Pre-loaded DMEK Tissue - Eversight

Pre-loadedDMEKTissueShahzad Mian,M.D.,UniversityofMichigan

LaurenJohnson,EversightDirectorTraining&Education

DMEKvs.DSEK

DSEKDMEK

Tissueadditive Tissueneutral

EndothelialKeratoplasty

Endothelialdysfunction/cornealedema

01,0002,0003,0004,0005,0006,0007,000

2012 2013 2014 2015 2016

Tran

splants

Year

DescemetMembraneEndothelialKeratoplasty

DMEK• Overthepast3years,therehasbeenasharpincrease

inthenumberofDMEKsurgeriesbeingperformed

2015EyeBankingStatisticalReport.EyeBankAssociationofAmerica.2016.WashingtonDC.

103.5%

88.2%

63.8%

37.6%

Hamzaoglu EC,Straiko MD,Mayko ZM,SálesCS,TerryMA.Ophthalmology.

2015;122(11):2193-9.

N=200;First100casesofeachprocedure

(retrospectivecaseseries).

DMEK– improvedvisualacuity

DMEK– Reducedrejectionrisk

Anshu A,PriceMO,PriceFW.Ophthalmology.2012;119(3):536-40.

DMEK• DMEKstillonlyaccountsfor23%ofallEKproceduresperformedintheUS

0

5,000

10,000

15,000

20,000

25,000

2012 2013 2014 2015 2016

Tran

splants

Year

EndothelialKeratoplasty (EK)

DMEK DSAEK

DMEK

• DMEKisatechnicallydifficultsurgery–Newsurgicalmaneuvers–DMEKgrafttissueisveryfragile•Minimizemanipulation

Sowhydon’twedoDMEKoneverycase?

DMEK

• Optimaltissuedelivery– Prestrippedandpretrephined• Eye-bankpreparationofprestripped tissuehasaidedinacceptanceandincreasedconversiontoDMEK– SimilartoprecutDSAEKnearlyadecadeago

DMEK

• Optimaltissuedelivery–Prestrippedandpretrephined–Preloaded• Containertype• Trypan staining

PURPOSE

• Todeterminetheendothelialsafetyofpre-stainingDMEKgraftswithTrypanBluepriortopreloading

WolleM,DeMillD,WoodwardM,Mian,S.TheEndothelialSafetyofUsingPreloadedDescemetMembraneEndothelialKeratoplasty Graft.Cornea (inpress)

METHODS• Twentysevencadavericcorneas• PreparedforDMEKusingastandardizedtechnique– ExperiencedDMEKeyebanktechnician

METHODS• Twentysevencadavericcorneas

• PreparedforDMEKusingastandardizedtechnique

• LoadedinStraiko ModifiedJonesTubeinjector(GuntherWeissScientificGlass,Portland,OR)– FilledwithOptisolGS

METHODS

• Twentysevencadavericcorneas

• PreparedforDMEKusingastandardizedtechnique

• LoadedinStraikoModifiedJonesTubeinjector

• Storedwithsiliconecapscoveringeachend

METHODS• Corneasdividedintothreegroupsofnine

– Group1—Preloadedprestained DMEKGraft(psDMEK)• Pre-stainedwithTrypan Blue0.06%(DORCInternational) for3minutespriortopreloadingandstorageinthemodifiedjonestubefor24hours

– Group2—PreloadedDMEKGraft(pDMEK)• Directlypreloadedintheinjectorpriortostoragefor24hours

– Group3—ImmediatelyInjectedDMEKGraft(Control)• Immediatelyinjectedintovitaldye

RESULTS

RESULTS• AppearanceofpreloadedandprestainedDMEKtissueafter24hoursofstorage

RESULTS

Table1.EndothelialCellLoss(%)*PreloadedprestainedDMEK Grafts(Group 1)

PreloadedDMEK Grafts(Group 2)

ImmediatelyInjectedDMEKGrafts-Control(Group3)

Average(SD) 16.78(7.11) 20.16(7.52) 18.47(6.36)Range 6.86—32.27 12.81—33.29 10.27—30.50p-value 0.67 0.57 REF

CONCLUSION

• DMEKtissuecanbestoredinOptisolGSwithintheStraiko ModifiedJonesTubefor24hourswithoutincreasedECL

• Prestaining DMEKtissuewithTrypan Blue0.06%priortopreloadingdoesnotresultinincreasedECL

• DMEKGraftsretainsufficientbluecolorationafter24hours

SurgicalTechnique

PURPOSE

• Pilotstudytoassessfeasibilityandefficacyofpre-loadedcornealdonorgraftsforDescemetMembraneEndothelialKeratoplasty

Methods

• Prospectivestudy• Eyebankpre-stripped,pre-stained,pre-trephineddonortissue

• Outcomemeasures– Primaryendpoints:ratesofdetachment,primarygraftfailure,rebubbling

– Secondaryendpoint:specularmicroscopyat3months

RESULTS• 14eyesof13patients• Followup:7weeks(1weekto3months)• PrimaryEndpoints– Detachment:4/14(28.6%)– Rebubble:1/14(7.1%)– Primarygraftfailure:0/14

• SecondaryEndpoints– Specularat3months:– MeanECD2530(-11.4%)

Complications

• CME:1/14(ERM)• Pupillaryblock:1/14

Summary

• Pre-stripped,pre-stained,pre-loadedDMEK(p3DMEK)maybeasafeandefficaciousalternative

TrainingResources

www.eversightvision.org/onlinetraining

Journalarticles,tissueprepoptions,demonstrationvideosandmore

Questions?