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陨灶贼允韵责澡贼澡葬造皂燥造熏灾燥造援 9熏晕燥援 5熏May18, 圆园16 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
TherefractiveoutcomeofToricLentisMplusimplantin
cataractsurgery
窑ClinicalResearch窑
1BirminghamandMidlandEyeCentre,CityHospital,
BirminghamBH187QH,UnitedKingdom
2OptegraManchesterEyeHospital,ManchesterM202EY,
UnitedKingdom
Correspondenceto: PatrickJChiam.Birminghamand
MidlandEyeCentre,CityHospital,DudleyRoad,Birmingham
BH187QH,UnitedKingdom.pjtchiam@yahoo.com
Received:2015-09-20Accepted:2015-11-17
Abstract
·AIM:ToevaluatetherefractiveoutcomeofToricLentis
Mplusintraocularlens(IOL)implant.
·METHODS: This is a retrospective case series.
Consecutivepatientswithcornealastigmatismofatleast
1.5DhadToricLentisMplusIOLimplantduringcataract
surgery. The exclusion criteria included irregular
astigmatismoncornealtopography,largescotopicpupil
diameter (>6mm),poorvisualpotentialandsignificant
ocularcomorbidity.Postoperativemanifestrefraction,
uncorrected distance visual acuity (UDVA), best-
correcteddistancevisualacuity (BCVA),uncorrected
intermediate visual acuity at (UIVA) 3/4 m and
uncorrectednearvisualacuity(UNVA)wereobtained.
·RESULTS:Therewere70eyesfrom49patientsinthis
study.Patientswererefractedatamedianof8.9wk
(range4.0to15.5)fromtheoperationdate.Sixty-five
percentofeyeshad6/7.5 (0.10logMAR)orbetter,and
99%6/12 (0.30logMAR)orbetterpostoperativeUDVA.
Eighty-ninepercentcouldreadJaeger(J)3(0.28logMAR)
and95%J5 (0.37logMAR)at40cm.Themedian
magnitudeofastigmatismdecreasedfrom1.91Dto0.49D
(Wilcoxon, <0.001)aftertheoperation.Therangeofthe
cylindrical error was reduced from 1.5-3.95 D
(keratometric)preoperativelyto0.00-1.46D(subjective
refractiontransposedtocornealplane)postoperatively.
·CONCLUSION:ToricLentisMplusIOLhasgood
predictabilityinreducingpreexistingcornealastigmatism.
·KEYWORDS: ToricLentisMplus;multi-focalintraocular
lensimplant;refractiveoutcome
DOI:10.18240/ijo.2016.05.10
ChiamPJ,QuahSA.TherefractiveoutcomeofToricLentisMplus
implantincataractsurgery. 2016;9(5):699-702
INTRODUCTION
Multifocalintraocularlenses(IOLs)werefirstintroduced
inthe1980s [1-2].Meta-analysesofrandomisedcontrol
trialsshowedtheseIOLsimproveuncorrectednearvisual
acuitywithoutcompromisingdistancevisualacuityand
reducespectacledependence [3-5].However,thepresenceof
morethan1diopter(D)astigmatismhasbeenshowntohave
anadverseeffectontheperformanceoftheseIOLs[6-8].Thisis
asignificantissueespeciallycornealastigmatismof1.25D
ormoreisprevalentinupto30%ofeyesthathavecataract
surgery [9-12].ToricIOLhasbeenreportedtoprovidebetter
predictabilityinreducingmoderatecornealastigmatism
comparedtooppositeclearcornealincisionorarcuate
keratotomy[13-14].
Today'spatientsaremoredemanding,andtheyseektotal
visualrehabilitationandspectacleindependence.These
requirements havespurredthedevelopmentoftoric
multifocalIOLs.TheseIOLssimultaneouslycorrectcorneal
astigmatismandthelossofaccommodativeabilityafter
crystallinelensextraction.Theimplantationoftoricmonofocal
IOLsduringphacoemulsificationhasbeenshowntobe
effectiveincorrectingpreexistingcornealastigmatism[15-17].
TheLentisMplusisrefractiverotationalasymmetryIOL
designedtoovercomethedrawbacksofmultifocalIOLsby
providinghighcontrastsensitivityandminimizinghalosand
glare [16].TheLentisMplusIOLconsistsof2radialsectors-
onefordistanceandtheotherfornearvision.Currentlythere
arethreestrengthsofaddition(add)fornear 依3.00D(LS-312
MF30),+2.00D(LS-312MF20)and+1.50D(LS-312MF15).
Eighty-fourpercentofpatientswithbilateralLentisMplus
+3.00Daddimplantshavebeenshowntobespectacle
independentfordistant,intermediateandnearvision [16].A
toricversionofthisIOL(LU-313MF30T)isavailable
howeverthereisnodatapublishedtodate.Thepurposeof
thisstudyistoevaluatetherefractiveoutcomeoftheToric
LentisMplusIOL.
SUBJECTSANDMETHODS
Subjects Thisisaretrospectivecaseserieswith70
consecutiveeyesimplantedwithToricLentisMplusIOL
duringphacoemulsification.Thepatientswereoperated
betweenJanuary2011andDecember2012byasingle
surgeon(QuahSA)atOptegraManchesterEyeHospital,UK.
ThetenetsoftheDeclarationofHelsinkiwerefollowedfor
allstudyprocedures.Becausethisisaretrospectivestudy
informedconsentwasnotobtainedfromthesubjects.
TheinclusioncriteriaforthetoricIOLimplantwereregular
cornealastigmatismofatleast1.5D.Theexclusioncriteria
includedirregularastigmatismoncornealtopography,large
scotopicpupildiameter(>6mm),poorvisualpotentialand
significantocularcomorbidity maculardiseaseand
glaucoma.
IntraocularLens ToricLentisMplus(modelLU-313
MF30T)isabiconvex1-piecemultifocalacrylicIOLmade
699
withanasphericposteriorsurfacedesign.TheIOLhasan
11.0mmoveralllength,a6.0mmoptic,andasquarehaptic
design with 0-degreeangulation.Thenon-rotational
symmetricmultifocalIOLwitharefractivedesigncombines
anasphericasymmetricdistancevisionzonewithasector-
shapednearvisionzonewitha+3.00Dadd.AllToricLentis
Mpluslensesarecustommadeandorderedusinganonline
toricintraocularlenscalculator(www.lentistoric.com).
SurgicalTechnique Alloperationswereperformedwithout
anycomplications.Marksweremadeonthecorneaunder
topicalanaestheticontheslit-lamppreoperatively.Anarrow
slitbeamwasdirectedatthecentreofthepupilacrossthe
corneahorizontally.Peri-limbalscratchesat30毅andthe
steepestaxisofalignmentweremadewithasterileneedle.A
surgicalmarkerpenwasthenusedtostainthesescratches.
Atthestartoftheoperation5.5mmdiameterwasmarkedon
thecorneatofacilitatethedesireddiameterofcapsulorrhexis.
Phacoemulsificationwasperformedthrougha2.75mmclear
cornealincisionplaced30毅temporallyinallcases.TheIOLs
wereimplantedusingadisposableinjector(viscojectBIO2.2
injector).ThereferencemarksontheopticofIOLwerethen
alignedwiththepremarkedsteepestaxisandthenearsector
oftheIOLopticplacedinferiorly.
Thetargetedsphericalequivalentwaszeroorthefirst
negative(myopic)figure.Postoperativepatientswereadvised
tousetopicalsteroidforamonthandantibioticfora
fortnight.Thefelloweyewasoperatedwithin1molater.
PatientExamination Preoperatively,allpatientsunderwent
acompleteophthalmicevaluationincludingsubjective
refraction,biometrywithIOLMaster500(CarlZeiss),
cornealtopographyandpupillometrywithSchwindSirius
andCombiWavefrontAnalyzer,slitlampexamination,
fundoscopyandapplanationtonometry.Uncorrecteddistance
visualacuity(UDVA),best-correcteddistancevisualacuity
(BCVA),uncorrectedintermediatevisualacuityat(UIVA)
3/4manduncorrectednearvisualacuity(UNVA)were
obtained.
DataandStatisticalAnalysis Thedatawerecollectedin
Microsoft誖OfficeExcel 誖2007spreadsheetandanalyzed
withIBM 誖SPSS 誖Statisticsversion20.Snellenacuities
wereconvertedintologMARforstatisticalcalculations.
Themagnitudeofrefractivechangeinducedbytheclear
cornealmainincisionatthebeginningofthesurgerywas
takenas0.50DandfactoredintothetoricIOLcalculation.
Thepostoperativeastigmatismisthemanifestrefractive
cylindricalerrorobtainedpostoperatively.Thelatterwas
vertexedonthecorneaplaneforcomparisonwith
preoperativekeratometricastigmatism.
Shapiro-Wilktestwasusedtoascertainthedatadistribution
fornormality.PairedStudent's -testandWilcoxonsigned
ranktestwereusedtoanalyseparametricandnon-parametric
data respectively.Thepost-operativeastigmatismwas
determinedwhetheritwasdifferentfromzerousingdioptric
powermatrixtransformation.Whereappropriatetheresults
werereportedasmean依standarddeviation.
Thedifferencevector(DV)isthevectorthatallowsthe
inducedsurgicalastigmatismeffecttointendedsurgical
astigmatismeffect.Thisisanabsolutemeasureofsuccess
andideallyshouldbezero.Themagnitudeoferror(ME)is
thearithmeticdifferencebetweenthemagnitudesofthe
inducedsurgicalastigmatismeffectandintendedsurgical
astigmatismeffect.TheMEispositiveifthereisan
overcorrectionandnegativeforundercorrection.Theangleof
error (AE)istheanglebetweentheinducedsurgical
astigmatismeffectandintendedsurgicalastigmatismeffect
vectors.IfAEispositive,thismeanstheachievedcorrection
iscounterclockwisetotheintendedaxis;ifnegativeitis
clockwisetotheintendedaxis.Theabsoluteangleoferror
(AAE)isthesumoftheabsolutedifferencebetweenthe
intendedandinducedangleofcorrection.Thecorrection
index(CI)wascalculatedastheratiooftheabsolutevalues
ofInducedsurgicalastigmatismeffecttotheIntended
surgicalastigmatismeffect.Anidealcorrectionindexis1.0.
Ifthisisgreaterthan1.0,itmeanstheoperationhascausedan
overcorrection,andiflessthan1.0referstoundercorrection.
RESULTS
Therewere70eyesfrom49patientsinthisstudy.There
were34female(47eyes)patients.Themeanagewas60.2依
7.7year-old(range47to81).Thirty-sevenrightand33left
eyeswereoperated.Therewerenointraoperative
complications.Seveneyeswithamblyopiaanddocumented
visualpotentialofatleast0.30logMARwereincluded.
ThesetofdatadistributedinaGaussianfashionwerepreand
postoperativesphericalequivalentonly(Shapiro-Wilk, =0.21
and =0.18).Therestwasnon-Gaussian.
VisualOutcome Patientswererefractedatamedianof
8.9wk(range4.0to15.5)fromtheoperationdate.Table1
showsthepreoperativeandpostoperativevariousdistance
visualacuities.Sixty-fivepercentofeyeshad6/7.5(0.10
logMAR)orbetter,and99%6/12(0.30logMAR)orbetter
postoperativeUDVA.Eighty-ninepercentcouldreadJaeger
(J)3(0.28logMAR)and95%J5(0.37logMAR)at40cm.
Fifty-sixeyes(80%)hadamanifestastigmaticerrorof0.75D
orless.Intheseeyes,themedianUDVAwas0.10logMAR
(range-0.10to0.30),UIVA0.05(range-0.10to0.20)and
UNVA0.13(range0.00to0.60).Theremainingfourteen
eyeshadastigmaticerrorofmorethan0.75D(maximumwas
1.5D).Inthisgroup,themedianUDVAwas0.23logMAR
(range0.10to0.50),UIVA0.10(range0.10to0.30)and
UNVA0.20(range0.10to0.53).TheWilcoxon valuesfor
eachdistantwas0.0001,0.003and0.008.
RefractiveOutcome Table2showsthepreoperativeand
postoperativerefractivechanges.Thesphericalequivalent
(SE)beforeandaftertheToricLentisMplusimplantwasnot
statisticallysignificant(pairedStudent's -test, =0.71).The
medianmagnitudeofastigmatismdecreasedfrom1.91Dto
0.49D(Wilcoxon, <0.001)aftertheoperation.Themean
sphericalequivalentpostoperativewas0.00 依0.36Dandthe
rangewas-1.00to+1.00D.
Table3revealsthevectorialanalysisoftheastigmatic
change.TheDVwasnotsignificantlydifferentfromzero( =
0.48).Therewasaslightovercorrection,asindicatedbyaCI
of1.07.
ToricLentisMplusrefractiveoutcome
700
陨灶贼允韵责澡贼澡葬造皂燥造熏灾燥造援 9熏晕燥援 5熏May18, 圆园16 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
Forty-eighteyes(69%)hadapostoperativesubjectiverefractive
cylinder(atspectacleplane)ofupto0.50D,and56eyes
(80%)upto0.75D.Twoeyesfromdifferentpatientshada
residualcylinderof1.25Dand1.50D.Theseweretheonly
oneshigherthan1.00D.Therangeofthecylindricalerror
wasreducedfrom1.5-3.95D(keratometric)preoperatively
to0.00-1.46D(subjectiverefractiontransposedtocorneal
plane)postoperatively.Figure1showstheindividualchange
in preoperative keratometric astigmatismcomparedto
postoperativesubjectiverefraction.Thedoubleanglevector
diagramshowedareducedrangeofastigmaticspreadafter
theIOLimplant(Figure2).
PatientSatisfaction AllpatientsweresatisfiedwiththeIOL
implantandwouldrecommendtheproceduretoafriend.
Theseincludedthetwopatientswithresidualpostoperative
astigmatismof1.25Dandmore.Theirpreoperative
astigmatismswere2and3Drespectively.Despitethe
photopicphenomenonwasnotformallyevaluated,nopatients
complainedofseveresymptomsrequiringexplantation.
DISCUSSION
OurresultsshowthatToricLentisMplusIOLhasgood
predictabilityinreducingtheamountofpreexistingcorneal
astigmatismwhichiscrucialinallowingthemaximum
multifocalutility.Preoperativelythemediankeratometric
astigmatismwas1.91D,andthiswasreducedtoamedianof
0.49Dinthepostoperativesubjectiverefractiveastigmatism.
Currently,thepublishedliteratureonthevisualoutcomeof
ToricLentisMplusislimited.Inourstudy,69%ofeyeshada
subjectivemanifestastigmatismof0.50Dorless;and80.0%
had0.75Dorlessaftertheoperation.Thisiscomparableto
theonlypublisheddataonToricLentisMplusbyVenterand
Pelouskova[18] where65%ofeyeshadarefractiveastigmatism
of0.50Dorlessdespitetheirrangeofpreoperative
astigmatismwasslightlywider.Themeanpreoperative
keratometricastigmatisminourstudywasonly2.2D,while
thestudyaforementionedwas3.0D.Inothertypesoftoric
multifocal IOLstudies withcomparable preoperative
astigmatism,themeanpostoperativerefractivecylinderswere
foundtobe0.40依0.25Dand0.71依0.42D
[19-20].Anotherseries
withhigherpreoperativeastigmatismof3.4依1.17Drevealed
a3-monthpostoperativeresultof0.80依0.42D
[21].
Vectoranalysisoftheoverallastigmaticchangeshowsthat
theToricLentisMplushasexcellentpredictabilityin
correctingastigmatismasshownbythesmallindicesofME,
AE,AAEandCI.Ourstudycouldnodemonstrateaclear
relationshipbetweentheamountofpreoperativeastigmatism
withtheresidualpostoperativeastigmatismasshownby
Figure1.Alargerstudyisrequiredforthis.
Table 1 Preoperative and postoperative visual acuity and refractive error
Visual Acuity Preoperative
(logMAR)
Postoperative
(logMAR) P
Median UDVA
0.90 0.10
Range -0.10 to 1.70 -0.1 to 0.5
Mean UDVA 0.76 0.10
<0.001a
Median BCVA
0.10 0.00
Range -0.10 to 0.60 -0.10 to 0.30
Mean BCVA 0.10 0.03
0.001a
Median UIVA 0.35 0.10
Range 0.00 to 0.40 -0.10 to 0.30
Mean UIVA 0.28 0.06
0.002a
Median UNVA
0.63 0.13
Range 0.10 to 0.90 0.00 to 0.60
Mean UNVA 0.55 0.18
<0.001a
aWilcoxon signed rank test.
Table 2 Preoperative and postoperative refractive changes
Refractive error Preoperative (D)
Postoperative (D) P
Spherical equivalent
Mean±SD -0.27±5.05 0.00±0.36 0.71a
Range -10.00 to +9.13
-1.00 to +1.00
Astigmatism (Keratometric) (Subjective refraction
at corneal plane)
Vector 1.41 at 89.5° 0.18 at 28.7°
Median magnitude
1.91 0.49 <0.001b
Range 1.5 to 3.95 0.00 to 1.46
aPaired student’s t-test; bWilcoxon signed rank test.
Figure2Double-anglevectorialdiagramforpositivecylinder
(D)preandpostoperation.
Figure1Changeinpreoperativekeratometricastigmatism
versuspostoperativesubjectiverefractiveastigmatism.
Table 3 Preoperative and postoperative astigmatism analysis
Parameters Astigmatism
Intended surgical astigmatism effect 1.41 D at 179.5°
Induced surgical astigmatism effect 1.51 D at 2.4°
Difference vector 0.18 D at 28.7°a
Magnitude of error (D) 0.10±0.36
Angle of error 2.8°±4.5°
Absolute angle of error 3.7°±5.2°
Correction index 1.07
aNot significantly different from zero; P=0.48 (dioptric power matrix
transformation).
sx
±
701
TheUDVAinourstudywas0.10logMARwhichwas
slightlyworsebutwithinoneSnellenlineofVenterand
Pelouskova's [18] resultof0.03.Oneofthereasonsmightbe
duetotheinclusionof7amblyopiceyesalbeittheirbest
recordedvisualpotentialwasatleast0.3logMARorbetter.
Excludingtheseeyes,ourUDVAimprovedto0.09logMAR.
OurfindingsonUNVAwas0.18logMARwhichwasalmost
thesameasVenterandPelouskova's [18] findingof0.17.Ina
largeseriesnon-ToricLentisMplusdata,themeanUDVA
was0.05logMARandUNVA0.21[22].
Patientsfoundwithresidualobjectiveastigmatismofmore
than0.75Daremorelikelytobedissatisfiedwiththeir
vision [23-24].Ourresultsshowedacuitiesatalldistanceswere
statisticallysignificantlyworsewhentheastigmatismwas
morethan0.75D.Thisshowstheimportanceofresidual
astigmatismtobecorrectedbelowthislevel.It'snotinthe
remitofthisstudytodiscusstheoptionsavailabletoenhance
therefractiveerrorinthesecases.
Themeanpostoperativesphericalequivalentinourstudywas
excellentat0.00依0.36D.Alargestudyofnon-ToricLentis
Mplus,withafollow-upofmorethan5000eyesat3-month
foundaSEof-0.02 依0.60Dwhichiscomparableour
findings [22].ThisshowsthepredictabilityofToricLentis
Mplusiscomparabletothenon-ToricLentisMplus.
OurstudyfoundtheToricLentisMplusLU-313MF30Thas
similarvisualacuitiesatdistanceandnearcomparedtothe
non-toricversionofthesameIOL.Eyeswithnooraresidual
astigmatismoflessthan0.75Dhasthebestacuityoutcome.
Therefractiveoutcomesconfirmthecorrectionofastigmatism
bythisIOLhasagoodpredictabilityinmajorityofcases.
ACKNOWLEDGEMENTS
ChiamPJanalysedandwrotethemanuscript,QuahSA
conceivedthestudyidea,collectedthedataandprovided
criticalreview.
ThestudywasperformedattheOptegraManchesterEye
Hospital,UnitedKingdom.
ConflictsofInterest:ChiamPJ, None; QuahSA, None.
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