advanced kc surgical mx aoa 2015 cc 3rd edit...page 2 mechanical trauma in predisposed individuals...

Advanced Keratoconus Treatments – Not Just Contact Lenses Anymore

Cornea & Laser Eye Institute- Hersh Vision GroupCenter for Keratoconus

Hersh Vision GroupHersh Vision Group

Clark Y. Chang, O.D., MSc, FAAOClark Y. Chang, O.D., MSc, FAAODirector, Contact Lens ServiceDirector, Contact Lens ServiceCenter for Center for KeratoconusKeratoconus ––Cornea Cornea & Laser Eye Institute& Laser Eye InstituteTeaneck, NJTeaneck, NJ

Andrew Morgenstern, O.D., FAAOAndrew Morgenstern, O.D., FAAOOptometric Subject Matter Expert Optometric Subject Matter Expert BAH Contract Support:BAH Contract Support:Vision Center of ExcellenceVision Center of ExcellenceWalter Reed NMMCWalter Reed NMMCBethesda, MD Bethesda, MD

AllerganAllergan

Oasis Oasis Medical Medical Inc.Inc.

SynergEyesSynergEyes Inc.Inc.

DisclosuresDisclosuresClark Y Chang, OD, MSc, FAAOClark Y Chang, OD, MSc, FAAO


Special Thanks: Peter S. Special Thanks: Peter S. HershHersh, M.D., M.D. Medical Monitor, Medical Monitor, AvedroAvedro Inc.Inc.

DisclosuresDisclosuresAndrew Morgenstern, OD FAAOAndrew Morgenstern, OD FAAO

AlconAlcon

AllerganAllergan

GlaukosGlaukos


OasisOasis

OcusoftOcusoft

OculusOculus

TLCTLC

Vision Expo East/WestVision Expo East/West

Progressive apical Progressive apical thinning with inferior thinning with inferior conical protrusionconical protrusion

NNonon--vascularized? vascularized?

NNonon inflammatory?inflammatory?

Advanced KC Treatment StrategiesAdvanced KC Treatment Strategies““Classic” ManifestationsClassic” Manifestations


NNonon--inflammatory?inflammatory?

Bilateral but AsymmetricBilateral but Asymmetric True Unilateral True Unilateral KC?KC?

Irregular Cylinder & HOAIrregular Cylinder & HOA Vertical Vertical ComaComa

Spherical Spherical AberrationsAberrations

Onset ~ 1Onset ~ 1stst -- 22ndnd decade of life decade of life and slows down ~ 4and slows down ~ 4thth decadedecade

SStabilization trend ≠ absolutetabilization trend ≠ absolute

Incidence ≥ 1/2000?Incidence ≥ 1/2000?

Advanced KC Treatment StrategiesAdvanced KC Treatment Strategies““Classic” ManifestationsClassic” Manifestations


Multifactorial causesMultifactorial causes Genetic?Genetic? Trauma? Trauma? IOP?IOP?

LVC implications?LVC implications? FFKCFFKC Topo WNL but Family Topo WNL but Family HxHx

RabinowitzRabinowitz et. al et. al

0 1 2 3 4

Topo Pattern

WNL/SBT ABT Inferior Steepening/SRA

Abnormalie, FFKC

RSB(Stromal Bed)

≥ 300µm 280 - 299µm 260 -279µm

240 –259µm

< 240µm


Age ≥ 30 26 – 29 22 - 25 18 - 21

CT ≥ 510µm 481 -510µm

451 -480µm

< 450µm

MRSE ≤ -8D ≤ 10D ≤ -12D ≤ 14D > 14D

1. Randleman JB, Trattler WB, Stulting RD. Validation of the Ectasia Risk Score System for 1. Randleman JB, Trattler WB, Stulting RD. Validation of the Ectasia Risk Score System for preoperative laser in situ keratomileusis screening. Am J Ophthalmol. 2008 May;145(5):813preoperative laser in situ keratomileusis screening. Am J Ophthalmol. 2008 May;145(5):813--8.8.

Mechanical trauma in predisposed Mechanical trauma in predisposed individualsindividuals

IOP Spikes IOP Spikes

Increased surface temperature Increased surface temperature I fl tI fl t di tdi t

Advanced KC Treatment Advanced KC Treatment StrategiesStrategiesMultifactorial EtiologiesMultifactorial Etiologies


–– Inflammatory Inflammatory mediators mediators

–– ILIL--1/IL1/IL--6, MMPs, TNF6, MMPs, TNF--αα

–– Proteolytic enzymesProteolytic enzymes

Contact lens trauma?Contact lens trauma?

Sleeping posture?Sleeping posture?

keratocytekeratocyte apoptosisapoptosis

Reduced biomechanics! Reduced biomechanics!

Traditional Challenges in KC Traditional Challenges in KC MxMx

Bi h i lBi h i l I lI l

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesChallenges In Conventional Challenges In Conventional MxMx


BiomechanicalBiomechanical IrregularIrregular

WeakeningWeakening Optics Optics ProgressionProgression

══┼┼

Retarded

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesChallenges In Conventional Challenges In Conventional MxMx: Refractive: Refractive


┼┼

AberratedWavefront

Advanced

MarsackMarsack, JD, JD

Increased HOA (5.5x vs. control)vertical coma, trefoil, tetrafoil, and 20 astigmatism1,2

1.1. PantanelliPantanelli S et al. Characterizing the S et al. Characterizing the wavefrontwavefront aberration with aberration with keratoconuskeratoconus or penetrating or penetrating keratoplastykeratoplasty using a highusing a high--dynamic range of dynamic range of wavefrontwavefrontsensor. Ophthalmology. 2007;114:2013sensor. Ophthalmology. 2007;114:2013--20212021

2.2. KosakiKosaki R et al. Magnitude and orientation of R et al. Magnitude and orientation of zernikezernike terms in patients with terms in patients with KeratoconusKeratoconus. Invest . Invest OphthalmolOphthalmol Vis Sci. 2007;48:3062Vis Sci. 2007;48:3062--30683068

12.9 hrs/wk when absenteeism and presenteeismreviewed in working Americans with low vision1

Corneal diseases ranked 5th major eye diseases

Growing Accumulations of Stress and Development of “PITA” Syndrome Due to:

Visual FrustrationPhysical Frustration

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesChallenges In Conventional Challenges In Conventional MxMx: QOL: QOL


1.1. Jacobson G, Frick K, Jacobson G, Frick K, MassofMassof R. Impact of Low Vision and Chronic Ophthalmic Conditions on Absenteeism and Lost Work Productivity R. Impact of Low Vision and Chronic Ophthalmic Conditions on Absenteeism and Lost Work Productivity 2005;22:abstract no. 4117. Available at http://gateway.nlm.nih.gov/MeetingAbstracts/ma?f=103623580.html (accessed on 12/02/202005;22:abstract no. 4117. Available at http://gateway.nlm.nih.gov/MeetingAbstracts/ma?f=103623580.html (accessed on 12/02/2011)11)

2.2. JavittJavitt JC, Zhou Z, JC, Zhou Z, WillkeWillke RJ. Association Between Vision Loss and Higher Medical Care Cost in Medicare Beneficiaries. Ophthalmology RJ. Association Between Vision Loss and Higher Medical Care Cost in Medicare Beneficiaries. Ophthalmology 2007;114:2382007;114:238--245245

Indirect health care cost estimated at Indirect health care cost estimated at $2.14 billion $2.14 billion for Medicare beneficiaries in 2003for Medicare beneficiaries in 200322

Misperceived as small public health impact CLEK Study (CLEK Study (7373) vs. AMD 3 () vs. AMD 3 (9090) vs. AMD 4 () vs. AMD 4 (7171))

Physical FrustrationPsychological Frustration

Early Detection & Interdisciplinary Co-ManagementAre Keys to Optimizing Patient Outcome!!

1) Patient Monitoring Approach 1) Patient Monitoring Approach –– Refractive CorrectionRefractive Correction

2) Prophylaxis Approach 2) Prophylaxis Approach –– StabilizationStabilization

±± progression & ageprogression & age

33) Functional Approach ) Functional Approach –– Stabilization + Ref. CorrectionStabilization + Ref. Correction

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesExpanding Expanding Management ParadigmManagement Paradigm1) Patient Monitoring Approach 1) Patient Monitoring Approach –– Refractive CorrectionRefractive Correction


Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesAnatomical/Optical Signs: ExamplesAnatomical/Optical Signs: Examples

Munson’s Munson’s Sign/Sign/Rizzuti’sRizzuti’s signsign

Fleischer Fleischer Ring/Ring/HydropsHydrops/Corneal /Corneal scarscar

Scissor Scissor Reflex/Oil droplet Reflex Reflex/Oil droplet Reflex

““Warped” Mires on Warped” Mires on keratometrykeratometry//photokeratoscopyphotokeratoscopy ““Warped” Mires on Warped” Mires on keratometrykeratometry//photokeratoscopyphotokeratoscopy


Lower SpecificityLower Specificityifif SolelySolely UsingUsing

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesTopography: Hotspot Recognition!Topography: Hotspot Recognition!


S/P DecenteredSunRise LTK

HSV Corneal Scar

Emerging KCEmerging KC

if if SolelySolely Using Using Color Pattern Recognition Via Color Pattern Recognition Via

Anterior Corneal Anterior Corneal Topographical ProfilesTopographical Profiles

Video Courtesy Mike TulloVideo Courtesy Mike Tullo

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesPachymetryPachymetry/Tomography/Tomography

Ultrasound Ultrasound PachymetryPachymetry (5262 Eyes)(5262 Eyes) AvgAvg. CT = 544 . CT = 544 ±± 3434 um um Suspect Suspect if < 476 um if < 476 um CCT is Least reliable indicatorCCT is Least reliable indicator

Gl b l D l hi P lGl b l D l hi P l


–– Global Delphi PanelGlobal Delphi Panel–– KC with normal CCTKC with normal CCT

Optical Optical PachymetryPachymetry CT CT Distribution and Distribution and ElevationElevation Epithelial Epithelial masking of anterior masking of anterior curvaturescurvatures

–– Color Color Pattern Recognitions!! Pattern Recognitions!! –– Posterior Posterior Profiles and HOAs (Profiles and HOAs (ieie, V. Coma, V. Coma))

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPachymetryPachymetry/Tomography/Tomography

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Dynamic Bidirectional Dynamic Bidirectional ApplanationApplanation

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCorneal BiomechanicsCorneal Biomechanics


Dynamic Bidirectional Dynamic Bidirectional ApplanationApplanation

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCorneal BiomechanicsCorneal Biomechanics

Hersh Vision GroupHersh Vision GroupImage Courtesy of Renato Image Courtesy of Renato Ambrosio, MD, PhDAmbrosio, MD, PhD

Normal Thin cornea Normal Thin cornea KeratoconusKeratoconus

( 1, -1) ( 1, 1)

1st

2nd

Podium PresentationsPodium PresentationsZernike Chart

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesWavefrontWavefront AberrometryAberrometry


( 2, -2) ( 2, 0) ( 2, 2)

( 3, -3) ( 3, -1) ( 3, 1) ( 3, 3)

( 4, -4) ( 4, -2) ( 4, 0) ( 4, 2) ( 4, 4)

3rd

4th

Higher order aberrations make up approximately Higher order aberrations make up approximately 17% 17% of the total aberrations of normal eyesof the total aberrations of normal eyes

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesHigh Frequency Ultrasound: ArtemisHigh Frequency Ultrasound: Artemis


ReinsteinReinstein DZ, Archer TJ, DZ, Archer TJ, GobbeGobbe M, Silverman RH, Coleman DJ. M, Silverman RH, Coleman DJ. Epithelial thickness in Epithelial thickness in normal Cornea: three dimensional display with Artemis very high frequency digital normal Cornea: three dimensional display with Artemis very high frequency digital ultrasoundultrasound. J Refract . J Refract SurgSurg 2008;24:5712008;24:571--581581


2) 2) Prophylaxis Approach Prophylaxis Approach –– StabilizationStabilization

33) Functional Approach ) Functional Approach –– Stabilization + Ref. CorrectionStabilization + Ref. Correction

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesExpanding Expanding Management ParadigmManagement Paradigm


UV + Riboflavin (vitamin B2): 1UV + Riboflavin (vitamin B2): 1stst reported at U of reported at U of Dresden; many other studies ongoing since 1994Dresden; many other studies ongoing since 1994

Theo SeilerTheo Seiler

Eberhard Eberhard SpoerlSpoerl

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL/Corneal CrossCXL/Corneal Cross--linkinglinking


Gregory Gregory WollensakWollensak

908070605040

UV-irradiationwith riboflavin

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Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Riboflavin Absorption SpectrumCXL: Riboflavin Absorption Spectrum


0

1

2

300 350 400 450 500 550

wavelengthwavelength (nm)(nm)

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: UVA 365/370nmCXL: UVA 365/370nm


AvedroAvedro -- USAUSA

CXLUSA CXLUSA -- USAUSA

PeshkePeshke

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Different DevicesCXL: Different Devices


IROC IROC InnocrossInnocross

SooftSooft

Vega XVega X--LinkLink

*Web*Web--links are on links are on www.ocxls.orgwww.ocxls.org

Strengthens/stiffens corneas with UV Strengthens/stiffens corneas with UV light and riboflavin dropslight and riboflavin drops

9898--99% 99% effective*effective*

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Outcomes and indicationsCXL: Outcomes and indications


**RaiskupRaiskup--Wolf F, et. al .Collagen crosslinking with riboflavin and ultravioletWolf F, et. al .Collagen crosslinking with riboflavin and ultraviolet--A lightA lightin keratoconus: Longin keratoconus: Long--term results. J Cataract Refract Surg. 2008 May;34(5):796term results. J Cataract Refract Surg. 2008 May;34(5):796--801.801.

Goal: prevent corneal ectasia Goal: prevent corneal ectasia from progressing to penetrating from progressing to penetrating keratoplastykeratoplasty

Indications:Indications:



KeratoconusKeratoconus Pellucid Marginal DegenerationPellucid Marginal Degeneration PostPost--Refractive Surgery ectasiaRefractive Surgery ectasia Corneal meltingCorneal melting Infectious keratitisInfectious keratitis

Riboflavin/UVARiboflavin/UVA



Anterior ViewAnterior View Posterior ViewPosterior View

Riboflavin aloneRiboflavin alone

Riboflavin aloneRiboflavin aloneRiboflavin/UVARiboflavin/UVA

Riboflavin + UVA vs. Riboflavin alone, 30min treatmentRiboflavin + UVA vs. Riboflavin alone, 30min treatment

AsotaAsota, , FantFant, , EdelhauserEdelhauser, and , and StultingStulting, unpublished, unpublished

LASIK AND CXLLASIK AND CXL LASIK AND CXLLASIK AND CXL



UNEVEN RIBO UNEVEN RIBO DISTRIBUTIONDISTRIBUTION CXL WITH CKCXL WITH CK



CXL Outcome in the US:CXL Outcome in the US:A Single Center ReviewA Single Center Review


Treatment Decision

Stable Disease

BSCVA > BSCVA ≤

Progressive Disease

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Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesCXL Algorithm: Work in ProgressCXL Algorithm: Work in Progress


BSCVA > 20/40

Maximum K

< 55D

NO Independent Risk Factors

Independent Risk Factors

Maximum K

≥ 55D

BSCVA ≤ 20/40

Monitor? CXL?CXL? CXL?CXL? CXLCXL CXLCXL

Consider Consider BSCVA?BSCVA?

PKPPKPRisk Risk Factor?Factor?

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Epithelium has to be removed for CXLEpithelium has to be removed for CXL

Wait till Wait till ectasiaectasia progresses before CXLprogresses before CXL

Older patients don’t benefit from CXLOlder patients don’t benefit from CXL

Insurance will pay for CXL soonInsurance will pay for CXL soon

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: MythsCXL: Myths


p yp y

CXL effect is temporaryCXL effect is temporary

CXL not approved because it’s dangerousCXL not approved because it’s dangerous

0.65 J/cm2

70 J/cm2

70 J/cm2 7.7 J/cm2

Damage thresholds

Radiant exposures

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Possible Complications/ConcernsCXL: Possible Complications/Concerns


0.46 J/cm2 (9 %)

0.33 J/cm2 (7 %)

0.14 J/cm2 (2.1%)

0.12 J/cm2 (1.9%)

Radiant exposures

5.4

J/c

m2

Radiant Energy is Radiant Energy is Below Damage Below Damage

ThresholdThreshold

Real World UVReal World UV

All Exposed Tissues:All Exposed Tissues: 170170--200J/cm200J/cm22/day in 3/day in 3--4 4 hrshrs outdoors outdoors



yy

~60J/cm~60J/cm22/day of solar UVA/day of solar UVA

CorneaCornea 5J/cm5J/cm22 in 15in 15--20 min in Summer 20 min in Summer

CXL exposure=3 CXL exposure=3 mJmJ/cm/cm22

InfectionInfection EpiEpi--off only reportedoff only reported

Corneal Haze and ScarringCorneal Haze and Scarring EpiEpi--off only reportedoff only reported

P i f diP i f di



Progression of diseaseProgression of disease Intraocular InflammationIntraocular InflammationWorsening of refractionWorsening of refraction Inability to tolerate contact lensesInability to tolerate contact lensesNeed for PKPNeed for PKP

EpiEpi--OnOn Longer “load time”Longer “load time” Late stage techniqueLate stage technique More More riboribo neededneeded

EpiEpi--OffOff Shorter “load time”Shorter “load time” Early adopted Early adopted

techniquetechniqueLL ibib d dd d

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: EpiCXL: Epi--Off Vs EpiOff Vs Epi--On DebateOn Debate


No epi defectNo epi defect Less chance of Less chance of

infection and hazeinfection and hazeNo reported No reported

complicationscomplications

Less Less riboribo neededneeded Large epi defectLarge epi defect Slower recoverySlower recovery Higher risk of Higher risk of

infection and hazeinfection and haze Reported Reported

complicationscomplications

ParaCelParaCel TransepithelialTransepithelial CXL CXL Treatment KitTreatment Kit

0.250.25% Riboflavin% Riboflavin--55--Phosphate, Phosphate, HPMC, HPMC, Permeability EnhancersPermeability Enhancers


&&

0.250.25% Riboflavin% Riboflavin--55--Phosphate, Saline Phosphate, Saline Dextran freeDextran free

Two stage application procedure for Two stage application procedure for optimal riboflavin penetration and optimal riboflavin penetration and

excellent patient comfortexcellent patient comfort


Slit beam image of riboflavin penetrance following 4 minute soak ParaCel, 6 minute soak VibeX Xtra

Fine diffuse SPK indicating adequate epithelial disruption following 4 minute soak with ParaCel.

Images Courtesy: Mr Imran Rahman

The ParaCel™ / KXL™ System is not approved for sale in the United States

Hashemi H, Seyedian MA, Miraftab M et al. Corneal collagen cross-linking with riboflavin and ultraviolet a irradiation for keratoconus: long-term results. Ophthalmol 2013 Aug;120(8):1515-20.

DESIGN: : To evaluate the longTo evaluate the long--term results of corneal collagen crossterm results of corneal collagen cross--linking (CXL) in linking (CXL) in patients with progressive patients with progressive keratoconuskeratoconus (40 eyes, 32 KC) patients (40 eyes, 32 KC) patients ..

MAIN OUTCOME MEASURES:: BCVABCVA UCVA MRSE maxUCVA MRSE max K meanK mean K CCT andK CCT and

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Long Term OutcomesCXL: Long Term Outcomes


MAIN OUTCOME MEASURES: : BCVABCVA, UCVA, MRSE, max, UCVA, MRSE, max--K, meanK, mean--K, CCT, and K, CCT, and anterior and posterior elevation at the anterior and posterior elevation at the apex (baselineapex (baseline; 1, 3, 6 months after CXL; 1, 2, ; 1, 3, 6 months after CXL; 1, 2, 4, and 5 years 4, and 5 years later). later).

RESULTS: The The meanmean--K, maxK, max--K, UCVA, and astigmatism showed no change over K, UCVA, and astigmatism showed no change over time during these 5 years. After the first year, BCVA, MRSE, and CCT showed no time during these 5 years. After the first year, BCVA, MRSE, and CCT showed no change and stabilized, whereas elevation readings continued to decrease up to 5 change and stabilized, whereas elevation readings continued to decrease up to 5 years after CXL.years after CXL.

CONCLUSIONS: Treatment Treatment of progressive of progressive keratoconuskeratoconus with CXL can stop disease with CXL can stop disease progression, without raising any concern for safety, and can eliminate the need for progression, without raising any concern for safety, and can eliminate the need for keratoplastykeratoplasty..

Purpose: Riboflavin and ultraviolet: Riboflavin and ultraviolet--A induced A induced cross linking (CXL) is a promising therapeutic cross linking (CXL) is a promising therapeutic

Theuring A, Spoerl E, Pillunat LE, Raiskup F. [Corneal collagen cross-linking with riboflavin and ultraviolet-A light in progressive keratoconus. Results after 10-year follow-up]. Ophthalmologe. 2015 Feb;112(2):140-7.

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Long Term OutcomesCXL: Long Term Outcomes


c oss g (C ) s a p o s g e apeu cc oss g (C ) s a p o s g e apeu coption to halt the progression of option to halt the progression of keratoconuskeratoconus. . The aim of the study was to prove a longThe aim of the study was to prove a long--term term stabilizing effect of riboflavin and ultravioletstabilizing effect of riboflavin and ultraviolet--A A induced collagen CXL in young and otherwise induced collagen CXL in young and otherwise healthy patients with progressive healthy patients with progressive keratoconuskeratoconusand a corneal thickness of at least 400and a corneal thickness of at least 400 μmμm onaverage 10 years after treatment..

Results: The mean preoperative age was 28 : The mean preoperative age was 28 ±± 7 7 years (range 14years (range 14--42 years), 4 patients were female 42 years), 4 patients were female (7 eyes) and 16 patients (23 eyes) were male. (7 eyes) and 16 patients (23 eyes) were male.

Preoperatively, the mean KPreoperatively, the mean K--value on the apex of value on the apex of k tk t 6262 13 2D hi h h d13 2D hi h h d

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Long Term Outcomes (CXL: Long Term Outcomes (TheuringTheuring et al)et al)


keratoconuskeratoconus was 62 was 62 ±± 13.2D which showed a 13.2D which showed a statistically significant reduction after 10 years to statistically significant reduction after 10 years to 55 55 ±± 8.1 8.1 D (p = 0.001). D (p = 0.001).

The mean KMAX (53 The mean KMAX (53 ±± 8.2 versus 49 8.2 versus 49 ±± 6.6 6.6 D) and D) and KMIN values (48 KMIN values (48 ±± 5.5 vs. 45 5.5 vs. 45 ±± 5.1 5.1 D) also showed D) also showed a statistically significant decrease (a statistically significant decrease (pp = 0.001) = 0.001)

The mean change in corneal thickness at The mean change in corneal thickness at the 10the 10--year follow up was 46year follow up was 46 μmμm((pp = 0.001). Bias possibly occurred = 0.001). Bias possibly occurred because of a change of the measurement because of a change of the measurement method from ultrasound method from ultrasound pachymetrypachymetry to to



p y yp y yoptical optical pachymetrypachymetry with Oculus with Oculus PentacamPentacam®. ®.

Neither corneal endothelium nor deeper Neither corneal endothelium nor deeper structures suffered any damage. structures suffered any damage.

Only two patients had continuous Only two patients had continuous progression of progression of keratoconuskeratoconus and needed a and needed a reapplication of CXL.reapplication of CXL.

Conclusion/Summary: : CXL is a promising CXL is a promising therapeutic option for progressing therapeutic option for progressing keratoconuskeratoconusto obtain longto obtain long--term stabilization. term stabilization.

Th t i d i t f ll KTh t i d i t f ll K



There was a sustained improvement of all KThere was a sustained improvement of all K--values and BCVA 10 years after initial CXL values and BCVA 10 years after initial CXL treatment. treatment.

CXL is minimally invasive and easy to handle. CXL is minimally invasive and easy to handle. Possible side effects, such as endothelial Possible side effects, such as endothelial damage was not observed.damage was not observed.

TransepithelialTransepithelial CXLCXL

High Irradiance CXLHigh Irradiance CXL

Oxygen Enhanced CXLOxygen Enhanced CXL

Accelerated CXL with Pulsed Accelerated CXL with Pulsed

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Future Directions/ApplicationsCXL: Future Directions/Applications


IlluminationIllumination

IntrastromalIntrastromal CXLCXL

LASIK LASIK XtraXtra & PRK & PRK XtraXtra

Topographic Guided Topographic Guided -- CXLCXL

Alternative Agent CXLAlternative Agent CXL

Selective CXLSelective CXL

Accelerated CXLAccelerated CXL•• Original Original CXL studies at CXL studies at Dresden Dresden Technical University in the late 90s Technical University in the late 90s

were conducted with 3mW/cm2 irradiance, requiring were conducted with 3mW/cm2 irradiance, requiring 30 Min UV time30 Min UV time

•• The Bunson Roscoe Law of Reciprocity states that The Bunson Roscoe Law of Reciprocity states that the UV the UV photochemicalphotochemical biologicalbiological effects iseffects is proportional to the total energyproportional to the total energy

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Future Directions/ApplicationsCXL: Future Directions/Applications


photochemical photochemical biological biological effects is effects is proportional to the total energy proportional to the total energy dose delivered, regardless of the applied irradiance and timedose delivered, regardless of the applied irradiance and time

•• The energy delivered by a UV source is the product of the irradiance The energy delivered by a UV source is the product of the irradiance of the light source and the delivery timeof the light source and the delivery time

Irradiance (mW/cm2) x Time (seconds) = Dose (J/cm2)

3 mW/cm2 x 30 Minutes = 30 mW/cm2 x 3 Minutes

Amplification of Amplification of CrossCross--Linking ChemistryLinking Chemistry


Sodium HydrosulfiteSodium HydrosulfiteNaNa22SS22OO4 4 DemoDemo

Name Formulation Procedure Application

VibeX 0.1% Riboflavin20% Dextran

KXL

Keratoconus &

Post-LASIK Ectasia

Epi-Off

KXL

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: CXL: AvedroAvedro Riboflavin FamilyRiboflavin Family


VibeX Rapid 0.1% RiboflavinHPMC

KXL

Keratoconus &

Post-LASIK Ectasia

Epi-Off

ParaCel0.25% Riboflavin

HPMC, BAC

EDTA, TRIS

KXL

Keratoconus &

Post-LASIK Ectasia

Epi-On

VibeX Xtra 0.25% RiboflavinSaline

Lasik Xtra

Corneal Strengthening During LASIK

Stromal Bed

The KXL™ System is not approved for sale in the US. The KXL™ System is not approved for sale in the US.



33) ) Functional Approach Functional Approach –– Stabilization + Ref. CorrectionStabilization + Ref. Correction



Gomes JA, Tan D, Gomes JA, Tan D, RapuanoRapuano CJ, Belin MW, CJ, Belin MW, AmbrósioAmbrósio R Jr, R Jr, GuellGuell JL, JL, MalecazeMalecaze F, Nishida K, F, Nishida K, SangwanSangwan VS; Group of Panelists for the Global Delphi VS; Group of Panelists for the Global Delphi Panel of Panel of KeratoconusKeratoconus and and EctaticEctatic Diseases. Global consensus on Diseases. Global consensus on keratoconuskeratoconus and and ectaticectatic diseases. Cornea. 2015 Apr;34(4):359diseases. Cornea. 2015 Apr;34(4):359--69.69.

TopoTopo--guided guided transepithelialtransepithelial PRK/CXL PRK/CXL PRK ablation facilitates riboflavin penetrationPRK ablation facilitates riboflavin penetration

Minimizes surface healing time and PRK hazeMinimizes surface healing time and PRK haze

Does not Does not remove remove already CXL tissues already CXL tissues

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPRK/CXL ComboPRK/CXL Combo


Statistical Statistical significance found in simultaneous significance found in simultaneous vsvs. . Sequential Sequential group, although group, although TxTx effects seen in effects seen in both groups (198 vs. 127 eyes)both groups (198 vs. 127 eyes)

Better Better BSCVA (p<0.001), reduction in MRSE BSCVA (p<0.001), reduction in MRSE (p<0.005) and reduction in K values (p<0.005) (p<0.005) and reduction in K values (p<0.005)

1. 1. StojanovicStojanovic A, Zhang J, Chen X, A, Zhang J, Chen X, NitterNitter TA, Chen S, Wang Q. TopographyTA, Chen S, Wang Q. Topography--guided guided transepithelialtransepithelial surface ablation followed by surface ablation followed by corneal collagen crosscorneal collagen cross--linking performed in a single combined procedure for the treatment of linking performed in a single combined procedure for the treatment of keratoconuskeratoconus and pellucid and pellucid marginal degeneration. J Refract Surg. 2010 Feb;26(2):145marginal degeneration. J Refract Surg. 2010 Feb;26(2):145--52. 52. 2. 2. KanellopoulosKanellopoulos AJ. Comparison of sequential AJ. Comparison of sequential vsvs samesame--day simultaneous day simultaneous collagencrosscollagencross--linking and topographylinking and topography--guided PRK guided PRK for treatment of for treatment of keratoconuskeratoconus. J Refract Surg. 2009 Sep;25(9):S812. J Refract Surg. 2009 Sep;25(9):S812--8. 8.

Step 1: Step 1: Minimum Minimum ablation strategy ablation strategy ~ 70% ~ 70% of sphere and cylinder,of sphere and cylinder,

OZ OZ ≤ 5.5mm & ablation ≤ 50 ≤ 5.5mm & ablation ≤ 50 µm,µm,

0.02% 0.02% MMC (20 MMC (20 seconds) seconds) and and BSS BSS

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPRK/CXL Combo: PRK/CXL Combo: AthensAthens ProtocolProtocol


irrigation (balance irrigation (balance salt solutionsalt solution))

Step 2: CXLStep 2: CXL

PostPost--Op ManagementOp Management Topical Topical antibiotic/steroid/1000 mg Vitamin antibiotic/steroid/1000 mg Vitamin

C/SunglassesC/Sunglasses

KanellopoulosKanellopoulos AJ, Binder PS. Management of corneal AJ, Binder PS. Management of corneal ectasiaectasia after LASIK after LASIK withcombinedwithcombined, same, same--day, topographyday, topography--guided guided partial partial transepithelialtransepithelial PRK and collagen crossPRK and collagen cross--linking: the linking: the athensathens protocol. J Refract Surg. 2011 May;27(5):323protocol. J Refract Surg. 2011 May;27(5):323--31. 31.

Goal Goal in KC/in KC/EctasiaEctasia is mainly therapeutic is mainly therapeutic

Potential Use in patients at risk for Potential Use in patients at risk for ectasiaectasia

“Touch“Touch--up” after up” after IntacsIntacs

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPRK/CXL Combo: PRK/CXL Combo: AthensAthens ProtocolProtocol

Hersh Vision GroupHersh Vision GroupKanellopoulosKanellopoulos AJ, Binder PS. Management of corneal AJ, Binder PS. Management of corneal ectasiaectasia after LASIK after LASIK withcombinedwithcombined, same, same--day, topographyday, topography--guided guided partial partial transepithelialtransepithelial PRK and collagen crossPRK and collagen cross--linking: the linking: the athensathens protocol. J Refract Surg. 2011 May;27(5):323protocol. J Refract Surg. 2011 May;27(5):323--31. 31.

Pre:Pre:

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPRK/CXL Combo: Biomechanics!PRK/CXL Combo: Biomechanics!


Post:Post:10 months10 months

Courtesy of Renato Courtesy of Renato AmbrosioAmbrosio, MD, PhD, MD, PhD

19841984

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS/ICRS/IntraCornealIntraCorneal Ring SegmentRing Segment

PMMA proves PMMA proves biocompatible biocompatible

KeraRingKeraRing–– MediphacosMediphacos, Brazil, Brazil


Colin J, et al. Correcting Colin J, et al. Correcting keratoconuskeratoconus with with intracornealintracorneal rings. J Cataract Refract rings. J Cataract Refract SurgSurg 2000; 26:11172000; 26:1117––1122. 1122. Miranda D, Sartori M, Francesconi C, et al. Ferrara intrastromal corneal Miranda D, Sartori M, Francesconi C, et al. Ferrara intrastromal corneal ring segments for severe ring segments for severe keratoconuskeratoconus. J Refract Surg. . J Refract Surg. 2003;19:6452003;19:645––653. 653.

Adjustable RingAdjustable Ring19841984

Ferrara RingFerrara Ring–– AJL, SpainAJL, Spain

IntacsIntacs–– Oasis Medical, USAOasis Medical, USA

Barraquer’sBarraquer’s law of thicknesslaw of thickness αα thickness, andthickness, and 1/1/αα diameterdiameter

Potential structural support?Potential structural support?

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS: ICRS: IntacsIntacs®® & Arc Shortening Effect& Arc Shortening Effect


pppp Ablation or Ablation or iincision may further ncision may further

weaken KC corneasweaken KC corneas Stability? (Stability? (BediBedi et al, 2012; 92.9%)et al, 2012; 92.9%)

Flattening central to DeviceFlattening central to Device

MidperipheralMidperipheral to to PeriphealPeripheal SteepeningSteepening

Centripetal apical shiftCentripetal apical shift

IntralaseIntralase laser creates channels & incision sitelaser creates channels & incision site More More reproduciblereproducible

SuturelessSutureless??

More effective?More effective?

Channel DimensionsChannel Dimensions

Better postBetter post--op comfort?op comfort?

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS: New ICRS: New FemtoFemto--Second ApplicationSecond Application


PostPost--IntacsIntacs®®, Day 1, Day 1 PostPost--PKP, 1 weekPKP, 1 week

SK series (Currently not available in US)SK series (Currently not available in US) 400400SK SK :K 57:K 57-- 62D, & 62D, & CylCyl < 5D< 5D

450450SK SK :K > 62D, & :K > 62D, & CylCyl > 5D> 5D–– AlioAlio JL et al (2006): better results with mean K≤ JL et al (2006): better results with mean K≤

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS: New ICRS: New IntacsIntacs®® SK SeriesSK Series


53D!53D!

Courtesy: Josef Ruckhofer, MD Courtesy: Rex Hamilton, MD (UCLA Jules Stein)

Combo Intacs/CX

L 350

Sequential Intacs/CXL

350

Symmetric 450

Intacs/CXL

Assymmetric 210 /450 Intacs/CXL

Single Segment

Mean UCVA (logMAR)

-0.03 -0.26 -0.80 -0.16 -0.19

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS: New ICRS: New IntacsIntacs®® AlgorithmsAlgorithms


Mean BSCVA (logMAR)

-0.05 -0.10 -0.06 0.04 -0.18

Max Flattening

5.84 D 5.34 D 5.85 D 6.59 D 7.23 D

Increased Coupling

101000 offset in offset in femtofemto incisionincision

Move Move IntacsIntacs

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS: New ICRS: New IntacsIntacs®® Incision OffsetIncision Offset


segment from segment from incision siteincision site

WWound gapeound gape

SutureSuture

Despite CL material/design advancementsDespite CL material/design advancements 1212--26% KC patients seek surgical Tx26% KC patients seek surgical Tx11--33

PKP most commonPKP most common

AlternativeAlternative keratorefractivekeratorefractive Treatment OptionsTreatment Options

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS: PostICRS: Post--Op GoalsOp Goals


Alternative Alternative keratorefractivekeratorefractive Treatment OptionsTreatment Options Ablative, Ablative, IncisionalIncisional, Thermal, Additive, Thermal, Additive

LewingerLewinger S et alS et al44: BCVA unchanged : BCVA unchanged spspIntacsIntacs®®, but , but mean UCVA improved from 20/200 to mean UCVA improved from 20/200 to 20/50 (N=58 eyes)20/50 (N=58 eyes)

–– 72.2% reported significant VA improvement72.2% reported significant VA improvement

1. Crews MJ et al. The Clinical Management of Keratoconus: A 6 Year Retrospective Study. CLAO J 1994;20(3):194-7.2. Gordon MO et al. Baseline Factors Predictive of Incident of Penetrating Keratoplasty in Keratoconus. Am J Ophthalmol 2006;142(6):923-303. Betts AM et al. Visual Performance and Comfort with the Rose K Lens for Keratoconus (CLEK) Study. Optom Vis Sci 2002;79(8):493-5014. Levinger S and Pokroy R. KC managed with Intacs One Year Results. Arch Ophthalmol 2005;123:1308-1314.

KC OU; Dual KC OU; Dual IntacsIntacs® in OD, 7 ® in OD, 7 yrsyrs

UCVA UCVA 20/200 20/200

MR: MR: --2.00, 2.00, --4.00 x105 4.00 x105 20/2520/25--

Poor SCL VA with KC progression & Poor SCL VA with KC progression & Intolerant to Intolerant to DuetteDuette hybridshybrids

1Mth, Post1Mth, Post--IntacsIntacs® exchange® exchange

UCVA UCVA 20/20020/200

MRMR: : --4.254.25, , --1.25 x095 1.25 x095 20/2520/25+ +

Pt Ed. on Pt Ed. on specialty specialty CLs but CLs but happy happy with DW soft with DW soft toricstorics

KC OU; Dual KC OU; Dual IntacsIntacs® in OD, 7 ® in OD, 7 yrsyrs

UCVA UCVA 20/200 20/200

MR: MR: --2.00, 2.00, --4.00 4.00 x105 x105 20/2520/25--

Poor SCL VA with KC progression & Poor SCL VA with KC progression & Intolerant to Intolerant to DuetteDuette hybridshybrids

1Mth, Post1Mth, Post--IntacsIntacs® exchange® exchange

UCVA UCVA 20/20020/200

MRMR: : --4.254.25, , --1.25 1.25 x095 x095 20/2520/25++

Pt Ed. on Pt Ed. on specialty specialty CLs but CLs but happy happy with DW soft with DW soft toricstorics



1 Month Pre-Op

Primary GoalsPrimary Goals ReRe--EvaluateEvaluate contact lens options and goalscontact lens options and goals DeferDefer immediate need for immediate need for keratoplastykeratoplasty

Secondary GoalsSecondary Goals



Secondary GoalsSecondary Goals ReduceReduce anisokoniaanisokonia Potentially Potentially improveimprove visual functionsvisual functions

Ibrahim TA (2006; N=186 eyes; 5 Ibrahim TA (2006; N=186 eyes; 5 YrsYrs))–– UCVA & BCVA improved in 85.23% & 87.9%UCVA & BCVA improved in 85.23% & 87.9%–– BCVA gain of > 3 lines in 19.7%BCVA gain of > 3 lines in 19.7%–– BCVA gain between 1BCVA gain between 1--3 lines in 68.2%3 lines in 68.2%

PrePre OpOp::

DefDef. . AmplAmpl.: .: 1,35 mm1,35 mm

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS: Biomechanics!ICRS: Biomechanics!


Post Post OpOp::

DefDef. . AmplAmpl.: .: 1,15 mm1,15 mm

Initial approval Initial approval to to TTxx low to moderate hyperopia low to moderate hyperopia (+0.75D (+0.75D to to +3.00D +3.00D with < with < --0.75D 0.75D cylindercylinder))

FDA FDA panel approval for “Near Vision” CKpanel approval for “Near Vision” CK

Other Other offoff--label applications label applications

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCK/Conductive CK/Conductive KeratoplastyKeratoplasty


pppp Regular Regular and irregular and irregular CylCyl (Post(Post--surgical and KCsurgical and KC))

Tissue resistance to current flow Tissue resistance to current flow Radiofrequency Radiofrequency via via a 450 x 90 micron probe a 450 x 90 micron probe

Self regulated and homogenous thermal profileSelf regulated and homogenous thermal profile

656500C to 75C to 7500CC

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCK/Conductive CK/Conductive KeratoplastyKeratoplasty


6565 C to 75C to 75 CC

Denatures/Shrinks Denatures/Shrinks conrealconreal collagecollage

Radial Radial Stress/TensionStress/TensionStress/Tension Stress/Tension

LinesLines

Photo courtesy of Roy Photo courtesy of Roy RubinfeldRubinfeld, MD, MD

Stabilize and enhance Stabilize and enhance surface symmetrysurface symmetry CXL CXL stabilizes KC and may stabilizes KC and may retain retain other other TxTx effectseffects

IntacsIntacs®® flatten and more centrally shift cone apex flatten and more centrally shift cone apex

CK further decreases residual CK further decreases residual CylCyl

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCK/CK/IntacsIntacs®®/CXL Combo/CXL Combo




33) ) Functional Approach Functional Approach –– Stabilization + Ref. CorrectionStabilization + Ref. Correction



Superficial keratectomy Superficial keratectomy (SK) (SK)

±± Phototherapeutic Phototherapeutic keratectomy (PTK) keratectomy (PTK)

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesSK/PTK: Old Fashioned But Not Gone!SK/PTK: Old Fashioned But Not Gone!


Treatment of KC apical Treatment of KC apical nodulesnodules

Improve Improve surface optical surface optical characteristicscharacteristics

Improve contact lens Improve contact lens tolerancetolerance

Hersh Vision GroupHersh Vision GroupGomes JA, Tan D, Gomes JA, Tan D, RapuanoRapuano CJ, Belin MW, CJ, Belin MW, AmbrósioAmbrósio R Jr, R Jr, GuellGuell JL, JL, MalecazeMalecaze F, Nishida K, F, Nishida K, SangwanSangwan VS; Group of Panelists for the Global Delphi VS; Group of Panelists for the Global Delphi Panel of Panel of KeratoconusKeratoconus and and EctaticEctatic Diseases. Global consensus on Diseases. Global consensus on keratoconuskeratoconus and and ectaticectatic diseases. Cornea. 2015 Apr;34(4):359diseases. Cornea. 2015 Apr;34(4):359--69.69.

Unsatisfactory/NonUnsatisfactory/Non--functional vision functional vision Specialty CL DevicesSpecialty CL Devices

Advanced central ScarringAdvanced central Scarring

CL “Intolerant” CL “Intolerant”

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesKeratoplastyKeratoplasty: Timing for Referral/Consult: Timing for Referral/Consult

Spectacles Rx in CL “intolerant” Pts Spectacles Rx in CL “intolerant” Pts

Recurrent Recurrent hydropshydrops

“Dangerously” thin cornea?“Dangerously” thin cornea?

http://www.aocle.org/livingL/images/hydrop1.jpg

With PKP, there is still the With PKP, there is still the considerable risk of considerable risk of endothelial endothelial rejectionrejection::

Thi Ri k i “F ”Thi Ri k i “F ”

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesKeratoplastyKeratoplasty: Lamellar Vs PKP Techniques: Lamellar Vs PKP Techniques


This Risk is “Forever”This Risk is “Forever”

Lamellar techniques may be beneficial Lamellar techniques may be beneficial for KC patients who are typically younger for KC patients who are typically younger and would otherwise have lifelong risk of and would otherwise have lifelong risk of rejectionrejection

.cha

dros

tron

.co.

uk.c

hadr

ostr

on.c

o.uk

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesKeratoplastyKeratoplasty: DALK: DALK


ww

w.

ww

w.

PKP carries lifelong risk of endothelial rejection, PKP carries lifelong risk of endothelial rejection, so MDALK may benefit younger KC patients so MDALK may benefit younger KC patients who has higher accumulative riskwho has higher accumulative risk

Technically more difficult, longer surgeryTechnically more difficult, longer surgeryUp to 25% of cases req ireUp to 25% of cases req ire PKP con ersionPKP con ersion

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesKeratoplastyKeratoplasty: DALK: DALK


Up to 25% of cases require Up to 25% of cases require PKP conversionPKP conversion EEndothelial protection over PKP still debated ndothelial protection over PKP still debated

www.keratokonuswww.keratokonus--center.decenter.de

Perfect centration is critical Perfect centration is critical to minimize torsional to minimize torsional CCylyl and and HOAHOA

Donor/Host alignmentDonor/Host alignment

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesPKP: Intraoperative ChallengesPKP: Intraoperative Challenges


Classic Classic vertical vertical punch punch requires requires tight tight sutures sutures to to withstand IOP withstand IOP

Up to 4% wound Up to 4% wound dehiscence after removal dehiscence after removal

Tight and nonTight and non--uniform sutures result in regular uniform sutures result in regular and irregular postand irregular post--operative operative CCylyl

Typically ≥ 5D at 3 Typically ≥ 5D at 3 MthsMths, may reduce to ≤ 3.5D, may reduce to ≤ 3.5D11

–– selective selective suture removal suture removal (if interrupted sutures) (if interrupted sutures) –– SSuture adjustment uture adjustment (single running suture) (single running suture)

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesPKP: Intraoperative ChallengesPKP: Intraoperative Challenges


jj ( g g )( g g )

Stable Stable VA generally at 12VA generally at 12--24 24 MthsMths22

BCVA ≥ 20/40 in 73.2% BCVA ≥ 20/40 in 73.2% with low rate of recurrent KCwith low rate of recurrent KC–– 20/50 at 6 Months20/50 at 6 Months–– 20/40 at 1 Year20/40 at 1 Year–– 20/20 at 2 Years20/20 at 2 Years

1.1. KarabatsasKarabatsas CH, Cook SD, CH, Cook SD, FigueiredoFigueiredo FC, Diamond JP, FC, Diamond JP, EastyEasty DL. Combined interrupted and continuous versus single DL. Combined interrupted and continuous versus single continuous adjustable suturing in penetrating continuous adjustable suturing in penetrating keratoplastykeratoplasty: a prospective, randomized study of induced astigmatism during : a prospective, randomized study of induced astigmatism during the first postoperative year. Ophthalmology. 1998 Nov;105(11):1991the first postoperative year. Ophthalmology. 1998 Nov;105(11):1991--88..

2.2. PramanikPramanik S, S, MuschMusch DC, DC, SutphinSutphin JE, JE, FarjoFarjo AA. Extended longAA. Extended long--term outcomes of penetrating term outcomes of penetrating keratoplastykeratoplasty for for keratoconuskeratoconus. . Ophthalmology. 2006 Sep;113(9):1633Ophthalmology. 2006 Sep;113(9):1633--8.8.

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesIEK / IEK / IntralaseIntralase Enabled Enabled KeratoplastyKeratoplasty


Theoretical advantagesTheoretical advantages BladelessBladeless

Higher precisionHigher precision

RReduced educed technical difficultytechnical difficulty

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesIEK: New Frontier with Shaped GraftsIEK: New Frontier with Shaped Grafts


Potentially increasing wound stability Potentially increasing wound stability and decreasing postand decreasing post--operative operative CylCyl

Ability to perform shaped transplantsAbility to perform shaped transplants

Better wound structureBetter wound structure

Less suture tension = less induced Less suture tension = less induced cylcyl

Early suture removal for faster visual recovery courseEarly suture removal for faster visual recovery course

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesIEK: New Frontier with Shaped GraftsIEK: New Frontier with Shaped Grafts


SutureSutureNot TightNot Tight

Intraocular PressureIntraocular Pressure

Prevents LeakagePrevents Leakage

Hersh Vision GroupHersh Vision GroupGomes JA, Tan D, Gomes JA, Tan D, RapuanoRapuano CJ, Belin MW, CJ, Belin MW, AmbrósioAmbrósio R Jr, R Jr, GuellGuell JL, JL, MalecazeMalecaze F, Nishida K, F, Nishida K, SangwanSangwan VS; Group of Panelists for the Global Delphi VS; Group of Panelists for the Global Delphi Panel of Panel of KeratoconusKeratoconus and and EctaticEctatic Diseases. Global consensus on Diseases. Global consensus on keratoconuskeratoconus and and ectaticectatic diseases. Cornea. 2015 Apr;34(4):359diseases. Cornea. 2015 Apr;34(4):359--69.69.

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPrePre-- and Postand Post--Op Optical RehabilitationOp Optical Rehabilitation

RGPRGP

HybridHybrid ScleralScleral

Soft KC Soft KC

Recessed CL SystemRecessed CL System

PiggybackPiggyback

PostPost--KP CL designs choices depends on KP CL designs choices depends on Patient lens wear historyPatient lens wear history

Corneal topography Corneal topography –– various possible profilesvarious possible profiles

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesPostPost--KP CLF: ChallengesKP CLF: Challenges

Cutler in Hom, Manual of Contact Lens Prescribing and Fitting

Reduced VA from Reduced VA from irregular surfaceirregular surface

66 12 th t12 th t

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesPostPost--KP CLF: TimingKP CLF: Timing

66--12 months post 12 months post surgerysurgery

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPostPost--ICRS CLF: ChallengesICRS CLF: Challenges


Nepomuceno RL,Nepomuceno RL, Boxer Boxer WachlerWachler BS, BS, WeissmanWeissman BA. BA. Feasibility of Contact Lens Fitting on Feasibility of Contact Lens Fitting on KeratoconusKeratoconus Patients with INTACS InsertsPatients with INTACS Inserts. . ContCont Lens Anterior Eye. 2003 Dec;26(4):175Lens Anterior Eye. 2003 Dec;26(4):175--80.80.

Segment bearing/binding Reduced Tear Exchange

Keratitis/erosion Hypoxia

Greatest flattening effects over segmentsGreatest flattening effects over segments77--99

ICRS creates ICRS creates midperipheralmidperipheral zone(s) of elevationzone(s) of elevation Old: Apical bearing/Old: Apical bearing/DecentrationDecentration/Edge lift /Edge lift

New: New: MidperipheralMidperipheral bearing? Better Centration & edge lift?bearing? Better Centration & edge lift?



7. Smith KA et al. High-DK Piggyback Contact Lenses Over Intacs for Keratoconus: a Case Report. Eye Contact Lens 2008;34(4):238-41.8. Ucakhan OO et al. Contact Lens Fitting for Keratoconus after Intacs Placement. Eye Contact Lens 2006;32(2):75-7.9. Nepomuceno RL et al. Feasibility of Contact Lens Fitting on Keratoconus Patients with Intacs Inserts. Cont Lens Ant Eye 2003;26(4):175-80.

7.0mm Optical Zone7.0mm Optical Zone

6.0mm Optical Zone6.0mm Optical Zone



pp

IntacsIntacs®® Ferrara RingFerrara Ring

Implantation StrategiesImplantation Strategies DepthDepth

Number of Segment(s)Number of Segment(s)

ICRS DesignsICRS Designs

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPostPost--ICRS CLF: ConsiderationsICRS CLF: Considerations


Location of Elevation (Location of Elevation (ieie, OZ), OZ)

Magnitude of Elevation (Magnitude of Elevation (ieie, , IntacsIntacs®® SK)SK)

PostPost--Op MR & VA Op MR & VA Stabilization Stabilization ((IntacsIntacs®® Vs. CXL VsVs. CXL Vs. . CXL/CXL/IntacsIntacs®® ))

PrePre--op op Expectations Expectations ManagementManagement PrePre--Op CL historyOp CL history

PostPost--Op MR & VA Op MR & VA Stabilization (Stabilization (IntacsIntacs®® Vs. CXL Vs. CXL/Vs. CXL Vs. CXL/IntacsIntacs®® ))

PrePre--op Expectations Managementop Expectations Management PrePre--Op CL historyOp CL history

AlioAlio JL et alJL et al11: 3 : 3 mthsmths stabilization stabilization May take up to 12 May take up to 12 mthsmths for advanced KCfor advanced KC

PostPost--ICRS fitting can defer PK in severe KCICRS fitting can defer PK in severe KC22

–– UcakhanUcakhan O et al 2006O et al 2006 PreopPreop

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPostPost--ICRS CLF: TimingICRS CLF: Timing


–– UcakhanUcakhan O et al, 2006O et al, 2006

PostPost--ICRS Fitting GoalsICRS Fitting Goals PrePre--Op goals and CL Op goals and CL HxHx

–– Patient interview & educationPatient interview & education

–– BCLVA, tolerance, I & RBCLVA, tolerance, I & R

Minimize excess Minimize excess pressure on ICRSpressure on ICRS

PreopPreop

DeDe--epiepi

ReRe--epiepi

RemodelRemodel

1. Alio J, Artola A, Hassanein A, et al. One or 2 Intacs Seg for the correction of KC. J Cat Refract Surg 2005;31:943-53 2. Ucakhan OO et al. Contact Lens Fitting for Keratoconus after Intacs Placement. Eye Contact Lens 2006;32(2):75-7.

““Satisfactory” PostSatisfactory” Post--Op Op BSVA (mild HOA BSVA (mild HOA SxSx))Enhanced CT profile: Gradient CT controlEnhanced CT profile: Gradient CT control

Large OZ: Sag depth to better drape entire cornea,Large OZ: Sag depth to better drape entire cornea,

Independent Curvature System: BC and FCIndependent Curvature System: BC and FC

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPostPost--ICRS CLF: Soft KC CLsICRS CLF: Soft KC CLs


Wide Rx Range: High Wide Rx Range: High SphSph and and CylCyl RxRx

Pending ICRS nomogram usedPending ICRS nomogram used

Modern larger diameter GP & multiple PC zonesModern larger diameter GP & multiple PC zones Enhanced Sag depth/BOZD Enhanced Sag depth/BOZD

QuadrantQuadrant--specific & Reverse Geo. designs specific & Reverse Geo. designs

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesPostPost--ICRS CLF: Corneal GPsICRS CLF: Corneal GPs


Modify PC systems to aid tear dynamics Modify PC systems to aid tear dynamics

BastosBastos L. L. Fitting Fitting KeratoconusKeratoconus After After intracornealintracorneal Ring Ring Implants. Implants. ContactContact LensLens Spectrum 2011;11:40Spectrum 2011;11:40--22

If can not achieve alignment with ICRS, then If can not achieve alignment with ICRS, then minimize positive pressure over minimize positive pressure over SSegment by egment by

High DK disposable softHigh DK disposable soft High DK custom softHigh DK custom soft

Subjective comfortSubjective comfort

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesPostPost--ICRS CLF: Piggyback CLsICRS CLF: Piggyback CLs


–– Subjective comfortSubjective comfort–– Lens CentrationLens Centration–– Tear ExchangeTear Exchange–– Ocular surface healthOcular surface health–– Improve CLVA?Improve CLVA?

Reverse Geometry with 6.5mm OZReverse Geometry with 6.5mm OZ New SK series (400/450): 6mm OZNew SK series (400/450): 6mm OZ

–– Limited vaulting?Limited vaulting?

NonNon--SK series: 7mm OZSK series: 7mm OZ

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesPostPost--ICRS CLF: Hybrid CLsICRS CLF: Hybrid CLs


–– Alignment with soft skirt?Alignment with soft skirt?

Hyper Hyper dKdK generations generations reduces hypoxia reduces hypoxia concernsconcerns

GP: GP: DkDk 130130

Soft Skirt: 84Soft Skirt: 84

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPostPost--ICRS CLF: Hybrid CLsICRS CLF: Hybrid CLs


Courtesy of J Courtesy of J SonsinoSonsino O.D.O.D.

Minimally sustainable vault over cornea + Minimally sustainable vault over cornea + limbuslimbus Scleral/Scleral/ConjConj alignment & weight distributionalignment & weight distribution

Liquid bandage protects ICRS segment(s) and improves VALiquid bandage protects ICRS segment(s) and improves VA Therapeutic propertiesTherapeutic properties

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPostPost--ICRS CLF: ScleralICRS CLF: Scleral--GPsGPs


Courtesy of Dr. Shelley Cutler

NonNon--SurgicalSurgical SurgicalSurgicalSuccess Rate 94 2% 97 3%

Chang C, Shin A, & Chang C, Shin A, & HershHersh P P : : Presented Presented findings of 329 findings of 329 eyes at ASCRS/GSLS 2012 eyes at ASCRS/GSLS 2012 (Data (Data to be published).to be published).

Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesCLEI CLF Study: OutcomeCLEI CLF Study: Outcome


94.2% 97.3%

Habitual VA 20/60.5 20/57.7

Final CLVA 20/27.9 20/28.7

Tolerance at Presentation

63.4%* 38.2%*

Tolerance after Fitting

95.8% 98.5%

Chang C, Shin A, & Chang C, Shin A, & HershHersh PP: Retrospective : Retrospective review of consecutive postreview of consecutive post--operative cases operative cases (Data to be published).(Data to be published).

Overall Success Rate = 97.7% (84/86)Overall Success Rate = 97.7% (84/86)

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCLEI PostCLEI Post--ICRS CLF Study: OutcomeICRS CLF Study: Outcome


Surgery TypeSurgery Type N = 86N = 86 SuccessSuccess

Collagen Collagen CrosslinkingCrosslinking (CXL)(CXL) 41 95.1% (39/41)

CXL & CXL & IntacsIntacs 33 100% (33/33)

PKPPKP 12 100% (12/12)

s/p CXLs/p CXL--IntacsIntacs

CL Tolerance at CL Tolerance at PresentationPresentation

48.1%*



PostPost--CXL/CXL/IntacsIntacs CLF CLF SuccessSuccess

100% (33/33)

LogMARLogMAR Habitual VAHabitual VA 0.44 (20/55.6)

LogMARLogMAR Final CLVA Final CLVA 0.17 (20/29.6)

*Tolerance is defined as patients who present with CLs on eyes regardless of functional *Tolerance is defined as patients who present with CLs on eyes regardless of functional wear timewear time

80.0%80.0%77.8%77.8%

50 0%50 0%

90.9%90.9%

75%75%



50.0%50.0%

Expanding KC management paradigmExpanding KC management paradigm Specialty contact lens devicesSpecialty contact lens devices, including corneal, including corneal--GPs, GPs,

continue to be effective visual rehabilitation toolscontinue to be effective visual rehabilitation tools

Early detection and stabilization Early detection and stabilization optimizes patient outcome optimizes patient outcome and preserve PKP as future option if need arisesand preserve PKP as future option if need arises

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesConclusionConclusion


Interdisciplinary CoInterdisciplinary Co--management approach essentialmanagement approach essential PostPost--operative use of specialty contact lens operative use of specialty contact lens devices may devices may

augment surgical benefitsaugment surgical benefits

New ICRS nomograms followed by modern CL New ICRS nomograms followed by modern CL designsdesigns11

Discussions Discussions of Postof Post--OP OP expectations, timeline expectations, timeline and goals!and goals! 1, 21, 2

1. Ucakhan OO et al. Contact Lens Fitting for Keratoconus after Intacs Placement. Eye Contact Lens 2006;32(2):75-7.2. Alio J, Artola A, Hassanein A, et al. One or 2 Intacs Seg for the correction of KC. J Cat Refract Surg 2005;31:943-53.

MMaximizing aximizing patient outcome patient outcome & standard & standard of care of care Regional/Local CoRegional/Local Co--Management Network!!Management Network!! International KC Academy of Eye Care International KC Academy of Eye Care Professionals Professionals

(([email protected]@keratoconusacadey.com))

Optometric Optometric Council On Refractive Technology Council On Refractive Technology (( tt ))

Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesConclusion: Use Your Resources!! Conclusion: Use Your Resources!!


((www.ocrt.orgwww.ocrt.org))

Optometric Optometric Cross Cross Linking Linking Society Society ((https://www.facebook.com/Ocxlshttps://www.facebook.com/Ocxls))

National National KC Foundation (KC Foundation (www.nkcf.orgwww.nkcf.org))

GP Lens Institute (GP Lens Institute (www.gpli.infowww.gpli.info))

AAO AAO ((www.aao.orgwww.aao.org))

AAOptAAOpt ((www.aaopt.orgwww.aaopt.org))

ARVO ARVO ((www.arvo.orgwww.arvo.org))

THANK YOUTHANK YOU


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