陨灶贼允韵责澡贼澡葬造皂燥造熏灾燥造援 7熏晕燥援 5熏 Oct.18, 圆园14 www.IJO.cn 栽藻造押8629原愿圆圆源缘员苑圆 8629-82210956 耘皂葬蚤造押ijopress岳员远猿援糟燥皂 窑ClinicalResearch窑 Safetyofprophylacticintracameralmoxifloxacin ophthalmicsolutionaftercataractsurgeryinpatients withpenetratingkeratoplasty

1DepartmentofOphthalmology,CerrahpasaMedicalFaculty, DOI:10.3980/j.issn.2222-3959.2014.05.10 IstanbulUniversity,Istanbul34098,Turkey 2DepartmentofOphthalmology,MedicalFaculty,Akdeniz ArslanOS,AriciC,UnalM,CicikE,ManganMS,AtalayE.Safetyof University,Antalya07070,Turkey prophylacticintracameralmoxifloxacinophthalmicsolutionafter Correspondence to: CeyhunArici.Departmentof cataractsurgeryinpatientswithpenetratingkeratoplasty. Ophthalmology,CerrahpasaMedicalFaculty,Istanbul 2014;7(5):795-799 University,Istanbul34098,[email protected] Received:2013-09-07Accepted:2013-11-25 INTRODUCTION ataractsurgeryisoneofthemostcommonsurgical Abstract C proceduresperformedintheworld.Althoughthe complicationsof this surgeryarerelativelyrare, · AIM: To determine the safety of prophylactic endophthalmitisisaseriousandpotentiallyvision-threatening intracameral moxifloxacin after surgery in complication,withonly35%ofpatientsachievingvisual patientswithpenetratingkeratoplasty(PKP). acuitybetterthan 20/200[1]. 逸 ·METHODS:Inthisretrospectivestudyofconsecutive Severalapproacheshavebeenadvocatedtodecreasetherate patientswhohadphacoemulsificationcataractsurgery ofpostoperativeendophthalmitis.Preoperativepovidone- afterPKP,weretreatedwithintracameralmoxifloxacin iodine antisepsiscombinedwithpreoperativeand 0.5%ophthalmicsolution (0.5mg/0.1mL).Themain postoperativetopicalantibiotictherapyisconsideredthe outcomemeasureswereanteriorchamberreaction,best standardofcare[2-4].Increasingattentionisdrawntothevalue correctedvisualacuity (BCVA),cornealendothelialcell ofanintracameralinjectionofantibioticattheendofcataract count(ECC),andcentralcornealthickness(CCT). surgerytoprovideimmediate,highantibioticlevelsthatare RESULTS:Fifty-fivepatientswererecruited(26males, · sustainedforaperiodoftime.Amongtheantibioticsgiven 29females).Themeanagewas54.36依4.97y(range45-64y). intracamerally,cefuroxime,vancomycinandmoxifloxacin AlleyeshadimprovedpostoperativeBCVA.Themean arethemostcommonlyused[5,6]. BCVAwas0.25preoperativelyand0.57postoperatively, Moxifloxacinisafourth-generationfluoroquinolone whichwasstatisticallysignificant ( <0.001).Oneeye antibacterialagentthatisactiveagainstmanygram-positive, had3+,7eyeshad2+,12eyeshad1+and8eyeshad traceamountofaqueouscellsonthefirstdayafter gram-negative,atypical,andanaerobicocularpathogens. surgery.Alleyeshadnoanteriorchambercellsat Consideringthepossiblecomplicationswithvancomycinand subsequent follow up examinations. Effective cefuroxime,moxifloxacinseemstobethebetterchoiceof phacoemulsificationtimewas4.33依1.01s.ThemeanECC antibioticforendophthalmitisprophylaxisbecauseofits was2340.20cells/mm2 preoperativelyand1948.75cells/ broad-spectrumcoverageandmodeofaction[7,8]. mm2 1mopostoperatively ( <0.001).Theincreaseof Toourknowledge,thisisthefirstreportofatopical 21.09 滋minpostoperativepachymetry1moaftersurgery ophthalmicpreparationappliedasaprophylacticagent wasstatisticallysignificant( <0.001). intracamerallyafter cataractsurgeryinpatientswith ·CONCLUSION:Nountowardeffectswereobservedafter penetratingkeratoplasty(PKP).Ourstudyevaluatedthe intracameralinjectionofmoxifloxacin(0.5mg/0.1mL)in safetyofinjectingprophylacticintracameralmoxifloxacinin termsofanteriorchamberreaction,CCT,ECC,andvisual humaneyeshavingcataractsurgeryinpatientswithPKP. rehabilitationattheconclusionofcataractsurgeryin SUBJECTSANDMETHODS patientswithPKP. Thisretrospectivestudyincludedeyesofconsecutivepatients · KEYWORDS: cataractsurgery;intracameralinjection; whohadphacoemulsificationcataractsurgeryafterPKPfor moxifloxacin;penetratingkeratoplasty;phacoemulsification cornealpathologyattheDepartmentofOphthalmology, 795 Intracameralmoxifloxacinincataractsurgery IstanbulUniversityCerrahpasaMedicalFaculty,between syringe,avolumeslightlyinexcessof0.1mL(0.3-0.4mL) May2008andFebruary2012.Allpatientshadafollow-upof ofthepuremoxifloxacin0.5%ophthalmicsolution.No 1moandsignedaninformedconsentdocument.Thestudy solution,includingsaline,wasaddedtodilutethecommercial wasin accordancewiththetenetsoftheHelsinki preparation.Theexcessamountwasdiscarded,leaving Declaration. 0.5mg/0.1mLofthenonpreservedmoxifloxacininthe SelectionCriteria PatientswithpreviousPKPdueto tuberculinsyringereadyforinjectionintotheanterior cornealpathology(herpesstromalscar(=19),stromal chamber.Thesolutionpreparedinthesyringewasinjected dystrophy( =17),keratokonus( =10),fuchsdystrophy( = usinga27-gaugecannulathroughthesideportintothe 9)requiringcataractsurgerywereincluded.Gradeofnuclear capsularbagafterhydrationofthesideportsandwater sclerosiswasN2andN3.Cataractsurgerywasperformedat tightnessof cornealincisionscontrolled. Moxifloxacin least3moafterPKPinallpatients.Patientswereover18yof ophthalmicsolution(Vigamox0.5%;AlconLaboratoriesInc., age.Patientswithglaucoma,,mediaopacitiesother FortWorth,Texas)suppliedasasterileisotonicsolution, thancataract(corneaorvitreous)andvisualpathway withpHat6.8andosmolalityof290mOsm/kg,makingit problemsandpatientstakingprostaglandinanalogueagents, compatiblewiththehumansanteriorchamberfluid(pH7.4; systemicimmunosuppressantsoranticoagulantsandcataract osmolality305mOsm/kg). surgerycaseswithintraperativecomplicationsincluding PostoperativetopicalVigamox0.5%wasinstilledevery2h posteriorcapsulerupture,vitreouslossand/orprolonged surgerytimewereexcludedfromthestudy.Anypatientswho whileawakeonthedayofthesurgeryandthentaperedto6 hadaprioreyeoperationexceptkeratoplastywerealso timesadayfor1wkand4timesadayforsubsequent2wk. excluded. Topicalprednisoloneacetate1%(PredForte)wasalsogiven SurgicalTechnique Allsurgeries(penetratingkeratoplasty postoperativelyusingthesamedosagescheduleusedfor andcataract)wereperformedbythesamesurgeon(O.S.A.). Vigamox. Penetratingkeratoplastysurgerieswereperformedunder Examinations Thepatientswerescheduledforfollow-up localorgeneralanesthesia.Allrecipientanddonorcorneas 1d,1wk,1moaftersurgery.Allpatientshadacompleteeye weretrephinedwithhand-heldtrephines.Graftdiameter examinationincludingbestcorrectedvisualacuity(BCVA) rangedfrom7.5-7.75mm,andthehostdiameterwas0.25mm (LogMarasadecimal),slitlampexamination,anterior smaller,exceptincasesofkeratoconus(samesize).Donor chamberreaction(cells)andcentralcornealthickness(CCT) corneawassuturedwith12-16interruptedandasingle measurementwithultrasoundpachymetryonthedayof continuoussuturesusing10-0nylon. surgeryandatpostoperativefollow-up.Specularmicroscopy Cataractsurgerywasperformedundertopicalanesthesia. wasperformedusingaNonconRobo(KonanMedical) Pupilsweredilatedwith1%cyclopentolate,1%tropicamide noncontactspecular microscope.Theimageofthe and2.5%phenylephrinedrops.Allsurgerieswereperformed endotheliumwasobtainedonanincorporatedscreen.Aftera usingtopical anesthesiaofproparacaine (Alcaine). clearimageofthecentralendotheliumwascaptured,the Uneventful phacoemulsificationwasperformedin a centersofatleast100contiguousendothelialcellswere standardizedfashionthrougha2.75mmclearcorneal marked.Theendothelialcellcount (ECC)andothercell incision.Sodiumhyaluronate3.0%-chondroitinsulfate4.0% parameterswerethendisplayedonthecomputerscreen.The (Viscoat)andsodiumhyaluronate1.0%(Provisc)wereused microscopywasrepeated3timesforeachmeasurement,and forendothelialprotection,anteriorchamberstabilizationfor themeanvaluewasusedforanalysis.Specularmicroscopy continuouscurvilinearcapsulorhexisandintraocularlens ofthedonorcornealendotheliumandCCTwasperformed (IOL) implantationrespectively.AcrySofIQ SA60AT preoperativelyandrepeatedpostoperativelyat1mo. intraocularlenses (AlconLaboratoriesInc.,FortWorth, Anteriorchambercellsweremeasuredusinga2mmlong Texas)wereimplanted. and1mmwideslitbeamwithmaximallightintensityand Allpatientsunderwentperiorbitalantisepsiswithgauze soakedpovidone-iodine10%applicationontheclosedlids, magnificationbeforemydriasisandscoredasfollows: ,browandtheadjacentforehead,nose,cheeks,and trace=1to5cells;+1=6to15cells;+2=16to25cells;+3=26 temporalorbitalareafor3min.Theconjunctivalsacwas to50cells;+4=morethan50cells. vigorouslyirrigatedwith5mLofpovidoneiodine5% StatisticalAnalysis Dataanalysiswasperformedusing solutionjustpriortosurgeryafter3min,conjunctivalsacwas SPSSsoftware(version15.0,SPSS,Inc.).Preoperativeand irrigatedwith30mLbalancedsaltsolution. postoperativecomparisonsofCCTandECCwereperformed Towardstheendoftheoperation,thecontentsofanewly withthepairedsamplestest.BCVAwasstudiedwith openedbottleofmoxifloxacinophthalmicsolution0.5% Wilcoxonsigned-ranktest.A valuelessthan0.05was (Vigamox)wasaspiratedbyanurseintoasteriletuberculin consideredstatisticallysignificant. 796 陨灶贼允韵责澡贼澡葬造皂燥造熏灾燥造援 7熏晕燥援 5熏 Oct.18, 圆园14 www.IJO.cn 栽藻造押8629原愿圆圆源缘员苑圆 8629-82210956 耘皂葬蚤造押ijopress岳员远猿援糟燥皂 RESULTS Fifty-fiveeyesof55patients(26males,29females)were includedinthestudy.Themeanagewas54.36 4.97y(range 依 45-64y).AlleyeshadimprovedpostoperativeBCVA.The meanBCVAwas0.25 0.11preoperativelyand0.57 0.24 依 依 postoperatively,whichwasstatisticallysignificant( <0.001) (Figure1).Nopostoperativeepithelialdefectswasobserved. Noeyehadcornealedemaonthefirstdaypostoperatively, exceptfor3eyes,whichhadmildcornealstromaledema.No eyehad cornealedemaatsubsequent follow-up examinations.Onedayaftercataractsurgery,1eyehad3+,7 Figure1Meanpreoperativeand1mopostoperativebest eyeshad2+,12eyeshad1+and8eyeshadtraceamountof correctedvisualacuity(BCVA). aqueouscells.Alleyeshadnoanteriorchambercellsat subsequentfollowupexaminations. Effective phacoemulsificationtime(EPT)was4.33 1.01s(range 依 2.5-5.9s). ThemeanECCwas2340.20 187.21cells/mm2 preoperatively 依 and1948.75 246.76cells/mm2 1mopostoperatively.The 依 ECCwasstatisticallysignificantlylowerthanpreoperatively ( <0.001).ThemeanCCTwas560.96 13.22 mpreoperatively 依 滋 and582.05 17.21 m1mopostoperatively;thedifference 依 滋 wasstatisticallysignificant( <0.001)(Figure2). DISCUSSION Age-relatedcataractisoneoftheleadingcausesofvisual Figure2Meanpreoperativeand1mopostoperativeendothelial impairmentworldwideandcataractextractionisoneofthe cellcount (ECC) (cells/mm2)andcentralcornealthickness mostfrequentlyperformedsurgicalproceduresintheworld. (CCT)(滋m). Endophthalmitisisanuncommonbutseriousintraocular infectionthatoccursmostcommonlyasacomplicationof to1.9 g/mLintheaqueoushumor [13].Preoperativedosing 滋 intraocularsurgeryandoftencausesseverevisualimpairment scheduleswithmorefrequentdropinstillation,rangingfrom oreventhelossofaneye[9]. 1dropevery10minforonehourbeforesurgeryandevery2h Inspiteofimprovementsinmicrosurgicalandaseptic for3dbeforesurgeryproducedaqueoushumorlevels techniques,astudyofMedicarepatientswhounderwent 1.58 g/mLand2.3 g/mLrespectively[14,15]. 滋 滋 cataractextractionfrom1994to2001reportedaanincreased Inourstudy,the500 gdoseofmoxifloxacinusedis 滋 rateofpostoperativeendophthalmitisinthestudyperiod[10].A expectedtoproduceanaqueoushumorconcentrationof systematicreviewalsoreportedevidenceofanincreasing approximately500 g/0.525mL(theapproximatefluid 滋 rate [11].Severalstudiessuggestthattherouteofantibiotic capacityofthecombinedanteriorandposteriorchambers administrationmaybeamongthemostimportantfactorsin aftercrystallinelensextractionwithanIOLimplantedinthe preventingpostoperativeendophthalmitis[3,5,6]. capsularbagis0.525mL)orcomparativeconcentrationsof Antibioticpenetrationintotheanteriorchamberaftertopical 952 g/mL[16]. 滋 dropsisrelativelylowcomparedwithintracameraldoses, Thesepeakaqueoushumorlevelsintheanteriorchamber restrictedbyanintactcornealepitheliumanddilutionand afterinjectionwasapproximatelymorethan3000-foldabove [12] removalbytears .Directintracameralinjectionofantibiotic thetestedMIC50 (minimuminhibitoryconcentration)of hasseveraladvantagesovertopicaldropregimens.Thisroute moxifloxacinagainstcommonocularpathogenssuchas ofinjectiondeliversveryhighconcentrationsofanantibiotic Staphylococcus aureus(0.03 g/mL),staphylococcus 滋 agenttotheanteriorchamberatthecloseofsurgerywiththe epidermidis(0.06 g/mL),propionibacteriumacnes 滋 presumedeffectoferadicatingbacteriabeforewoundclosure (0.25 g/mL),andbacilluscereus(0.13 g/mL)[8]. 滋 滋 andintheimmediatepostoperativeperiod.Commonlyused Moxifloxacinisafourth-generationfluoroquinolone dosageschedulessuchas1drop4timesdaily,evenwithan antibioticagent.Comparedwithearliergenerationsof additionaldrop,producedtherapeuticmoxifloxacinlevelsup fluoroquinolones suchasciprofloxacin,ofloxacin,and 797 Intracameralmoxifloxacinincataractsurgery levofloxacin,moxifloxacinoffersbroaderspectrumandmore showedthatVigamoxcausesnoinflammationintheanterior potentactivityagainstgram-positivebacteria.itisalso chamberandvitreus. rapidlybactericidalagainstmanyocularisolatesresistantto Espiritu [16] andLane [19] injectedanintracameral olderfluoroquinolones [8,17].Moxifloxaciniscommercially doseof0.5mg/0.1mLand0.25mg/0.05mLofthecommercially availableasaself-preservedophthalmicformulation, availableundilutedmoxifloxacin0.5%ophthalmicsolutions, containingnobenzalkoniumchloride (BAK)orother respectively,whereasArbisser[6] usedthemoxifloxacin0.5% preservativesknowntohavetoxiceffectsonoculartissues[18]. dropsolutiondilutedwithbalancedsaltsolutiontoa Asaselfpreservedsolution,Vigamoxophthalmicsolution 0.1mg/0.1mLdoseforintracameralinjection.Allofthese requiresnospecialpreparationforintracameralinjection, studiesshowednoincreasedsafetyriskassociatedwith reducingtheriskfortoxicanteriorsegmentsyndrome prepareddosesofintracameralinjectionofmoxifloxacin, (TASS).Inaddition,somestudiesofhumanbeingsdidnot which appearstobesafeinthe prophylaxisof showintraoculartoxicityafterinjectionofintracameral endophthalmitisaftercataractsurgery.Inthepresentstudy, moxifloxacin [16,19,20].Vancomycinandcefuroximeisavailable weusedasolutionofVigamoxdrops,injectingadoseof inasystemicpreparationthatmustbereconstitutedusing 0.5mg/0.1mLaftercataractsurgeryinpatientswithPKP. salinesolutionbeforeitcansafelybedeliveredtotheeye. Theresultsinourstudysupporttothesafetyprofileofan Reconstitutingthedrugforintracameralusemayincreasethe intracameralinjectionofmoxifloxacinfortheprophylaxisof riskforTASSbecauseanundesiredconcentrationofthedrug . maybeinadvertentlyinjectedifamistakeoccursduringthe Inconclusion,thefindingsinourstudysupportthesafetyof preparationordilutionprocess[21]. anintracameralinjectionofVigamox(0.5mg/0.1mL)in Inourstudy,statisticallysignificantevidenceofreduced termsofanteriorchamberreaction,CCT,ECCandvisual endothelialcells,increasedcornealthicknessandincreased rehabilitation.ThisstudyestablishedthatVigamoxcansafely BCVA wasfound1mopostoperativelycomparedto begivenintracamerallyaftercataractsurgeryinpatientswith preoperatively. PKP.However,follow-upwasforonly1mo.Furtherstudies Weexcludedpatientsiftheyhadcomplicationsthatcouldbe toproveitseffectivenessinpreventingendophthalmitisand thepossiblecausesofendothelialcelllossafterkeratoplasty longerfollow-uparerequired. orcataractsurgeryincludinggraftrejection,, ACKNOWLEDGEMENTS uveitis,andcornealulceration. ConflictsofInterest:ArslanOS, None; AriciC, None; Inhealthyeyesthathavenotundergoneoperation, UnalM, None; CicikE, None; ManganMS, None; Atalay endothelialcelldensitydeclinesatabout0.6%peryear [22]. E, None. 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798 陨灶贼允韵责澡贼澡葬造皂燥造熏灾燥造援 7熏晕燥援 5熏 Oct.18, 圆园14 www.IJO.cn 栽藻造押8629原愿圆圆源缘员苑圆 8629-82210956 耘皂葬蚤造押ijopress岳员远猿援糟燥皂 7YoeruekE,SpitzerMS,SaygiliO,TatarO,BiedermannT,YoeruekE, 16EspirituCR,CaparasVL,BolinaoJG.Safetyofprophylactic Bartz-SchmidtKU,SzurmanP.Comparisonof safetyprofilesof intracameralmoxifloxacin0.5%ophthalmicsolutionincataractsurgery vancomycinandcefuroximeonhumancornealendothelialcellsfor patients. 2007;33(1):63-68 intracameraluse. 2008;34(12):2139-2145 17KowalskiRP,DhaliwalDK,KarenchakLM,RomanowskiEG,MahFS, 8StromanDW,DajcsJJ,CuppGA,SchlechBA. and RitterbandDC,GordonYJ.Gatifloxacinandmoxifloxacin:an potencyofmoxifloxacinandmoxifloxacinophthalmicsolution0.5%,anew susceptibilitycomparisontolevofloxacin,ciprofloxacin,andofloxacinusing topicalfluoroquinolone. 2005;50(Suppl1):S16-S31 bacterialkeratitisisolates. 2003;136(3):500-505 9DurandML.Endophthalmitis. 2013;19(3):227-234 18AyakiM,YaguchiS,IwasawaA,KoideR.Cytotoxicityofophthalmic 10WestES,BehrensA,McDonnellPJ,TielschJM,ScheinOD.The solutionswithandwithoutpreservativestohumancornealendothelialcells, incidenceofendophthalmitisaftercataractsurgeryamongtheU.S. epithelialcellsandconjunctivalepithelialcells. Medicarepopulationincreasedbetween1994and2001. 2008;36(6):553-559 2005;112(8):1388-1394 19LaneSS,OsherRH,MasketS,BelaniS.Evaluationofthesafetyof 11TabanM,BehrensA,NewcombRL,NobeMY,SaediG,SweetPM, prophylacticintracameralmoxifloxacinincataractsurgery. McDonnellPJ.Acuteendophthalmitisfollowingcataractsurgery:a 2008;34(9):1451-1459 systematicreviewoftheliterature. 2005;123(5):613-620 20KerntM,NeubauerAS,LieglRG,LackerbauerCA,EiblKH,AlgeCS, 12FukudaM,YamadaM,KinoshitaS,InatomiT,OhashiY,UnoT, UlbigMW,AAK.Intracameralmoxifloxacin: safetyonhuman ShimazakiJ,SatakeY,MaedaN,HoriY,NishidaK,KubotaA,Nakazawa ocularcells. 2009;28(5):553-561 T,ShimomuraY.Comparisonofcornealandaqueoushumorpenetrationof 21MamalisN,EdelhauserHF,DawsonDG,ChewJ,LeBoyerRM,Werner moxifloxacin,gatifloxacinandlevofloxacinduringkeratoplasty. L.Toxicanteriorsegmentsyndrome. 2006;32(2): 2012;29(4):339-349 324-333 13McCulleyJP,CaudleD,AronowiczJD,ShineWE.Fourth-generation 22YunliangS,YuqiangH,Ying-PengL,Ming-ZhiZ,LamDS,RaoSK. fluoroquinolonepenetrationintotheaqueoushumorinhumans. CornealendothelialcelldensityandmorphologyinhealthyChineseeyes. 2006;113(6):955-959 2007;26(2):130-132 14LaiWW,ChuKO,ChanKP,ChoyKW,WangCC,TsangCW,PangCP. Differentialaqueousandvitreousconcentrationsofmoxifloxacinand 23BourneWM,NelsonLR,HodgeDO.Continuedendothelialcelllossten ofloxacinaftertopicaladministrationonehourbeforevitrectomy. yearsafterlensimplantation. 1994;101(6):1014-1023 2007;144(2):315-318 24ShimmuraS,OhashiY,ShiromaH,ShimazakiJ,TsubotaK.Corneal 15HariprasadSM,BlinderKJ,ShahGK,ApteRS,RosenblattB, opacityandcataract:tripleprocedureversussecondaryapproach. HolekampNM,ThomasMA,MielerWF,ChiJ,PrinceRA.Penetration 2003;22(3):234-238 pharmacokineticsoftopicallyadministered0.5%moxifloxacinophthalmic 25KimEC,KimMS.Acomparisonofendothelialcelllossafter solutioninhumanaqueousandvitreous. 2005;123(1): phacoemulsificationinpenetratingkeratoplastypatientsandnormal 39-44 patients. 2010;29(5):510-515

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