould beinstructed
not tohandlethe lensesthemselves.
LensWearing Precautions:
Ifthelenssticks(stopsmoving)ontheeye,followtherecommendeddirectionsin
"Carefora StickingLens". Thelensshouldmovefreelyon
theeyeforthecontin-uedhealthofthe eye.
Ifnon-movementofthelenscontinues,thepatientshouldbeinstructed
toimmediatelyconsult hisor herEye CareProfessional.
NeverwearlensesbeyondtheperiodrecommendedbytheEyeCareProfessional.
Ifaerosolproducts,suchashairspray,areusedwhilewearinglenses,exercisecautionand
keepeyesclosed untilthe sprayhas settled.
Avoidall harmfulor irritatingvaporsand fumeswhile
wearinglenses.
Askthe EyeCare Professionalaboutwearinglenses
duringsportingactivities,especiallyswimmingand otherwater sports.
Exposingcontactlenses towaterduringswimmingorwhilein
ahottubmayincreasetheriskofeyeinfectionfrom
microorganisms. Afterthe recommendedwearing
schedule,alwaysdiscardlensesworn ona dispos-
ableor frequentreplacementscheduleasprescribedby theEye
CareProfessional.
Solution Precautions:
Differentsolutionscannotalwaysbeusedtogetherandnotall
solutionsare
safefor usewith alllenses. Useonly recommendedsolutions.
Neverusesolutionsrecommendedfor
conventionalhardcontactlensesonly.
Chemicaldisinfectionsolutionsshould notbe usedwith
heatunlessspecificallyindicatedon productlabelingfor usein bothheat
andchemicaldisinfection.
Alwaysusefr esh,unexpiredlens caresolutionsand lenses.
Donot changesolutionwithout consultingwithyour EyeCare
Professional.
Alwaysfollowdirectionsinthepackageinsertsforthe
useofcontactlenssolutions.
Useonlyachemical(notheat)lenscaresystem. Useofa
heat(thermal)caresystemcandamage theACUVUE OASYS
BrandContactLenses,the ACUVUE
OASYS BrandContactLenses forASTIGMATISM andthe ACUVUE OASYS
BrandContactLenses forPRESBYOPIA.
Sterileunpreservedsolutions,when used,shouldbe discardedafterthe
timespecifiedin thedirections.
Donotusesalivaoranythingotherthantherecommendedsolutionsforlubricatingor
wettinglenses.
Alwayskeepthe lensescompletelyimmersedin
therecommendedstoragesolutionwhenthe lensesarenot beingworn
(stored). Prolongedperiodsofdryingwillreducetheabilityofthe
lenssurfacetoreturntoa
wettablestate.Followthelenscaredirectionsin"CareForADriedOut(Dehydrated)Lens"iflenssurface
doesbecomedried out.
LensCase Precautions: Contactlensescanbe
asourceofbacterialgrowthandrequireproperuse,
cleaningandreplacementat regularintervalsas recommendedby
thelenscasemanufactureror EyeCareProfessional.
OtherTopicsto Discusswith Patients:
AlwayscontacttheEyeCareProfessionalbeforeusinganymedicinein
theeyes.
Certainmedications,such
asantihistamines,decongestants,diuretics,musclerelaxants,tranquilizersandthose
formotion sicknessmaycausedryness oftheeye,
increasedlensawarenessor blurredvision.
Shouldsuchconditionsexist,proper remedialmeasuresshouldbe
prescribed. Dependingontheseverity,thiscould includethe useof
lubricatingdropsthat areindicatedforusewith softcontactlenses orthe
temporarydiscontinuanceof contactlenswearwhile suchmedicationis
beingused.
Oralcontraceptiveuserscould developvisualchangesor
changesinlenstolerancewhenusingcontactlenses.
Patientsshouldbecautionedaccordingly.
Aswithanycontactlens,follow-upvisitsarenecessarytoassurethecontinuinghealthof
thepatient'seyes. Thepatient shouldbeinstructed
astoarecommendedfollow-up schedule.
Who Should Know Thatthe Patientis Wearing ContactLenses?
Informthedoctor(HealthCareProfessional)aboutbeingacontactlenswearer.
Alwaysinformtheemployerofbeingacontactlenswearer.
Somejobsmayrequireuseofeyeprotectionequipmentormayrequirethatthepatientnotwearcontactlenses.
ADVERSE REACTIONS
Thepatient shouldbe informedthat
thefollowingproblemsmayoccurwhenwearingcontact lenses:
Theeyemayburn,stingand/oritch.
Theremaybelesscomfortthanwhenthelenswasfirstplacedontheeye.
Theremaybe afeelingofsomethingintheeye
(foreignbody,scratchedarea).
Theremay bethe potentialforsome temporaryimpairmentdueto
peripheralinfiltrates,peripheralcornealulcersand cornealerosion.
Theremaybe thepotentialforother physiologicalobservations,such
aslocal
orgeneralizededema,cornealneovascularization,cornealstaining,
injection,tarsalabnormalities,iritisandconjunctivitis,some ofwhich
areclinicallyacceptablein lowamounts.
Theremaybeexcessivewatering,unusualeyesecretions,orrednessoftheeye.
Poorvisualacuity, blurredvision,rainbowsor
halosaroundobjects,photo-phobia,ordryeyesmayalsooccurifthelensesareworncontinuouslyorfortoolongatime.
Thepatient shouldbe instructedtoconduct asimple
3-partself-examinationatleastoncea day. Theyshouldask
themselves:
Howdo thelensesfeelonmy eyes?
Howdo myeyeslook?
HaveInoticeda changeinmy vision?
Ifthepatientreportsanyproblems,heorsheshouldbeinstructedtoIMMEDIATELYREMOVE
THELENS.
Ifthediscomfortorproblemstops,thepatientshouldthenlookcloselyatthelens.
Ifthelensisin
anywaydamaged,thepatientSHOULDNOTputthelensbackontheeye.
Thepatientshoulddiscardthelensandapplyanewfreshlensontheeye.
Ifthelenshasdirt,aneyelash,orforeignbodyonit,ortheproblemstopsandthelensappearsundamaged,heor
sheshouldbeinstructedtodisposeofthelensandapplyanewfreshlens.
Iftheproblemcontinues,thepatientSHOULDNOTputthelensbackontheeyebutIMMEDIATELYCONSULTHISOR
HEREYE CAREPROFESSIONAL.
ThepatientshouldbeinstructedNOTtouseanewlensas
self-treatmentfortheproblem.
The patient should be advised that when any of the above
symptoms occur,aserious condition such as infection,corneal ulcer,
neovascularization or iritismay be present. He or she should be
instructed to seek immediate professionalidentification of the
problem and prompt treatment to avoid serious eye damage.
C.InitialPowerDetAspectaclerefractionrefractivestatusand
tRememberto compe4.00D.
D.Base Curve SeleFortheACUVUE OASYLensshouldbe
selecings.However,corneestablishthepatientsContactLenses
forASTforPRESBYOPIA,theablebasecurves.
ACUVUE OASYS BraLenses forASTIGMATPRESBYOPIA shouldbafter
thepatienthasad
1.Criteriaof aProAproperly fit lenswlimbalexposure),hthecontact
lenswfreelywhenmanipproperlycenteredppushingthelensubedispensed
tothe
2.Criteria of a FlatAflat fitting
lensmdecentration,incomexcessivemovemeOASYS BrandConASTIGMATISM
orPRESBYOPIA isjuthepatient.
3.Criteriaof aSte
AsteepfittinglensinsufficientmovemewhenpushingtheleBrandContactLensTISM
ortheACUVUtobe steepfitting,it
IftheinitialACUVUBrandContactLens
ACTIONS
Intheir hydratedstate,the ACUVUE OASYS BrandContactLenses,the
ACUVUE
OASYS BrandContactLenses forASTIGMATISM andthe ACUVUE OASYS
BrandContactLenses forPRESBYOPIA,whenplacedonthecornea,actasa
refractingmediumto
focuslightraysontheretina.Whenhydratedandplacedon
thecorneafortherapeuticuse, theACUVUE OASYS BrandContactLenses,the
ACUVUE
OASYS BrandContactLenses forASTIGMATISM andthe ACUVUE OASYS
BrandContactLenses forPRESBYOPIA actasa
bandagetoprotectthecornea.
Thetransmittancecharacteristicsarelessthan1%intheUVB
rangeof280nmto315nmandlessthan10%intheUVArangeof
316nmto380nmfortheentirepowerrange.
Note:Long-termexposureto UVradiationisoneof
theriskfactorsassociatedwithcataracts.Exposureisbasedonanumberoffactorssuchasenviron-mentalconditions(altitude,geography,cloud
cover)and personalfactors(extentand natureof outdooractivities).UV
blockingcontactlenses helpprovideprotectionagainst harmfulUV
radiation.However,clinicalstudieshavenotbeendonetodemonstratethatwearingUVblockingcontactlensesreducesthe
riskof developingcataractsor othereye disorders.ConsultyourEyeCare
Professionalformore information.
INDICATIONS (USES)
AllACUVUE OASYS BrandContactLenses,ACUVUE OASYS
BrandContactLensesforASTIGMATISM andACUVUE OASYS BrandContactLenses
forPRESBYOPIAcontaina UVBlocker tohelp protectagainsttransmissionof
harmfulUV radiationtothecorneaandintotheeye.
TheACUVUE OASYS BrandContactLens isindicated forthe
opticalcorrectionofrefractiveametropia(myopiaand hyperopia)inphakic
oraphakic personswithnon-diseasedeyeswho have1.00D orless
ofastigmatism.
TheACUVUE OASYS BrandContactLens forPRESBYOPIA
isindicatedfortheopticalcorrectionof distanceand nearvisionin
presbyopic,phakicoraphakicpersonswith non-diseasedeyeswho mayhave
0.75Dor lessof astigmatism.
TheACUVUE OASYS BrandContactLens forASTIGMATISM
isindicatedfortheopticalcorrectionof visualacuityin phakicor
aphakicpersonswith non-diseased
eyesthatarehyperopicormyopicandmayhave10.00Dorlessofastigmatism.EyeCare
Professionalsmayprescribethe lenseseitherfor
single-usedisposablewearor frequent/plannedreplacementwear
withcleaning,disinfectionand sched-uledreplacement(seeWearing
Schedule).Whenprescribedforfrequent/plannedreplacementwear,thelenses
maybe cleanedanddisinfected usinga
chemicaldisinfectionsystemonly.
ACUVUE OASYS BrandContactLenses,ACUVUE OASYS
BrandContactLensesforASTIGMATISM andACUVUE OASYS BrandContactLenses
forPRESBYOPIA
During Therapeutic use an adverse effect may be due to the
original disease orinjury or may be due to the effects of wearing a
contac t lens.There is a possi-bility that the existing disease or
condition might become worse when a softcontact lens for
therapeutic use is used to treat an already diseased injuredeye.
The patient should be instructed to avoid serious eye damage by
contact-ing the Eye Care Professional IMMEDIATELY if there is an
increase in symptomswhile wearing the lens.
FITTING GUIDELINES
I. GENERAL FITTINGI NSTRUCTIONSACUVUE OASYS
BrandContactLensesACUVUE OASYS BrandContactLenses
forASTIGMATISMACUVUE OASYS BrandContactLenses forPRESBYOPIA
A.PatientSelection:Patientsselectedto wearACUVUE OASYS
BrandContactLenses,theACUVUE OASYS BrandContactLenses
forASTIGMATISM andtheACUVUE OASYS BrandContactLenses forPRESBYOPIA
shouldbechosenbasedon:
Motivationtowearlenses
Abilitytofollowinstructionsregardinglenswearcare Generalhealth
Abilitytoadequatelyhandleandcareforthelenses
Abilitytounderstandtheriskandbenefitsoflenswear
Patientswhodonotmeettheabovecriteriashouldnotbeprovidedwithcontactlenses.
B. Pre-fitting
ExaminationInitialevaluationofthepatientshouldbeginwithathoroughcasehistorytodetermineif
thereare anycontraindicationsto contactlenswear. Duringthecase
history,the patientsvisualneedsand expectationsshould
bedeterminedaswell asan assessmentof theiroverall
ocular,physical,andmentalhealth.
Precedingtheinitial selectionoft rialcontact lenses,a
comprehensiveocularevaluationshouldbeperformedthatincludes,butis
notlimitedto,themeasurementofdistance andnear
visualacuity,distanceand
nearrefractiveprescription(includingdeterminingthe
preferredreadingdistancefor
pres-byopes),keratometryandbiomicroscopicevaluation.
Basedonthisevaluation,ifit
isdeterminedthatthepatientiseligibletoweartheACUVUE OASYS
BrandContactLenses,the ACUVUE OASYS
BrandContactLensesforASTIGMATISMortheACUVUE OASYS
BrandContactLensesfor PRESBYOPIA,theEye
CareProfessionalshouldproceed totheappropriatelensfitting
instructionoutlinedbelow.
ACUVUE OASYS BrandContactLenseswithHYDRACLEAR PLUS(senofilconA);
ACUVUE OASYS BrandContactLensesforASTIGMATISMwithHYDRACLEAR
PLUS(senofilconA);ACUVUE OASYS
BrandContactLensesforPRESBYOPIAwithHYDRACLEAR
PLUS(senofilconA)VisibilityTintedwithUV BlockerforDailyand
ExtendedWear.
SYMBOLS KEY
Thefollowingsymbolsmayappearon thelabelorcarton:
SphericalLenses For:Myopia,Hyperopia, PhakicorAphakic
MultifocalLensesFor:
Presbyopia,Phakic orAphakic
ToricLensesFor:MyopicAstigmatism,HyperopicAstigmatism,
MixedAstigmatism, Phakicor Aphakic
Lensesfor TherapeuticUse asa Bandage Lens
CAUTION: Federal U.S.A.lawrestrictsthisdeviceto salebyoron
theorderofa licensedpractitioner.
radiation.Thetransmittancecharacteristicsare lessthan1% inthe
UVBrange of280nmto315nm andlessthan10%in theUVArangeof316 nmto380nm
fortheentirepowerrange.
LensProperties:Specific Gravity(calculated): 0.98 1.12
RefractiveIndex: 1.42Light Transmittance: 85%minimum Surface
Character: HydrophilicWater Content: 38%Oxygen Permeability:
VALUE METHOD103x10-11 (cm2/sec) Fatt(boundarycorrected, edge
corrected)(ml O2/ml xmm Hg)at 35C122 x10-11 (cm2/sec)
Fatt(boundarycorrected,non-edgecorrected)(ml O2/ml xmm Hg)at
35C
LensParameters:TheACUVUE OASYS BrandContactLenses withHYDRACLEAR
PLUS (senofilcon
A),ACUVUE OASYS BrandContactLenses forASTIGMATISM
withHYDRACLEAR
PLUS (senofilconA)and theACUVUE OASYS BrandContactLenses
forPRESBY-OPIA withHYDRACLEAR PLUS (senofilconA) area
hemisphericaland/or hemitoricshellavailablewithin thefollowing
dimensions:
Diameter Range: 12.0mm to15.0mmCenterThickness: Lowminuslens
varieswithpower
Pluslens varieswithpowerBaseCurveRange: 7.85mm
to10.00mmPowerRange: SphericalPowers:DailyWear -20.00D
to+20.00D
ExtendedWearPowers: -20.00D to+14.00DMultifocalADD Powers:+0.25D
to+4.00DCylinderPowers: -0.25D to-10.00D
Axis:2.5 to180
AVAILABLE LENS PARAMETERS
ACUVUE OASYS BrandContact LensesDiameter: 14.0mmCenterThickness:
Lowminuslens varieswithpower(e.g.,4.00D:0.070mm)
Pluslens varieswithpower(e.g.,+4.00D:0.168mm)Base Curve: 8.4mm,
8.8mm PowerRange: -12.00Dto +8.00D
ACUVUE OASYS BrandContactLensesforASTIGMATISMDiameter:
14.5mmCenterThickness: Lowminuslens
varieswithpower(e.g.,4.00D:0.080mm)
Pluslens varieswithpower(e.g.,+4.00D:0.172mm)Base Curve:
8.6mm
DESCRIPTION
TheACUVUE OASYS BrandContactLenseswith HYDRACLEAR PLUS
(senofilconA),theACUVUE OASYS BrandContactLenses
forASTIGMATISMwithHYDRACLEAR
PLUS (senofilconA)andthe ACUVUE
OASYS
BrandContactLenses forPRESBY-OPIA withHYDRACLEAR PLUS
(senofilconA)Soft(hydrophilic)ContactLenses areavailableasa
Spherical,ToricorMultifocallens. Thelensesare madeof
asiliconehydrogelmaterialcontaininganinternalwetting
agentwithvisibility tintedUV absorb-ingmonomer.TheACUVUE OASYS
BrandContactLenseswith HYDRACLEAR PLUS(senofilconA),theACUVUE OASYS
BrandContactLenses forASTIGMATISM withHYDRACLEAR PLUS
(senofilconA)andthe ACUVUE OASYS BrandContactLensesforPRESBYOPIA
withHYDRACLEAR PLUS (senofilconA)
ContactLensVisibilityTintedwithUVBlockeraretintedblueusingReactiveBlueDye#4tomakethelensesmorevisiblefor
handling.AbenzotriazoleUV-absorbingmonomerisused toblock UV
PowerRange: Sphere:plano to6.00D (in0.25D increments)-6.50D
to9.00D (in0.50D increments)+0.25D to+6.00D (in0.25D
increments)Cylinder:-0.75D, -1.25D,-1.75D, -2.25D
Axis:10 to18 0(in 10 increments)ACUVUE OASYS Brand ContactLenses
for PRESBYOPIA withHYDRACLEAR PLUSDiameter: 14.3mmCenterThickness:
Lowminuslensvarieswithpower(e.g.,4.00D:0.070mm)
Pluslens varieswithpower(e.g.,+4.00D:0.170mm)Base Curve:
8.4mmPowerRange: -9.00Dto +6.00D
TRANSMITTANCE CURVES
ACUVUE OASYS BrandContactLenses withHYDRACLEAR PLUS
(senofilconA),ACUVUE OASYS BrandContactLenses forASTIGMATISM
withHYDRACLEAR
PLUS (senofilconA)and theACUVUE OASYS BrandContactLenses
forPRESBYOPIAwithHYDRACLEAR PLUS (senofilconA)Contact
LensVisibilityTintedwithUVBlockervs.24yr.oldhumancorneaand25yr.oldhumancrystallinelens.
*Thedatawas obtainedfrommeasurementstaken through thecentral
3-5mmportion forthethinnestmarketed lens(-1.00Dlens,
0.070mmcenterthickness).1. Lerman,S., RadiantEnergy and theEye,
MacMillan, New York, 1980, p.58, figure2-21
2. Waxler, M. Hitchins,V.M., Optical Radiation and Visual
Health, CRC Press, Boca Raton, Florida,1986, p.19,figure 5
WARNING:UV absorbing contactlenses are NOT substitutes for
protec-tive UV absorbing eyewearsuch asUV absorbinggoggles
orsunglassesbecause theydo notcompletely coverthe eye and
surrounding area.You should continue to use UV absorbing eyewear
asdirected.
25YR OLD HUMANCRYSTALLINELENS2
24YR OLD HUMANCORNEA1
VISTAKON
(senofilconA)ContactLensvisibilitytintwith UVBlocker*
LensOrientationCorrectLensInsideOut
Symbol
CAUTION: Federallaw restrictsthisdevicetosaleby oron
theorderofalicensed practitioner
CenterThickness
Cylinder Power
Axis
Cyl
Axis
LownearADD
MediumnearADD
HighnearADD
LOW
MID
HGH
Manufactured byorin
Consult Instructionsfor Use
