Corneal Collagen Crosslinking: An Introduction to the New Paradigm in Keratoconus. Michael Waggoner DO McDonald Eye Associates Fayetteville AR
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1 Corneal Collagen Crosslinking: An Introduction to the New Paradigm in Keratoconus Michael Waggoner DO McDonald Eye Associates Fayetteville AR
2 Learning Objectives Gain knowledge in: The history of the development of corneal crosslinking the biochemical basis of the crosslinking treatment the indications and uses of crosslinking in clinical practice the future directions and areas of research in crosslinking treatment the current regulatory state of corneal collagen crosslinking the role crosslinking plays in the treatment of corneal ectasia, specifically keratoconus
3 Keratoconus: The Algorithm Adapted: Global consensus on Keratoconus and Ectatic Diseases
4 Study the past if you would define the future -Confucious
5 1766 The first disease in this class is when all the cornea preserve his transparency and elevate itself in a form of a cone, the point of this is obtuse (blunted) and the base occupies the entire circumference of the cornea. there is another kind of disease where the cornea is not only high but the point is so acute and so highten ed that one at any time fears his breaking.
6 William MacKenzie published textbook describing features including: Cone shaped cornea thinning apical scarring commencement in puberty asymmetric, progressive disease Orthogonal and irregular astigmatism Uncertain etiology Limited correction by spectacles
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8 KCN: The Algorithm Adapted: Global consensus on Keratoconus and Ectatic Diseases
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11 Progression happens Over 8 years, corneal curvature: Mean increase1.60d 24% >3D ~30%(PK/DALK)
12 The History of Corneal Collagen Crosslinking
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17 Age Physiologic/Pathologic corneal crosslinking Diabetes mellitus Smoking
18 Dresden Protocol 9mm epithelial removal Saturation with 0.1% riboflavin in isotonic dextran 3mW/cm2 for 30min
19 Current Protocol (Epi Off) Central 7-9mm epithelial removal Robflavin (B2) in 20% dextran 5min prior every 5min during procedure UVA ( nm) for 30min 3mW/cm2 irradiance Total 5.4 joules (~15-20min at the beach) BCL with Abx/steroids for several weeks
20 Current primary indications 1. KCN 2. Post LASIK/post refractive ectasia 3. In conjunction with topography guided PRK
21 Surgical procedure: molecular basis/rationale Riboflavin (vitamin b2) + UV light (365nm) + O2 ROS or activated riboflavin (?) Increases number of crosslinks between collagen fibers
22 Surgical procedure: molecular basis/rationale Riboflavin (vitamin b2) + UV light (365nm) + O2 ROS or activated riboflavin (?) Increases number of crosslinks between collagen fibers
23 Surgical procedure: molecular basis/rationale Riboflavin (vitamin b2) + UV light (365nm) + O2 ROS or activated riboflavin (?) Increases number of crosslinks between collagen fibers
24 Surgical procedure: In Vitro CXL effects 1. Increase stress-strain/cornal rigidity 72% porcine eye; 329% human eyes 2. Keratocyte apoptosis to depth of 300um 3. Reduced swelling of the cornea 4. Increased resistance to collagenase digestion
25 Surgical procedure: Efficacy Define work/efficacy: stability over time improved VAsc improved VAcc 1. Mean improvement 1 line BCVA at 1 yr 2. 1D flattening KMax 3. Halted progression of ectasia (Harsh 2011) (Kanellopoulos 2009) (Rubenfeld 2012) Ks: sim, avg, steep, max Thinning CL tolerance
26 Treated eyes : 2D flatter 2-10 lines better UCVA No studies >0.2logMAR loss BCVA Thickness data inconsistent Adverse effects uncommon and of low clinical significance CXL seems to be accepted worldwide as a breakthrough treatment in keratoconous evidence is limited due to the lack of properly conducted RCTs
27 Surgical procedure: Complications 1. Loss BCVA 2. Toxicity 3. Corneal edema 4. Sterile infiltrates 5. Infectious Keratitis 6. Delayed Epithelial healing 7. Stromal scars Loss of bcva: Uncommon (Cochrane) >35yo pre-op BCVA 20/25 (Koller JCRS 2009)
28 Surgical procedure: Complications Toxicity Keratocyte 0.5mW/cm3 Die/apoptosis Don t repopulate for >6months Endothelial Typically transient Depends on UV dose (time and wattage) Rare if corneas >400um Decreasing incidence w/depth
29 Surgical procedure: Complications Corneal edema Sterile infiltrates up to 7% HS-type infiltrates DLK in post LASIK ectasia Resolved with normal treatment Infectious keratitis Primarily with epi-off treatments Bacterial, acanthamoebal, HSV (reactivation) Delayed epithelial healing / LSCD Stromal scars
30 Regulatory status
31 Research AVEDRO Epi-Off Shorter loading time May crosslink more completely than epi-on Can result in sub epithelial fibrosis Infectious keratitis/lscd CXL-USA Epi-On Early BCVA / minimal pain Earlier refractive stability: glasses/ctl at one month Less complete cross linking effect Variable riboflavin depth
32 US multicenter clinical trial Keratoconus & Corneal ectasia after refractive surgery Active CXL and Sham group Primary efficacy: 1D change in Kmax Average was 1.6D flattening in 12mo Data submitted in 2012 to FDA Currently Avedro responding to comments
33 Avedro Accelerated cross linking Higher irradiance - 2mW for 30min = 5.4J/cm3 n=226 Randomized - epi-off vs placebo ACOS 4000 subjects (2000 KCN, 2000 refractive sx ectasia) 15mW/cm3 for 8min, 30mW/ cm3 for 4min, 45mW for 2:30 LASIK Xtra Improve safety, improve refractive stability Performed after excimer treatment with the flap up 90s B2 soak Epi-On study KXL2 system Topography-guiided crosslinking with eye tracking Tx: low myopia and astigmatism (rgular and irregular)
34 >8yo Inclusion: FFKC, KCN, PMD post operative ectasia Post RK with visual fluctuations >300um thickness >6mo since last corneal surgery Exclusion: Marked corneal scarring Pregnant Active herpetic disease
35 Future directions/areas of (international) research Optimum duration of Treatment / Accelerated CXL Post RK fluctuations Infectious keratitis Sterile ulcers Corneal edema Combined procedures
36 KCN: The Algorithm Adapted: Global consensus on Keratoconus and Ectatic Diseases
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40 Gomes et al. Global consensus on Keratoconus and Ecstatic Diseases. Cornea 34: Abdelaziz L, Barbara R. History of the Development of the Treatment of Keratoconus. International Journal of Keratoconus and Ecstatic Corneal Diseases. 2(1): Grzybowski A, McGhee C. The early history of keratinous prior to Nottingham s landmark 1854 treatise on conical cornea: a review. Clin Exp Optom 96: Kim T. CXL Background and Mechanism ASCRS Symposium S-14: Update on Corneal Collagen Crosslinking. San Francisco, CA Stulting D. Complications of CXL ASCRS Symposium S-14: Update on Corneal Collagen Crosslinking. San Francisco, CA Hovanesian J. Safety and Efficacy for Ectatic Disease (Literature Review) ASCRS Symposium S-14: Update on Corneal Collagen Crosslinking. San Francisco, CA Rubenfeld R. Update on U.S. Clinical Trials: CXL USA ASCRS Symposium S-14: Update on Corneal Collagen Crosslinking. San Francisco, CA Hersh P. Update on US Clinical Trials: Avedro ASCRS Symposium S-14: Update on Corneal Collagen Crosslinking. San Francisco, CA McGheee C. Treatment paradigms in keratoconus. World Cornea Congress VII. San Diego CA Wagner H et al. Collaborative Longitudinal Evaluation of Keratoconus. Contact Lens & Anterior Eye 30: ( Sykakis E et al. Corneal collagen cross-linking for treating keratoconus (review). The Cochrane Library. Issue , Issue 3(Review) References The future ain t what it used to be.
41 Thank you
Keratoconus. Progressive bilateral ectasia. Onset puberty. Prevalence 1:2000. 20% progress to transplantation. Pathogenesis unclear
Keratoconus Progressive bilateral ectasia Onset puberty Prevalence 1:2000 20% progress to transplantation Pathogenesis unclear Increased pepsin and catalase Decreased collagen crosslinking cf normal Conventional
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