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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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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.
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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
Hersh Vision GroupHersh Vision Group
–– 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
Hersh Vision GroupHersh Vision Group
BiomechanicalBiomechanical IrregularIrregular
WeakeningWeakening Optics Optics ProgressionProgression
══┼┼
Retarded
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesChallenges In Conventional Challenges In Conventional MxMx: Refractive: Refractive
Hersh Vision GroupHersh Vision Group
┼┼
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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Lower SpecificityLower Specificityifif SolelySolely UsingUsing
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesTopography: Hotspot Recognition!Topography: Hotspot Recognition!
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
–– 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
OD
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Hersh Vision GroupHersh Vision Group
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Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPachymetryPachymetry/Tomography/Tomography
Hersh Vision GroupHersh Vision Group
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Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPachymetryPachymetry/Tomography/Tomography
Hersh Vision GroupHersh Vision Group
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Dynamic Bidirectional Dynamic Bidirectional ApplanationApplanation
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCorneal BiomechanicsCorneal Biomechanics
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
( 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
Hersh Vision GroupHersh Vision Group
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
1) Patient Monitoring Approach 1) Patient Monitoring Approach –– Refractive CorrectionRefractive Correction
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
Gregory Gregory WollensakWollensak
Page 5
908070605040
UV-irradiationwith riboflavin
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Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Riboflavin Absorption SpectrumCXL: Riboflavin Absorption Spectrum
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
AvedroAvedro -- USAUSA
CXLUSA CXLUSA -- USAUSA
PeshkePeshke
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Different DevicesCXL: Different Devices
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
**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:
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Outcomes and indicationsCXL: Outcomes and indications
Hersh Vision GroupHersh Vision Group
KeratoconusKeratoconus Pellucid Marginal DegenerationPellucid Marginal Degeneration PostPost--Refractive Surgery ectasiaRefractive Surgery ectasia Corneal meltingCorneal melting Infectious keratitisInfectious keratitis
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Riboflavin/UVARiboflavin/UVA
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Outcomes and indicationsCXL: Outcomes and indications
Hersh Vision GroupHersh Vision Group
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
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Outcomes and indicationsCXL: Outcomes and indications
Hersh Vision GroupHersh Vision Group
UNEVEN RIBO UNEVEN RIBO DISTRIBUTIONDISTRIBUTION CXL WITH CKCXL WITH CK
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Outcomes and indicationsCXL: Outcomes and indications
Hersh Vision GroupHersh Vision Group
CXL Outcome in the US:CXL Outcome in the US:A Single Center ReviewA Single Center Review
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
p yp y
CXL effect is temporaryCXL effect is temporary
CXL not approved because it’s dangerousCXL not approved because it’s dangerous
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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
Hersh Vision GroupHersh Vision Group
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
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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
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Possible Complications/ConcernsCXL: Possible Complications/Concerns
Hersh Vision GroupHersh Vision Group
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
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Possible Complications/ConcernsCXL: Possible Complications/Concerns
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: EpiCXL: Epi--Off Vs EpiOff Vs Epi--On DebateOn Debate
&&
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
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: EpiCXL: Epi--Off Vs EpiOff Vs Epi--On DebateOn Debate
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
Page 8
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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)
Hersh Vision GroupHersh Vision Group
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
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Long Term Outcomes (CXL: Long Term Outcomes (TheuringTheuring et al)et al)
Hersh Vision GroupHersh Vision Group
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
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCXL: Long Term Outcomes (CXL: Long Term Outcomes (TheuringTheuring et al)et al)
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
IlluminationIllumination
IntrastromalIntrastromal CXLCXL
LASIK LASIK XtraXtra & PRK & PRK XtraXtra
Topographic Guided Topographic Guided -- CXLCXL
Alternative Agent CXLAlternative Agent CXL
Selective CXLSelective CXL
Page 9
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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.
1) Patient Monitoring Approach 1) Patient Monitoring Approach –– Refractive CorrectionRefractive Correction
2) Prophylaxis Approach 2) Prophylaxis Approach –– StabilizationStabilization
33) ) Functional Approach Functional Approach –– Stabilization + Ref. CorrectionStabilization + Ref. Correction
Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesExpanding Expanding Management ParadigmManagement Paradigm
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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.
Page 10
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
Hersh Vision GroupHersh Vision Group
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!
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
PostPost--IntacsIntacs®®, Day 1, Day 1 PostPost--PKP, 1 weekPKP, 1 week
Page 11
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS: PostICRS: Post--Op GoalsOp Goals
Hersh Vision GroupHersh Vision Group
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
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS: PostICRS: Post--Op GoalsOp Goals
Hersh Vision GroupHersh Vision Group
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%
Page 12
PrePre OpOp::
DefDef. . AmplAmpl.: .: 1,35 mm1,35 mm
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesICRS: Biomechanics!ICRS: Biomechanics!
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
1) Patient Monitoring Approach 1) Patient Monitoring Approach –– Refractive CorrectionRefractive Correction
2) Prophylaxis Approach 2) Prophylaxis Approach –– StabilizationStabilization
33) ) Functional Approach Functional Approach –– Stabilization + Ref. CorrectionStabilization + Ref. Correction
Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesExpanding Expanding Management ParadigmManagement Paradigm
Hersh Vision GroupHersh Vision Group
Page 13
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!
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Page 14
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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.
Page 15
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
Hersh Vision GroupHersh Vision Group
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?
Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPostPost--ICRS CLF: ChallengesICRS CLF: Challenges
Hersh Vision GroupHersh Vision Group
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
Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPostPost--ICRS CLF: ChallengesICRS CLF: Challenges
Hersh Vision GroupHersh Vision Group
pp
IntacsIntacs®® Ferrara RingFerrara Ring
Page 16
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
–– 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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
–– 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
Hersh Vision GroupHersh Vision Group
–– 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
Page 17
Advanced KC Treatment StrategiesAdvanced KC Treatment StrategiesPostPost--ICRS CLF: Hybrid CLsICRS CLF: Hybrid CLs
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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
Hersh Vision GroupHersh Vision Group
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%*
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCLEI PostCLEI Post--ICRS CLF Study: OutcomeICRS CLF Study: Outcome
Hersh Vision GroupHersh Vision Group
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%
Advanced Advanced KC Treatment StrategiesKC Treatment StrategiesCLEI PostCLEI Post--ICRS CLF Study: OutcomeICRS CLF Study: Outcome
Hersh Vision GroupHersh Vision Group
50.0%50.0%
Page 18
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
Hersh Vision GroupHersh Vision Group
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!!
Hersh Vision GroupHersh Vision Group
((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
Hersh Vision GroupHersh Vision Group