GlaucomaSurgicalTreatments
MurrayFingeret,ODJustinSchweitzer,OD
JoeSowka,OD
Disclosures
• MurrayFingeret• ConsultantBausch&Lomb,Alcon,Allergan
• JustinSchweitzer• Allergan,Glaukos,BauschandLomb,Bio-Tissue,Alcon,TearScience,Reichert
• JosephSowka
GlaucomaSurgicalTreatments
• Whataretheindicationsforglaucomasurgery?(Murray)• SelectiveLaserTrabeculoplasty – Isitbestsuitedasaprimaryorsecondarytreatmentoption?(Murray)
• TheTrabeculectomy – Hasitbecomearelic?(Joe)• MIGS– TheiStent whatisitsrole?HasitbecomearelicwiththeintroductionofnewMIGSdevices?(Justin)
• MIGS- TheCypass andXengelimplant– WhataretheyandhowdotheydifferfromtheiStent? (Justin)
• Bimatoprost SR– Areinjectionsintotheanteriorchamberaviabletherapeuticoption?(Joe)
Whataretheindicationsforglaucomasurgery?
Whenissurgeryindicated?
• PoorIOPcontrol• Afterexhaustingmedicaltherapy,IOPisabovetargetpressure
• Glaucomatousdamagegettingworse• Poorcompliance
• Duetoahostofreasonsincludingcannotaffordmedication,cannotremembertotakethem
• Inabilitytoinstilleyedrops• Ie Parkinson'sdisease
• Medicationsideeffects• Thesemayalsobethereasonstoconsideradrugdeliverydevicewhenavailable
• Ring,punctal plug,contactlens,injection
Whenissurgeryindicated?
• IndicationsfordoingSLTaredifferentthanFiltrationsurgerywhicharedifferentfromimplantingaMIGSdevice
• Insurancecoveragemustbeconsidered• MuchquickertodoSLTorMIGS(ifcataractpresent)thanthetrabeculectomy
• SLTandMIGSareoftenconsideredasamedicationinregardstoindicationsandcomplications
Surgery• Lasertrabeculoplasty
• Selective• MIGS
• Istent• Cypass• Xengelimplant
• FilteringProcedures• Filteringprocedureswithanti-fibroblasticagents• Expressimplant• Canaloplasty• Implants
• Molteno,AhmedGlaucomaValve,Baerveldt GlaucomaImplant• Cyclophotocoagulation procedures
• Endocyclophotocoagulation
SelectiveLaserTrabeculoplastyIsitbestsuitedasaprimaryorsecondarytreatmentoption?
SelectiveLaserTrabeculoplasty (SLT)
• Q-switched,frequencydoubledNd:Yag 532nmlaser• Targetspigmentedcellsintrabecularmeshwork
• littledamagetonon-pigmentedcells• lessdestructiveprocedure
• 400µmspotsizew50spotsto180o ofTM• ascomparedto50µmspotsizeforALT• spansentireheightofTM• selectivelytargetspigmentedcellswocausingstructuralorcoagulationdamage
• eliminatesscarring• Reducedenergylevels- 0.6- 1.2mJ
Courtesy M. Latina, M.D.
The Differences between ALT & SLT Treatments
LaserSpotSizeDifferencesofALTandSLT
• ALT(greenarea)• RequiresfocusonTM
• SLT(redarea)• CoversTM• DoesnotrequiresamesensitivefocusasALT
• Larger beam diameter •reduces need for focus•evenly distributes laser energy
SelectiveLaserTrabeculoplasty(SLT)
• Advantage• LittledestructiontoTMsupportsbiologictheory
• Nocoagulationeffects• reducedincidenceofIOPspikesandcomplications
• Reliesonselectivephotothermolysis
• targetsmelaningranuleswithincell
• celldeathoccurs• Lessneedforpigmentedtissue
• 20-22%IOPreduction• Worksover24hourperiod• ReducedstructuraldamagetoTM
• IOPreducedat1week
SelectiveLaserTrabeculoplasty(SLT)
• Patienttype• Effectiveasadjunctiveorreplacementtx• Alsomaybeusedasprimarytherapy• Beingusedearlyinsteppedmedicaltherapy
• Donotwaituntilpatientexhaustedallmedicaloptions
• Contraindications• Secondaryglaucomas
• Traumaticanglerecession• Inflammatory• Neovascular
SLTResults
Author/Yr Eyes Response IOP Decrease
Latina,1998 53 70% 23.5%
Gracner,01 50 88% 21.6%
Melamed, 2003
45 96% 30%
Cvenkel,04 44 62% 17.1%
McIlraith, 2006
74 83% 31.0%
ShouldSLTbeusedasPrimaryTherapy?
• Advantagestoprimaryuse• Cost• Adherence• IOPloweringeffectwearsoffandquestionableifrepeatable• Lastsin50%approximately5years• Fewsideeffectsandrelativelysafe• Worksover24hourperiod
• Disadvantagestoprimaryuse• OnlyreducesIOP20%
• Advantagestosecondaryuse• Additivetoallothermedications• Canbeutilizediffirstlinetherapyunsuccessfulorneedsadditionalreduction
• Explainoptionstopatientandletthemhavevoiceinwheretherapyfits
IsitRepeatable?
Trabeculectomy– Hasitbecomearelic?
Trabeculectomy– Hasitbecomearelic?§Whatfilter(trabeculectomy)surgeryis
- FistulizationbetweenACandsubconjunctivalspace§ Indications
- Moderate/advanceddisease,veryhighinitialIOP,progressingdisease,needforlowandstableIOP
• (CIGTSprimaryprocedure?)
§ Risksandcomplications- Several
§ IsitbeingdonelesswithMIGSnowavailable?- Yes,butnotforthereasonsthatyouthink
Trabeculectomy
• Trabeculectomy(1968)+/- anti-metabolite• Blebformingprocedure• Longestablishedprocedurewithvastexperience
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Antifibrotic Agents§ Inhibitfibroblastproliferation
§ 5FU- Intraoperative: 50mg/mlfor5min- Postoperative: 5mgsubconj
§MMC- 100timesmorepotentthan5FU- Intraoperative: 0.2-0.5mg/mlfor2-5min
Antifibrotic Agents§ Inhibitfibroblastproliferation
- MMC;5-FU
§ Indications- Neovascularglaucoma- Uveiticglaucoma- Previousocularsurgery(e.g.CE,failedfilter)- AfricanAmericanrace- Youngage
• Goodhealing- NeedforaverylowIOP
• Veryadvanceddisease
Outcomes:TrabeculectomySuccessAfter20Years:
- 57%=completesuccess- 88%=qualifiedsuccess(w/meds)
Complications:- Cataract:55%- Lossof≥3linesofacuity:21%- Bleb-relatedproblems:10%- Infection:4%
Jampel HD. Ophthalmol 2012Gedde SJ. Arch Ophthal 2012
IstrabeculectomyaPanacea?§ TrabeculectomywillgivelowIOP
- Singledigits§ Longhistoryofsuccess§ Technicallystraightforwardprocess§ Eyeneverlooks/feelsthesame§ Potentialcomplications
EarlyComplications§ FailuretocontrolIOP- scarring§ Malignantglaucoma§ Hyphema§ Hypotonyresultingmaculopathy,suprachoroidalhemorrhage,choroidaleffusion,orshallowanteriorchamber
§ Woundleak,mayrequireadditionalsutures§ Endophthalmitisorblebitis§ Lossofvision
- “wipe-out”• Hypotonymaculopathy,choroidaleffusionanddetachment,pressurespike,idiopathic
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LateComplications§ Cataract
- Trabscausecataracts§ Ptosis§ Blebleak,duetobreakdownofconjunctivaoverthebleb,cancausehypotony
§ EndophthalmitisandBlebitis- riskincreaseswithblebleak
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Trabeculectomy§ Historicallyperformedbygeneralophthalmologists§ Asophthalmologyhasevolved,mostgeneralophthalmologistshaveabandonedtrabstoglaucomaspecialists
§ Establishedglaucomaspecialistshavenowlearnedtubesandseatons(drainageimplants)
§ Newerglaucomaspecialistsareincreasinglylearningdrainageimplants
§ So,yestraditionaltrabeculectomyisbecomingareliccomparedtodrainagedevices(notMIGS)
Drainagedevices/TubeShunts§ ACtube
- ShuntsaqueousfromACtoplate- Maintainspatencyoffistula
§ Episcleralplate(explant)- Locatedinequatorialregionofglobe
- Formsanonadherentcapsule
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DrainageDevices§ Ahmedvalve;Baerveldtimplant§Goodwhenprevioustrabfailedorisexpectedtofail§Nowbecomingpopularasaprimaryprocedure§ TVTStudy
- TrabwithMMCandtubeshuntcangivesustainedlowteenIOP
- TubeshunthasgreatersuccessthantrabwithMMCineyeswithpriorcataractand/orglaucomasurgery
- Similarsafetyprofiles- tubesbecomingpopular
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Drainagedevices§ Indications
- Neovascularglaucoma- Uveiticglaucoma- Previousocularsurgery(e.g.CE,failedfilter)- Perilimbalconjunctivalscarring- ICEsyndrome- Congenitalglaucomarefractorytoanglesurgery
Glaucomasurgicalprocedures
Glaucoma not well controlled
Mild disease,Concurrent cataract, desire to reduce med load
MIGS
Moderate/ advanced disease,High baseline IOP,Secondary glaucomasLow target IOP
Trabeculectomy Tube Implant
istrabeculectomybeingdonelesswithMIGSnowavailable?YesandNo
§MIGS≠Trabeculectomy- Easierwithfewercomplications- LesserIOPreduction- Inducementforalesserproceduretobedone?
• Delaysmoreneededprocedure?
§ Trabeculectomymaybegivingwaytotubes§ Trabeculectomywillbearoundforawhilelonger
MinimallyInvasiveGlaucomaSurgery(MIGS)
TheiStent - whatisitsrole?HaveyouMIGSdevicesreduceditsvalue?
SafetyFirstiStent
8%postopcornealedema3%elevatedIOP
SafetyprofilesimilartoCEx
Unmatchedsafetyprofilecomparedtonewlyapproveddevices?
TheCyPass andXenGelImplant
CyPass Micro-Stent
COMPASSStudy374SubjectsCyPass +CataractSurgery
IOP
Medications
Baseline 12Months
24.4mmHg
1.4
17mmHg
0.2
72.5% stent+cataractachieveda> 20%reductioninunmedicated diurnalIOPat2yearsvs58%incataractalone
Hypotony 2.9%@30daysOverallsaftey profilewassimilartoCEx
DUETTEStudy
65EyeswithmedicatedIOPgreaterthan21atbaseline
IOP
Medications
Baseline 12Months
24.5+/-2.8
2.2+/- 1.1
Mostcommonadverseevents:IOP>30beyond1month(11%),transienthyphema (6%)andcataractprogression(12%)
16.4+/-5.5
1.4+/-1.3
Xen
Xen 45GelStent:USPivotalClinicalTrialVisits– IOP andMedications Mean
Baseline
MedicatedIOP 25.1(3.7)
GlaucomaMeds 3.5(1.0)
12 Month
IOP 15.9(5.2)
GlaucomaMeds 1.7 (1.5)
76.3%ofpatientsreportedameandiurnalIOPreductionof
> 20%frommedicatedbaselineat12months
Hypotony 16(24.6%)(IOP<6mmHgatanytime)
Anteriorchambershallow 1(1.5%)withperipheralirido-cornealtouch
Anteriorchamberfill 1(1.5%)
Bleb Needling 21(32.3%)
PostoperativeAdverseEvents
Areinjectionsintotheanteriorchamberaviabletherapeutic
option?
Optionsfordrugdelivery
Evolutionofsustaineddelivery
§ Allerganiscurrentlyperformingphase3clinicaltrialsonitsbimatoprostsustained-releaseimplant(bimatoprostSR),whichisanintracameraldepotimplantinjectedintotheanteriorchamber.
§ Implantcomprisingaprostamideassociatedwithabiodegradablepolymermatrixthatreleasesanamountofaprostamide
bimatoprostSR§ Phase2trialsoftheimplantshowedmeanoverallIOPreductionsfrombaselinethroughweek16afterthefirstimplantationofthebimatoprostsustained-releasedevice
- 7.2,7.4,8.1,and9.5mmHgwiththe6-,10-,15-,and20-microgramdosescomparedwithan8.4mmHgdecreaseinthepooledfelloweyestreatedwithtopicalbimatoprost(0.03%).
bimatoprostSR• TheimplantloweredIOPin92%ofpatientsat4monthsand71%at6months.
• Didnotneedadditionalrescuetherapy
• Therewerenoseriousadverseocularevents• Themostcommonadverseeventwastransientconjunctivalhyperemia(mediandurationof5days),whichdevelopedwithin2daysaftertheimplantwasinjected.
• In24eyesthatdidrequireanothertreatmenttocontrolIOP,theoverallmeanIOPreductionfromthebaselineIOPwas8.0mmHgthrough16weeksaftertherepeatbimatoprostsustained-releasetreatment.
TravoprostSR
TravoprostSR
TravoprostSR§ ENV515- phase2aopen-label,28-daydose-rangingstudyof21patientsyielded28%IOPloweringatday25inonegroup,whichwascomparabletoonce-dailyTravatanZ
§ Envisiaisplanningtoadvancetoa12-monthstudytoevaluatethelong-termIOPloweringofENV515.
NotSoGreatThingsAboutSustainedDelivery
§ Injectablemedsandimplants- ifmeddoesn’tworktopicallyorhasadverseeffects,dropisstopped;can’teasilystopimplantabledevices.
§ Implantscantheoreticallyblockpartsoftheangle§ Complicationswithinvasiveoptions
- Endophthalmitis
§ Decreasedaccesstocare?
NotSoGreatThingsAboutSustainedDelivery• Limitations- howmanydrugscanyouloadintotheanteriorchamber?
• Drugsmayworkbetterinpulsatileformandnotsowellinconstantdelivery
• PGAslesseffectiveatBIDdosing- receptorsupersaturationanddesensitization
• Downtimebetweendropspreventsdesensitization• SomeconcentrationsofbimatoprostSRwerelesseffectivethantopical0.03%
NotSoGreatThingsAboutSustainedDelivery• SRproductsseemlesseffectivethandrops• Willinsurancepayforitjusttoincreasecompliance?
Anti-VEGFmodelforamd§ Comparedtoclinicaltrials,VAoutcomesareworseandtherearefewerinjectionsdoneintherealworld.Patientslosttofollow-uparedoingpoorly.
§ Dropoutrate20%-30%
Willpatientsgoforit?