Control of Inflammation and Prophylaxis of Endophthalmitis ... · Insufficient Midriasis 11 3.85...

Fabrizio Camesasca Fabrizio Camesasca –– Matteo PiovellaMatteo Piovella ASCRS 2006ASCRS 2006

Control of Inflammation and Control of Inflammation and Prophylaxis ofProphylaxis of EndophthalmitisEndophthalmitis After After

Cataract Surgery: aCataract Surgery: a MulticentricMulticentric Study Study Comparing the Comparing the BetamethasonBetamethason--

ChloramphenicolChloramphenicol vs.vs. TobramycinTobramycin--DexamethasoneDexamethasone


Matteo PiovellaMatteo Piovella11

Fabrizio CamesascaFabrizio Camesasca22

Costantino BianchiCostantino BianchiGiorgio BeltrameGiorgio Beltrame33

Aldo CaporossiAldo Caporossi44

Antonello RapisardaAntonello Rapisarda55

Giorgio TassinariGiorgio Tassinari66

Lucio ZeppaLucio Zeppa77

11 Centro Microchirurgia Oculare, MonzaCentro Microchirurgia Oculare, Monza22 U.O. Oculistica, Istituto ClinicoU.O. Oculistica, Istituto Clinico HumanitasHumanitas, Milano, Milano

33 Centro Medico San Biagio, Centro Medico San Biagio, FossaltaFossalta di Portogruaro di Portogruaro –– VeneziaVenezia44 Dipartimento del Distretto Cefalico e Scheletrico, Azienda OspeDipartimento del Distretto Cefalico e Scheletrico, Azienda Ospedaliera Universitaria daliera Universitaria

Senese, SienaSenese, Siena55 UnitUnitàà Complessa Oftalmologia, Azienda Ospedaliera Umberto I, SiracusaComplessa Oftalmologia, Azienda Ospedaliera Umberto I, Siracusa

6 6 U.O. Oculistica, Ospedale Maggiore di Bologna, BolognaU.O. Oculistica, Ospedale Maggiore di Bologna, Bologna77 U.O. Oculistica Azienda Ospedaliera S.G. Moscati, AvellinoU.O. Oculistica Azienda Ospedaliera S.G. Moscati, Avellino


The The Author aknowledgesAuthor aknowledges a a financialfinancial interest in the interest in the subject subject

mattermatter ofof this presentationthis presentation


Cataract SurgeryCataract Surgery

•• 460.000 interventions every year in Italy460.000 interventions every year in Italy•• Well established and standardized Well established and standardized

techniquetechnique•• Postoperative periodPostoperative period::

–– Control of inflammationControl of inflammation–– Prevention of endophthalmitis Prevention of endophthalmitis (300(300--400 cases/year in Italy)400 cases/year in Italy)


InflammationInflammation: : SteroidSteroid•• Most frequently usedMost frequently used•• PossiblePossible complicationscomplications of steroidsof steroids::

–– IncreasedIncreased intraocular pressureintraocular pressure–– DelayedDelayed healinghealing of cornealof corneal woundwound

•• ToTo reduce reduce administrationsadministrations and and increaseincreaseefficacyefficacy: gel: gel

•• Gel Gel has been showed to be has been showed to be more more efficient than efficient than acqueous solutionacqueous solution

Ghelardi E, Antimicrob Agents Chemother 2004;48:33906-401


EndophthalmitisEndophthalmitis::Antibiotic Antibiotic ASCRS ASCRS AnalysisAnalysis

•• OfloxacinOfloxacin•• OxyfloxacinOxyfloxacin•• GentamicinGentamicin•• TobramicinTobramicin•• etc.etc.

Leaming DV, J Cataract Refract Surg 2004;30:892-900


UseUse ofof Gel in Gel in OphthalmologyOphthalmology•• Use ofUse of gel gel isis basedbased on on physicalphysical and and

physiologicalphysiological theoriestheories•• RationalRational: : increasingincreasing drug permanencedrug permanence on on

the the ocular surfaceocular surface•• GreaterGreater pharmachological effectpharmachological effect•• ReductionReduction in in concentration concentration and and

administrationsadministrationsBianchi C, Monografie SOI, Anno X, Num. 1997, 83-4

Ghelardi E, Antimicrob Agents Chemoter 2004;48:3396-41Sultana Y, J Ocul Pharmacol Ther 2004;20:363-71


UseUse ofof Gel in Gel in OphthalmologyOphthalmology: : reducingreducing……

•• Loss Loss of complianceof compliance•• Side Side effectseffects•• Allergic reactionsAllergic reactions•• IOP IOP increase increase ((with steroidwith steroid))


Goal of the StudyGoal of the Study

Comparing clinical findingsComparing clinical findings and and patients satisfactionpatients satisfaction afterafter postpost--cataract surgerycataract surgery treatment treatment with with two different antibiotictwo different antibiotic//steroid steroid associationsassociations,, oneone in in acqueous acqueous

solutionsolution, the , the other other in gelin gel


Materials Materials and and MethodsMethods•• MulticentricMulticentric, , prospectiveprospective, , randomizedrandomized studystudy•• Patients undergoing bilateral cataract surgeryPatients undergoing bilateral cataract surgery•• AprilApril –– DecemberDecember 20052005•• Eight Centers Eight Centers in Italyin Italy


SurgeonsSurgeons and and CentersCentersMatteoMatteo PiovellaPiovellaCentro Microchirurgia Oculare, MonzaCentro Microchirurgia Oculare, Monza

Giorgio BeltrameGiorgio BeltrameCentro Medico San Biagio, Centro Medico San Biagio, FossaltaFossalta di Portogruaro di Portogruaro –– VeneziaVenezia

Aldo CaporossiAldo CaporossiDipartimento del Distretto Cefalico e Scheletrico, Azienda OspedDipartimento del Distretto Cefalico e Scheletrico, Azienda Ospedaliera Universitaria aliera Universitaria Senese, SienaSenese, Siena

Antonello Antonello RapisardaRapisardaUnitUnitàà Complessa Oftalmologia, Azienda Ospedaliera Umberto I, SiracusaComplessa Oftalmologia, Azienda Ospedaliera Umberto I, Siracusa

Giorgio TassinariGiorgio TassinariU.O. Oculistica, Ospedale Maggiore di Bologna, BolognaU.O. Oculistica, Ospedale Maggiore di Bologna, Bologna

Lucio ZeppaLucio ZeppaU.O. Oculistica Azienda Ospedaliera S.G. Moscati, AvellinoU.O. Oculistica Azienda Ospedaliera S.G. Moscati, Avellino


Inclusion CriteriaInclusion Criteria•• Bilateral cataractBilateral cataract•• BSCVA > = 0.2 BSCVA > = 0.2 logMARlogMAR

Exclusion CriteriaExclusion Criteria•Preoperative:

• Diabetes mellitus, sistemic steroids, uveitis, glaucoma, previous ocular surgery, subluxated lens, endotelial cellcount < 1000/mm2, midriasis < 5mm

•Intraoperative: • Posterior capsule break, anterior vitrectomy, iris capture, corneal suture


Surgical TechniqueSurgical Technique•• Standardized Standardized and and consistantconsistant in the in the CentersCenters::

–– TopicalTopical//peribulbar anesthesiaperibulbar anesthesia–– Temporal incisionTemporal incision–– CapsulorrhexisCapsulorrhexis–– IdrodissectionIdrodissection–– PhacoemulsificationPhacoemulsification–– I/AI/A–– FoldableFoldable IOLIOL–– Intraocular antibioticIntraocular antibiotic injectioninjection


Materials Materials and and MethodsMethods•• SecondSecond eyeeye undergoingundergoing surgerysurgery at at leastleast 7 7 daysdays

afterafter first first eyeeye surgerysurgery•• RandomizedRandomized postoperativepostoperative treatment:treatment:

–– Group 1 Group 1 –– chloramphenicolchloramphenicol 0.25% 0.25% -- betamethasonebetamethasone0.13% 0.13% GELGEL TRID (TRID (BetagelBetagel))

–– Group 2 Group 2 -- tobramycintobramycin 3% 3% -- dexamethasonedexamethasone 1% 1% EYEDROPSEYEDROPS QUID (QUID (TobradexTobradex))

–– ForFor 15 15 daysdays


MaterialsMaterials and and MethodsMethods•• FollowFollow--up up intervalsintervals: 1, 3, 7, 15 : 1, 3, 7, 15

daysdays•• Complete Complete ophthalmologicalophthalmological

examinationexamination•• EvaluationEvaluation of subjectiveof subjective

impressionsimpressions of eachof each patientpatient


Monitored Surgical ParametersMonitored Surgical Parameters•• AnesthesiaAnesthesia•• Temporal incision Temporal incision •• CapsulorrhexisCapsulorrhexis•• Type and model of IOLType and model of IOL•• Intraocular antibioticIntraocular antibiotic•• Drugs in the infusionDrugs in the infusion•• Time of surgeryTime of surgery•• Time of ultrasounds Time of ultrasounds •• Type of viscoelasticType of viscoelastic•• Type of phacoType of phaco•• Intracamerular myotic drugIntracamerular myotic drug•• Intraoperative complicationsIntraoperative complications


ResultsResults•• 284 284 eyes ofeyes of 142 142 patients patients •• AgeAge ((meanmean ±± SD): 73.7 SD): 73.7 ±± 8.9 yrs8.9 yrs•• Age range: 43 Age range: 43 –– 91 yrs91 yrs•• Sex: 53 males (37.06%), 90 females (62.94%)Sex: 53 males (37.06%), 90 females (62.94%)•• Disinfection of periocular skin and conjunctival sac Disinfection of periocular skin and conjunctival sac

with with iodopovidone iodopovidone •• Anesthesia: topical 263, peribulbar 2Anesthesia: topical 263, peribulbar 211•• Time ofTime of US: US:

–– 70.64 70.64 ±± 3.42 sec (Group 1) 3.42 sec (Group 1) –– 68.80 68.80 ±± 3.31 sec (Group 2) (n.s.).3.31 sec (Group 2) (n.s.).


Preoperative Clinical DataPreoperative Clinical Data

Group 1 Group 1 BetagelBetagel

(mean (mean ±± S.D.)S.D.)

Group 2Group 2TobradexTobradex

(mean (mean ±± S.D.)S.D.)

pp

IntraocularIntraocularPressurePressure

15.55 15.55 ±± 2.522.52 15.62 15.62 ±± 2.832.83 n.s.n.s.

PupilPupilDiameterDiameter(mm)(mm)

7.12 7.12 ±± 1.711.71 7.40 7.40 ±± 1.091.09 n.s.n.s.

Endotelial CellEndotelial CellCountsCounts, , meanmean

2124.03 2124.03 ±± 431.76431.76 2150.34 2150.34 ±± 441.71441.71 n.s.n.s.

Endotelial Cell Endotelial Cell CountsCounts, Standard , Standard DeviationDeviation

186.92 186.92 ±± 87.9587.95 185.78 185.78 ±± 90.0490.04 n.s.n.s.

UCVA UCVA logMARlogMAR 0.70 0.70 ±± 0.490.49 0.73 0.73 ±± 0.480.48 n.s.n.s.


Duration of SurgeryDuration of SurgeryFirst EyeFirst Eye Second EyeSecond Eye

casescases casescases

< 15 min< 15 min 8080 9999

betweenbetween 15 and 15 and 20 min20 min

4646 2323

> 20 min> 20 min 00 00

TotalTotal 142142 142142


Intraoperative ComplicationsIntraoperative Complications

ComplicationComplication Number of casesNumber of cases %%

InsufficientInsufficient Midriasis Midriasis 1111 3.853.85Anterior chamber unstabilityAnterior chamber unstability 44 1.401.40IrisIris prolapseprolapse 11 0.350.35Difficult Difficult IOL IOL insertioninsertion 99 3.153.15Iris Iris chafechafe 00 00Posterior Posterior capsule breakcapsule break 00 00VitrectomyVitrectomy 00 00Corneal wound Corneal wound suturesuture 00 00


PostoperativePostoperative DataDataIOPIOP

12,00

12,50

13,00

13,50

14,00

14,50

15,00

15,50

16,00

1 3 7 15

BetagelTobradex

mmHgmmHg

daysdays

P= n.s.


PostoperativePostoperative DataDataTyndallTyndall

((gradinggrading: 1 : 1 -- 4)4)

0,000,050,100,150,200,250,300,350,400,45

1 3 7 15

BetagelTobradex

daysdays


PostoperativePostoperative Data Data ((gradinggrading: 1 : 1 -- 4)4)

0,000,050,100,150,200,250,300,350,400,450,50

1 3 7 15

BetagelTobradex

LidLid and/or and/or ConjuctivalConjuctival EdemaEdema

0,000,100,200,300,400,500,600,700,800,90

1 3 7 15

BetagelTobradex

LidLid and/or and/or ConjuctivalConjuctival CongestionCongestion

daysdays

daysdays


PostoperativePostoperative Data Data ((gradinggrading: 1 : 1 -- 4)4)

0,00

0,10

0,20

0,30

0,40

0,50

0,60

1 3 7 15

BetagelTobradex

Reduced Corneal Reduced Corneal Transparency

0,00

0,10

0,20

0,30

0,40

0,50

0,60

0,70

1 3 7 15

BetagelTobradex

Corneal Corneal EdemaEdema

daysdays

daysdays

Transparency


Subjective Subjective DataDataPain Pain

((GradingGrading 00--10)10)

0,001,002,003,004,005,006,007,008,009,00

10,00

1 3 7 15

BetagelTobradex

daysdays


SubjectiveSubjective DataDataDry Dry EyeEye (%)(%)

0,00

5,00

10,00

15,00

20,00

25,00

30,00

35,00

1 3 7 15

BetagelTobradex

P= n.s.

daysdays


SubjectiveSubjective DataDataSensationSensation After InstillationAfter Instillation

No No changechange

%%

UnpleasantUnpleasant%%

PleasantPleasant%%

BetagelBetagel 23.2423.24Sensation Sensation change after change after instillationinstillation

TobradexTobradex 27.4627.46 7.757.75 64.7964.79

.04.04

2.112.11 74.6574.65

pp


ConclusionsConclusions –– PostPost--Cataract Cataract Surgery TherapySurgery Therapy

•• SteroidSteroid//antibioticantibiotic associationassociation: diffuse and : diffuse and wellwellacceptedaccepted useuse

•• Chloramphenicol featuresChloramphenicol features goodgood intraocular intraocular penetrationpenetration, , antibacterialantibacterial spectrum adequate spectrum adequate for for common common pathogenspathogens

•• betamethasonebetamethasone andand dexamethasone have dexamethasone have similar potency similar potency and and duration of actionduration of action

Leaming DV, J Cataract Refract Surg 2004; 30:892-900Lum F, Ophthalmology 2000; 107:691-7


ConclusionsConclusions•• Two completely comparable Two completely comparable

GroupsGroups•• BiasBias factorsfactors: : minimizedminimized•• Evaluation of all parametersEvaluation of all parameters related related

toto postoperativepostoperative treatmenttreatment


ConclusionsConclusions•• Postoperative painPostoperative pain: no : no significant significant

difference difference •• Gel Gel preparationpreparation waswas subjectivelysubjectively more more

pleasantpleasant (p= .04(p= .04))•• Identical clinical results with Identical clinical results with gel TRID gel TRID

vs.vs. eyedropseyedrops QUIDQUID•• No No allergic reaction allergic reaction or side or side effecteffect


ConclusionsConclusions•• ChloramphenicolChloramphenicol 0.25% 0.25% --

betamethasonebetamethasone 0.13% gel 0.13% gel associationassociationproved to have similar efficacyproved to have similar efficacy and and tolerance but better patient tolerance but better patient acceptance thanacceptance than tobramycintobramycin 0.3% 0.3% ––dexamethasonedexamethasone 0.1% 0.1% associationassociation in in acqueousacqueous solutionsolution..


Thank You For Your Thank You For Your Attention Attention !!

Control of Inflammation and Prophylaxis of Endophthalmitis ... · Insufficient Midriasis 11 3.85...

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Transcript of Control of Inflammation and Prophylaxis of Endophthalmitis ... · Insufficient Midriasis 11 3.85...