Accelerated Transepithelial CXL for keratoconus in pediatric population Enrique O. Graue-Hernández, Andrew Olivo-Payne, Lucero J Pedro-Aguilar, Arturo.

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Accelerated Transepithelial CXL for keratoconus in pediatric population Enrique O. Graue-Hernández, Andrew Olivo-Payne, Lucero J Pedro-Aguilar, Arturo Ramírez-Miranda, Alejandro Navas Instituto de Oftalmología Fundación Conde de Valenciana, Mexico City, Mexico Universidad Nacional Autónoma de México INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA Financial interests EG, AO, LO : none ARM: Carl Zeiss Meditec (L) AN: Alcon Laboratories (L), Carl Zeiss Meditec (C); STAAR Surgical Company (L) Non-FDA approved medical devices Non-FDA use of FDA approved medical devices

Introduction Progression of keratoconus can be much faster in children, specially in those with allergic conjunctivitis – visual impairment – inability to obtain satisfactory correction – intolerance to rigid gas permeable contact lenses Corneal crosslinking halts progression in adult patients. Riboflavin-UVA-Induced Corneal Collagen Cross-linking in Pediatric Patients, Aldo Caporossi, Cornea _ Volume 31, Number 3, March 2012 Wittig-Silva et al Three-Year Results of CXL for Keratoconus. American Academy of Ophthalmology 2014 INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA

Purpose To evaluate the effectiveness and safety of accelerated trans-epithelial CXL with the KXL System (Avedro, Waltham, MA) Children with documented keratoconus progression over last 12 months (Change >1D) Topographic and refractive changes INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA

Methods Retrospective case-series Consecutive pediatric patients (<16 years of age) Different stages of KC (Amsler- Krumeich grade I to III) Inclusion criteria: – Documented disease progresion (>1 D in 12 months) – Pachymetry ≥ 400 microns at the thinnest point – Age < 16 years Exclusion criteria : – Corneal opacities requiring corneal transplantation – Contact lens intolerance requiring corneal transplantation – Vogt striae INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA

Methods Crosslinking – High Fluence - Accelerated trans-epithelial CXLParaCel™ 4 minutes – VibeX Xtra™ 6 minutes – 30 mW/cm2 of UV radiation x 180 seconds= 5.4 J/cm2 Variables: UCDVA, BCDVA, central pachymetry, thinnest point, Kmax, Kmin, K mean Statistical analysis: one tail T-test to compare preop and postop variables INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA

Results Twenty-three eyes of 14 consecutive pediatric patients (<16 years of age) 11 male patients, 3 female Mean age of the 14 patients (23 eyes) was 13.7 years ±1.4. Mean follow-up was 17 months ±4.1 (range months INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA

Results: preoperative characteristics VariableMeanSDRange Age (years) Kmean (D) to 68.5 Kmax to 69.4 Kmin to 56.6 Pachymetry : Thhinnest point to 532 INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA

ParameterValuesP value BaselinePostoperative UDVA (LogMAR) 0.92 ± ± * CDVA (LogMAR) 0.26 ± ± * Kmin (D)49.83± ± * Kmax (D)56.18± ± Kmean (D)53.63 ± ± * Pachymetry (microns) 433 ± ± Results * p<0.05 one tailed T-test INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA

Discussion CXL has shown to improve UDVA, BCVA, decrease K readings as well as KC indexes Few published reports on CXL in pediatric patients. Transepithelial crosslinking has less biomechanical effect, however the clinical signficance is still uncertain Advantages of transepithelial crosslinking are quicker rehabilitation, less pain and discomfort and no risk of infection. Wittig-Silva et al Three-Year Results of CXL for Keratoconus. American Academy of Ophthalmology 2014 INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA

Previous studies have shown up to 50% of pediatric patients treated with transepithelial crosslinking require retreatment 1. In our study, with average 1 year follow-up, UDVA, BCVA, Keratometries and pachymetry remained unchanged Caparossi et al. Transepithelial corneal collagen crosslinking for progressive keratoconus: 24-month clinical results. Journal of Cataract & Refractive SurgeryVolume 39, Issue 8, August 2013, Pages 1157– 1163 INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA

High fluence accelerated transepithelial crosslinking appears to halt progression in pediatric population Also a mild improvement in UDVA (p=0.001) and BCVA (p=0.029) were noted One eye (4.3%) out of the 23 eyes had progression after 12 months of treatment. Pre operative high keratometry readings (>58 D) are a risk factor for treatment failure. Preoperative Km readings: 66.73D No serious adverse events Pain and discomfort resolve quickly ( first 24 hours) Asri D, Touboul D, Fournie P, et al. Corneal collagen crosslinking in progressive keratoconus: multicenter results from the French National Reference Center for Keratoconus. J Cataract Refract Surg 2011;37:2137–43. INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA

Conclusions Preliminary results of accelerated transepithelial CXL were encouraging, with no evidence of progression in 95.6% of studied eyes over 10 months. Further studies are necessary to evaluate long-term results and efficacy of accelerated transepithelial CXL INSTITUTO DE OFTALMOLOGÍA FUNDACIÓN CONDE DE VALENCIANA