Page 1. Advanced Keratoconus Treatments Not Just Contact Lenses Anymore. Cornea & Laser Eye Institute- Hersh Vision Group Center for Keratoconus

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1 Cornea & Laser Eye Institute- Center for Keratoconus Advanced Keratoconus Treatments Not Just Contact Lenses Anymore Clark Y. Chang, O.D., MSc, FAAO Director, Contact Lens Service Center for Keratoconus Cornea & Laser Eye Institute Teaneck, NJ Andrew Morgenstern, O.D., FAAO Optometric Subject Matter Expert BAH Contract Support: Vision Center of Excellence Walter Reed NMMC Bethesda, MD Disclosures Clark Y Chang, OD, MSc, FAAO Allergan Oasis Medical Inc. SynergEyes Inc. Special Thanks: Peter S. Hersh, M.D. Medical Monitor, Avedro Inc. Disclosures Andrew Morgenstern, OD FAAO Alcon Allergan Glaukos Oasis Ocusoft Oculus TLC Vision Expo East/West Classic Manifestations Progressive apical thinning with inferior conical protrusion Non-vascularized? Non on-inflammatory? Bilateral but Asymmetric True Unilateral KC? Irregular Cylinder & HOA Vertical Coma Spherical Aberrations Classic Manifestations Onset ~ 1 st -2 nd decade of life and slows down ~ 4 th decade Stabilization trend absolute Incidence 1/2000? Multifactorial causes Genetic? Trauma? IOP? LVC implications? FFKC Topo WNL but Family Hx Rabinowitz et. al Topo Pattern RSB (Stromal Bed) WNL/SBT ABT Inferior Steepening/ SRA 300µm µm µm µm Age CT 510µm µm µm Abnormal ie, FFKC < 240µm < 450µm MRSE -8D 10D -12D 14D > 14D 1. Randleman JB, Trattler WB, Stulting RD. Validation of the Ectasia Risk Score System for preoperative laser in situ keratomileusis screening. Am J Ophthalmol May;145(5): Page 1

2 Multifactorial Etiologies Mechanical trauma in predisposed individuals IOP Spikes Increased surface temperature Inflammatory mediators IL-1/IL-6, MMPs, TNF-α Proteolytic enzymes Contact lens trauma? Sleeping posture? keratocyte apoptosis Reduced biomechanics! Challenges In Conventional Mx Traditional Challenges in KC Mx Biomechanical i Irregular Weakening Optics Progression Challenges In Conventional Mx: Refractive Retarded Advanced Aberrated Wavefront Marsack, JD Increased HOA (5.5x vs. control) vertical coma, trefoil, tetrafoil, and 2 0 astigmatism 1,2 1. Pantanelli S et al. Characterizing the wavefront aberration with keratoconus or penetrating keratoplasty using a high-dynamic range of wavefront sensor. Ophthalmology. 2007;114: Kosaki R et al. Magnitude and orientation of zernike terms in patients with Keratoconus. Invest Ophthalmol Vis Sci. 2007;48: Challenges In Conventional Mx: QOL Growing Accumulations of Stress and 12.9 hrs/wk when absenteeism and presenteeism reviewed Development in working of PITA Americans Syndrome with low Due visionto: 1 Corneal diseases Visual ranked Frustration 5 th major eye diseases Physical Frustration Indirect health care cost estimated at $2.14 billion for Medicare Psychological beneficiaries in Frustration Misperceived as small public health impact Early Detection & Interdisciplinary Co-Management CLEK Are Keys Study to (73) Optimizing vs. AMD 3 Patient (90) vs. Outcome!! AMD 4 (71) 1. Jacobson G, Frick K, Massof R. Impact of Low Vision and Chronic Ophthalmic Conditions on Absenteeism and Lost Work Productivity 2005;22:abstract no Available at (accessed on 12/02/2011) 11) 2. Javitt JC, Zhou Z, Willke RJ. Association Between Vision Loss and Higher Medical Care Cost in Medicare Beneficiaries. Ophthalmology 2007;114: Expanding Management Paradigm 1) Patient Monitoring Approach Refractive Correction 2) Prophylaxis Approach Stabilization ± progression & age 3) Functional Approach Stabilization + Ref. Correction Anatomical/Optical Signs: Examples Munson s Sign/Rizzuti s sign Fleischer Ring/Hydrops/Corneal scar Scissor Reflex/Oil droplet Reflex Warped Mires on keratometry/photokeratoscopy Page 2

3 Topography: Hotspot Recognition! Lower Specificity if Solely Using Color Pattern Recognition Via S/P Decentered Anterior Corneal SunRise LTK Topographical Profiles HSV Corneal Scar Emerging KC Video Courtesy Mike Tullo Pachymetry/Tomography Ultrasound Pachymetry (5262 Eyes) Avg. CT = 544 ±34 um Suspect if < 476 um CCT is Least reliable indicator Global l Delphi Panel KC with normal CCT Optical Pachymetry CT Distribution and Elevation Epithelial masking of anterior curvatures Color Pattern Recognitions!! Posterior Profiles and HOAs (ie ie, V. Coma) Pachymetry/Tomography OD, FAAO Image Courtesy of Barry Eiden, Pachymetry/Tomography Pachymetry/Tomography Image Courtesy of Barry Eiden, OD, FAAO Image Courtesy of Barry Eiden, O OD, FAAO Page 3

4 Corneal Biomechanics Dynamic Bidirectional Applanation Corneal Biomechanics Dynamic Bidirectional Applanation Normal Thin cornea Image Courtesy of Renato Ambrosio, MD, PhD Keratoconus Wavefront Aberrometry High Frequency Ultrasound: Artemis Zernike Chart Podium Presentations 1st ( 1, -1) ( 1, 1) 2nd ( 2, -2) ( 2, 0) ( 2, 2) 3rd ( 3, -3) ( 3, -1) ( 3, 1) ( 3, 3) 4th ( 4, -4) ( 4, -2) ( 4, 0) ( 4, 2) ( 4, 4) Higher order aberrations make up approximately 17% of the total aberrations of normal eyes Reinstein DZ, Archer TJ, Gobbe M, Silverman RH, Coleman DJ. Epithelial thickness in normal Cornea: three dimensional display with Artemis very high frequency digital ultrasound.. J Refract Surg 2008;24: Expanding Management Paradigm 1) Patient Monitoring Approach Refractive Correction 2) Prophylaxis Approach Stabilization 3) Functional Approach Stabilization + Ref. Correction CXL/Corneal Cross-linking UV + Riboflavin (vitamin B2): 1 st reported at U of Dresden; many other studies ongoing since 1994 Theo Seiler Eberhard Spoerl Gregory Wollensak Page 4

5 n Stiffness ( %) Increase in UV-irradiation with riboflavin 254 nm/20 min 365 nm/30 min 436 nm/30 min glutaraldehyde aldehyde sugars (14 days) 0.1 %/10 min %/10 min %/20 min glyceraldehyde methylglyoxal ribose glucose glycolaldehyde Spoerl and Seiler, J Refract Surg 1999;15:711. CXL: Riboflavin Absorption Spectrum nm wavelength (nm) CXL: UVA 365/370nm CXL: Different Devices Avedro -USA CXLUSA - USA Peshke IROC Innocross Sooft Vega X-Link *Web-links are on CXL: Outcomes and indications Strengthens/stiffens corneas with UV light and riboflavin drops 98-99% 99% effective* CXL: Outcomes and indications Goal: prevent corneal ectasia from progressing to penetrating keratoplasty Indications: Keratoconus Pellucid Marginal Degeneration Post-Refractive Surgery ectasia Corneal melting Infectious keratitis *Raiskup-Wolf F, et. al.collagen crosslinking with riboflavin and ultraviolet-a light in keratoconus: Long-term results. J Cataract Refract Surg May;34(5): Page 5

6 CXL: Outcomes and indications CXL: Outcomes and indications LASIK AND CXL LASIK AND CXL Riboflavin/UVA Riboflavin alone Riboflavin/UVA Riboflavin alone Anterior View Posterior View Riboflavin + UVA vs. Riboflavin alone, 30min treatment Asota, Fant, Edelhauser, and Stulting, unpublished CXL: Outcomes and indications UNEVEN RIBO DISTRIBUTION CXL WITH CK CXL Outcome in the US: A Single Center Review CXL Algorithm: Work in Progress NO Independent Risk Factors Maximum K < 55D Monitor? BSCVA > 20/40 Independent Risk Factors Stable Disease Maximum K 55D Treatment Decision BSCVA 20/40 CXL? CXL? CXL PKP Risk Factor? Progressive Disease CXL Consider BSCVA? of n cross-linking: a review of Hersh PS. Corneal collagen Chang CY, Hersh 014 Nov;40(6): year outcomes. Eye Contact Lens. 20 CXL: Myths Epithelium has to be removed for CXL Wait till ectasia progresses before CXL Older patients don t benefit from CXL Insurance will pay for CXL soon CXL effect is temporary CXL not approved because it s dangerous Page 6

7 CXL: Possible Complications/Concerns Radiant exposures 5.4 J/cm J/cm 2 (9 %) 0.33 J/cm 2 (7 %) 0.14 J/cm 2 (2.1%) 0.12 J/cm 2 (1.9%) Radiant Energy is Below Damage Threshold 70 J/cm J/cm 2 Damage thresholds 70 J/cm2 7.7 J/cm2 CXL: Possible Complications/Concerns Real World UV All Exposed Tissues: J/cm 2 /day in 3-4 hrs outdoors ~60J/cm 2 /day of solar UVA Cornea 5J/cm 2 in min in Summer CXL exposure=3 mj/cm 2 CXL: Possible Complications/Concerns CXL: Epi-Off Vs Epi-On Debate Infection Epi-off only reported Corneal Haze and Scarring Epi-off only reported Progression of disease Intraocular Inflammation Worsening of refraction Inability to tolerate contact lenses Need for PKP Epi-On Longer load time Late stage technique More ribo needed No epi defect Less chance of infection and haze No reported complications Epi-Off Shorter load time Early adopted technique Less ribo needed d Large epi defect Slower recovery Higher risk of infection and haze Reported complications CXL: Epi-Off Vs Epi-On Debate ParaCel Transepithelial CXL Treatment Kit 0.25% Riboflavin-5-Phosphate, HPMC, Permeability Enhancers & 0.25% Riboflavin-5-Phosphate, Saline Dextran free Two stage application procedure for optimal riboflavin penetration and excellent patient comfort CXL: Epi-Off Vs Epi-On 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. The ParaCel / KXL System is not approved for sale in the United States Images Courtesy: Mr Imran Rahman Page 7

8 CXL: Long Term Outcomes 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): DESIGN: To evaluate the long-term results of corneal collagen cross-linking (CXL) in patients with progressive keratoconus (40 eyes, 32 KC) patients. MAIN OUTCOME MEASURES: BCVA, UCVA, MRSE, max-k, mean-k, CCT, and anterior and posterior elevation at the apex (baseline; 1, 3, 6 months after CXL; 1, 2, 4, and 5 years later). RESULTS: The mean-k, max-k, UCVA, and astigmatism showed no change over 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 years after CXL. CONCLUSIONS: Treatment of progressive keratoconus with CXL can stop disease progression, without raising any concern for safety, and can eliminate the need for keratoplasty. CXL: Long Term Outcomes 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 Feb;112(2): Purpose: : Riboflavin and ultraviolet-a induced cross coss linking g(c (CXL) is sapo promising therapeutic eapeu option to halt the progression of keratoconus. The aim of the study was to prove a long-term stabilizing effect of riboflavin and ultraviolet-a induced collagen CXL in young and otherwise healthy patients with progressive keratoconus and a corneal thickness of at least 400 μm on average 10 years after treatment. CXL: Long Term Outcomes (Theuring et al) Results: : The mean preoperative age was 28 ± 7 years (range years), 4 patients were female (7 eyes) and 16 patients (23 eyes) were male. Preoperatively, the mean K-value on the apex of keratoconus was 62 ± 13.2D which h showed a statistically significant reduction after 10 years to 55 ± 8.1 D (p = 0.001). The mean KMAX (53 ± 8.2 versus 49 ± 6.6 D) and KMIN values (48 ± 5.5 vs. 45 ± 5.1 D) also showed a statistically significant decrease (p = 0.001) CXL: Long Term Outcomes (Theuring et al) The mean change in corneal thickness at the 10-year follow up was 46 μm (p = 0.001). Bias possibly occurred because of a change of the measurement method from ultrasound pachymetry y to optical pachymetry with Oculus Pentacam. Neither corneal endothelium nor deeper structures suffered any damage. Only two patients had continuous progression of keratoconus and needed a reapplication of CXL. CXL: Long Term Outcomes (Theuring et al) Conclusion/Summary: CXL is a promising therapeutic option for progressing keratoconus to obtain long-term stabilization. There was a sustained improvement of all K- values and BCVA 10 years after initial CXL treatment. CXL is minimally invasive and easy to handle. Possible side effects, such as endothelial damage was not observed. CXL: Future Directions/Applications Transepithelial CXL High Irradiance CXL Oxygen Enhanced CXL Accelerated CXL with Pulsed Illumination Intrastromal CXL LASIK Xtra & PRK Xtra Topographic Guided - CXL Alternative Agent CXL Selective CXL Page 8

9 CXL: Future Directions/Applications Accelerated CXL Original CXL studies at Dresden Technical University in the late 90s were conducted with 3mW/cm2 irradiance, requiring 30 Min UV time Amplification of Cross-Linking Chemistry The Bunson Roscoe Law of Reciprocity states that the UV photochemical biological effects is proportional to the total energy dose delivered, regardless of the applied irradiance and time The energy delivered by a UV source is the product of the irradiance of the light source and the delivery time Irradiance (mw/cm 2 ) x Time (seconds) = Dose (J/cm 2 ) Sodium Hydrosulfite Na 2 S 2 O 4 Demo 3 mw/cm 2 x 30 Minutes = 30 mw/cm 2 x 3 Minutes CXL: Avedro Riboflavin Family Name Formulation Procedure Application VibeX 0.1% Riboflavin 20% Dextran KXL Keratoconus & Post-LASIK Ectasia Epi-Off Expanding Management Paradigm 1) Patient Monitoring Approach Refractive Correction 2) Prophylaxis Approach Stabilization 3) Functional Approach Stabilization + Ref. Correction VibeX Rapid 0.1% Riboflavin HPMC KXL Keratoconus & Post-LASIK Ectasia Epi-Off ParaCel 0.25% Riboflavin HPMC, BAC EDTA, TRIS KXL Keratoconus & Post-LASIK Ectasia Epi-On VibeX Xtra 0.25% Riboflavin Saline The KXL System is not approved for sale in the US. Lasik Xtra Corneal Strengthening During LASIK Stromal Bed PRK/CXL Combo Topo-guided transepithelial PRK/CXL PRK ablation facilitates riboflavin penetration Minimizes surface healing time and PRK haze Does not remove already CXL tissues Statistical significance found in simultaneous vs. Sequential group, although Tx effects seen in both groups (198 vs. 127 eyes) Better BSCVA (p<0.001), reduction in MRSE (p<0.005) and reduction in K values (p<0.005) Gomes JA, Tan D, Rapuano CJ, Belin MW, Ambrósio R Jr, Guell JL, Malecaze F, Nishida K, Sangwan VS; Group of Panelists for the Global Delphi Panel of Keratoconus and Ectatic Diseases. Global consensus on keratoconus and ectatic diseases. Cornea Apr;34(4): Stojanovic A, Zhang J, Chen X, Nitter TA, Chen S, Wang Q. Topography-guided guided transepithelial surface ablation followed by corneal collagen cross-linking performed in a single combined procedure for the treatment of keratoconus and pellucid marginal degeneration. J Refract Surg Feb;26(2): Kanellopoulos AJ. Comparison of sequential vs same-day simultaneous collagencross-linking linking and topography-guided guided PRK for treatment of keratoconus. J Refract Surg Sep;25(9):S Page 9

10 PRK/CXL Combo: Athens Protocol Step 1: Minimum ablation strategy ~ 70% of sphere and cylinder, OZ 5.5mm & ablation 50 µm, 0.02% MMC (20 seconds) and BSS irrigation (balance salt solution) Step 2: CXL Post-Op Management Topical antibiotic/steroid/1000 mg Vitamin C/Sunglasses Kanellopoulos AJ, Binder PS. Management of corneal ectasia after LASIK withcombined, same-day, topography-guided guided partial transepithelial PRK and collagen cross-linking: the athens protocol. J Refract Surg May;27(5): Hersh Vision 31. Group PRK/CXL Combo: Athens Protocol Goal in KC/Ectasia is mainly therapeutic Potential Use in patients at risk for ectasia Touch-up up after Intacs Kanellopoulos AJ, Binder PS. Management of corneal ectasia after LASIK withcombined, same-day, topography-guided guided partial transepithelial PRK and collagen cross-linking: the athens protocol. J Refract Surg May;27(5): Hersh Vision 31. Group PRK/CXL Combo: Biomechanics! ICRS/IntraCornealIntraCorneal Ring Segment Pre: Post: 10 months PMMA proves biocompatible KeraRing Mediphacos, Brazil Ferrara Ring AJL, Spain Intacs Oasis Medical, USA 1984 Adjustable Ring Courtesy of Renato Ambrosio, MD, PhD Colin J, et al. Correcting keratoconus with intracorneal rings. J Cataract Refract Surg 2000; 26: Miranda D, Sartori M, Francesconi C, et al. Ferrara intrastromal corneal ring segments for severe keratoconus. J Refract Surg. 2003;19: ICRS: Intacs & Arc Shortening Effect Barraquer s law of thickness α thickness, and 1/α diameter Potential structural support? Ablation or incision may further weaken KC corneas Stability? (Bedi et al, 2012; 92.9%) Flattening central to Device Midperipheral to Peripheal Steepening Centripetal apical shift ICRS: New Femto-Second Application Intralase laser creates channels & incision site More reproducible Sutureless? More effective? Channel Dimensions Better post-op op comfort? Post-Intacs, Day 1 Post-PKP, PKP, 1 week Page 10

11 ICRS: New Intacs SK Series SK series (Currently not available in US) 400 SK :K 57-62D, & Cyl < 5D 450 SK :K > 62D, & Cyl > 5D Alio JL et al (2006): better results with mean K 53D! ICRS: New Intacs Algorithms Mean UCVA (logmar) Mean BSCVA (logmar) Max Flattening Combo Intacs/CX L 350 Sequential Intacs/CXL 350 Symmetric 450 Intacs/CXL Assymmetr ic 210 /450 Intacs/CXL Single Segment 5.84 D 5.34 D 5.85 D 6.59 D 7.23 D Increased Coupling Courtesy: Josef Ruckhofer, MD Courtesy: Rex Hamilton, MD (UCLA Jules Stein) ICRS: New Intacs Incision Offset 10 0 offset in femto incision Move Intacs segment from incision site Wound gape Suture ICRS: Post-Op Goals Despite CL material/design advancements 12-26% 26% KC patients seek surgical Tx 1-3 PKP most common Alternative keratorefractive Treatment Options Ablative, Incisional,, Thermal, Additive Lewinger S et al 4 : BCVA unchanged sp Intacs, but mean UCVA improved from 20/200 to 20/50 (N=58 eyes) 72.2% reported significant VA improvement 1. Crews MJ et al. The Clinical Management of Keratoconus: A 6 Year Retrospective Study. CLAO J 1994;20(3): Gordon MO et al. Baseline Factors Predictive of Incident of Penetrating Keratoplasty in Keratoconus. Am J Ophthalmol 2006;142(6): Betts AM et al. Visual Performance and Comfort with the Rose K Lens for Keratoconus (CLEK) Study. Optom Vis Sci 2002;79(8): Levinger S and Pokroy R. KC managed with Intacs One Year Results. Arch Ophthalmol 2005;123: ICRS: Post-Op Goals KC OU; Dual Intacs in OD, 7 yrs 1Mth, Post-Intacs Intacs exchange UCVA 20/200 UCVA 20/200 MR: -2.00, x105 20/25- MR: , x095 20/25+ Poor SCL VA with KC progression & Pt Ed. on specialty CLs but happy Intolerant to Duette hybrids with DW soft torics 1 Month Pre-Op ICRS: Post-Op Goals Primary Goals Re-Evaluate contact lens options and goals Defer immediate need for keratoplasty Secondary Goals Reduce anisokonia Potentially improve visual functions Ibrahim TA (2006; N=186 eyes; 5 Yrs) UCVA & BCVA improved in 85.23% & 87.9% BCVA gain of > 3 lines in 19.7% BCVA gain between 1-3 lines in 68.2% Page 11

12 ICRS: Biomechanics! Pre Op: Def. Ampl.: 1,35 mm CK/Conductive Keratoplasty Initial approval to Tx low to moderate hyperopia (+0.75D to +3.00D with < -0.75D cylinder) FDA panel approval for Near Vision CK Other off-label applications Regular and irregular Cyl (Post-surgical surgical and KC) Post Op: Def. Ampl.: 1,15 mm CK/Conductive Keratoplasty Tissue resistance to current flow Radiofrequency via a 450 x 90 micron probe Self regulated and homogenous thermal profile 65 0 Cto75 0 C Denatures/Shrinks conreal collage Radial Stress/Tension Lines Photo courtesy of Roy Rubinfeld, MD CK/Intacs /CXL Combo Stabilize and enhance surface symmetry CXL stabilizes KC and may retain other Tx effects Intacs flatten and more centrally shift cone apex CK further decreases residual Cyl Expanding Management Paradigm 1) Patient Monitoring Approach Refractive Correction 2) Prophylaxis Approach Stabilization 3) Functional Approach Stabilization + Ref. Correction Page 12

13 SK/PTK: Old Fashioned But Not Gone! Superficial keratectomy (SK) ± Phototherapeutic keratectomy (PTK) Treatment of KC apical nodules Improve surface optical characteristics Improve contact lens tolerance Gomes JA, Tan D, Rapuano CJ, Belin MW, Ambrósio R Jr, Guell JL, Malecaze F, Nishida K, Sangwan VS; Group of Panelists for the Global Delphi Panel of Keratoconus and Ectatic Diseases. Global consensus on keratoconus and ectatic diseases. Cornea Apr;34(4): Keratoplasty: Timing for Referral/Consult Unsatisfactory/Non-functional functional vision Specialty CL Devices Advanced central Scarring CL Intolerant Spectacles Rx in CL intolerant Pts Recurrent hydrops Dangerously thin cornea? Keratoplasty: Lamellar Vs PKP Techniques With PKP, there is still the considerable risk of endothelial rejection: This Risk is Forever Lamellar techniques may be beneficial for KC patients who are typically younger and would otherwise have lifelong risk of rejection Keratoplasty: DALK.chadrostron.co.uk www. Keratoplasty: DALK PKP carries lifelong risk of endothelial rejection, so MDALK may benefit younger KC patients who has higher accumulative risk Technically more difficult, longer surgery Up to 25% of cases require PKP conversion Endothelial protection over PKP still debated Page 13

14 PKP: Intraoperative Challenges Perfect centration is critical to minimize torsional Cyl and HOA Donor/Host alignment Classic vertical punch requires tight sutures to withstand IOP Up to 4% wound dehiscence after removal PKP: Intraoperative Challenges Tight and non-uniform sutures result in regular and irregular post-operative operative Cyl Typically 5D at 3 Mths, may reduce to 3.5D 1 selective suture removal (if interrupted sutures) Suture adjustment (single running suture) Stable VA generally at Mths 2 BCVA 20/40 in 73.2% with low rate of recurrent KC 20/50 at 6 Months 20/40 at 1 Year 20/20 at 2 Years 1. Karabatsas CH, Cook SD, Figueiredo FC, Diamond JP, Easty DL. Combined interrupted and continuous versus single continuous adjustable suturing in penetrating keratoplasty: a prospective, randomized study of induced astigmatism during the first postoperative year. Ophthalmology Nov;105(11): Pramanik S, Musch DC, Sutphin JE, Farjo AA. Extended long-term outcomes of penetrating keratoplasty for keratoconus. Ophthalmology Sep;113(9): IEK / Intralase Enabled Keratoplasty IEK: New Frontier with Shaped Grafts Theoretical advantages Bladeless Higher precision Reduced technical difficulty Potentially increasing wound stability and decreasing post-operative operative Cyl Ability to perform shaped transplants IEK: New Frontier with Shaped Grafts Better wound structure Less suture tension = less induced cyl Early suture removal for faster visual recovery course Suture Not Tight Prevents Leakage Intraocular Pressure Gomes JA, Tan D, Rapuano CJ, Belin MW, Ambrósio R Jr, Guell JL, Malecaze F, Nishida K, Sangwan VS; Group of Panelists for the Global Delphi Panel of Keratoconus and Ectatic Diseases. Global consensus on keratoconus and ectatic diseases. Cornea Apr;34(4): Page 14

15 Pre- and Post-Op Optical Rehabilitation Post-KP CLF: Challenges Post-KP CL designs choices depends on Patient lens wear history Corneal topography various possible profiles RGP Soft KC Piggyback Recessed CL System Hybrid Scleral Cutler in Hom, Manual of Contact Lens Prescribing and Fitting Post-KP CLF: Timing Post-ICRS CLF: Challenges Reduced VA from irregular surface 6-12 months post surgery Nepomuceno RL, Boxer Wachler BS, Weissman BA. Feasibility of Contact Lens Fitting on Keratoconus Patients with INTACS Inserts. Cont Lens Anterior Eye Dec;26(4): Segment bearing/binding Reduced Tear Exchange Keratitis/erosion Hypoxia Post-ICRS CLF: Challenges Greatest flattening effects over segments 7-9 ICRS creates midperipheral zone(s) of elevation Old: Apical bearing/decentration/edge lift New: Midperipheral bearing? Better Centration & edge lift? Post-ICRS CLF: Challenges 6.0mm Optical Zone 7.0mm Optical Zone 7. Smith KA et al. High-DK Piggyback Contact Lenses Over Intacs for Keratoconus: a Case Report. Eye Contact Lens 2008;34(4): Ucakhan OO et al. Contact Lens Fitting for Keratoconus after Intacs Placement. Eye Contact Lens 2006;32(2): Nepomuceno RL et al. Feasibility of Contact Lens Fitting on Keratoconus Patients with Intacs Inserts. Cont Lens Ant Eye 2003;26(4): Intacs Ferrara Ring Page 15

16 Post-ICRS CLF: Considerations Implantation Strategies Depth Number of Segment(s) ICRS Designs Location of Elevation (ie, OZ) Magnitude of Elevation (ie ie, Intacs SK) Post-Op MR & VA Stabilization (Intacs Vs. CXL Vs. CXL/Intacs ) Pre-op Expectations Management Pre-Op CL history Post-ICRS CLF: Timing Alio JL et al 1 : 3 mths stabilization May take up to 12 mths for advanced KC Post-ICRS fitting can defer PK in severe KC 2 Ucakhan O et al, 2006 Post-ICRS Fitting Goals Pre-Op goals and CL Hx Patient interview & education BCLVA, tolerance, I & R Minimize excess pressure on ICRS Preop De-epiepi Re-epiepi Remodel 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: Ucakhan OO et al. Contact Lens Fitting for Keratoconus after Intacs Placement. Eye Contact Lens 2006;32(2):75-7. Post-ICRS CLF: Soft KC CLs Satisfactory Post-Op BSVA (mild HOA Sx) Enhanced CT profile: Gradient CT control Large OZ: Sag depth to better drape entire cornea, Independent Curvature System: BC and FC Wide Rx Range: High Sph and Cyl Rx Post-ICRS CLF: Corneal GPs Pending ICRS nomogram used Modern larger diameter GP & multiple PC zones Enhanced Sag depth/bozd Quadrant-specific & Reverse Geo. designs Modify PC systems to aid tear dynamics Bastos L. Fitting Keratoconus After intracorneal Ring Implants. Contact Lens Spectrum 2011;11:40-2 Post-ICRS CLF: Piggyback CLs If can not achieve alignment with ICRS, then minimize positive pressure over Segment by High DK disposable soft High DK custom soft Subjective comfort Lens Centration Tear Exchange Ocular surface health Improve CLVA? Post-ICRS CLF: Hybrid CLs Reverse Geometry with 6.5mm OZ New SK series (400/450): 6mm OZ Limited vaulting? Non-SK series: 7mm OZ Alignment with soft skirt? Hyper dk generations reduces hypoxia concerns GP: Dk 130 Soft Skirt: 84 Page 16

17 Post-ICRS CLF: Hybrid CLs Post-ICRS CLF: Scleral-GPs Minimally sustainable vault over cornea + limbus Scleral/Conj alignment & weight distribution Liquid bandage protects ICRS segment(s) and improves VA Therapeutic properties Courtesy of J Sonsino O.D. Courtesy of Dr. Shelley Cutler CLEI CLF Study: Outcome Chang C, Shin A, & Hersh P : Presented findings of 329 eyes at ASCRS/GSLS 2012 (Data to be published). Non-Surgical Surgical Success Rate 94.2% 97.3% Habitual VA 20/ /57.7 Final CLVA 20/ /28.7 CLEI Post-ICRS CLF Study: Outcome Chang C, Shin A, & Hersh P: Retrospective review of consecutive post-operative operative cases (Data to be published). Overall Success Rate = 97.7% (84/86) Surgery Type N = 86 Success Collagen Crosslinking (CXL) % (39/41) Tolerance at Presentation Tolerance after Fitting 63.4%* 38.2%* 95.8% 98.5% CXL & Intacs % (33/33) PKP % (12/12) CLEI Post-ICRS CLF Study: Outcome CLEI Post-ICRS CLF Study: Outcome s/p CXL-Intacs CL Tolerance at 48.1%* Presentation Post-CXL/ CXL/Intacs CLF 100% (33/33) Success LogMAR Habitual VA 0.44 (20/55.6) 90.9% 50.0% 0% 75% 77.8% 80.0% LogMAR Final CLVA 0.17 (20/29.6) *Tolerance is defined as patients who present with CLs on eyes regardless of functional wear time Page 17

18 Conclusion Expanding KC management paradigm Specialty contact lens devices, including corneal-gps, continue to be effective visual rehabilitation tools Early detection and stabilization optimizes patient outcome and preserve PKP as future option if need arises Interdisciplinary Co-management approach essential Post-operative operative use of specialty contact lens devices may augment surgical benefits New ICRS nomograms followed by modern CL designs 1 Discussions of Post-OP expectations, timeline and goals! 1, 2 1. Ucakhan OO et al. Contact Lens Fitting for Keratoconus after Intacs Placement. Eye Contact Lens 2006;32(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: Conclusion: Use Your Resources!! Maximizing patient outcome & standard of care Regional/Local Co-Management Network!! International KC Academy of Eye Care Professionals (info@keratoconusacadey.com) Optometric Council On Refractive Technology ( Optometric Cross Linking Society ( National KC Foundation ( GP Lens Institute ( AAO ( AAOpt ( ARVO ( THANK YOU Page 18