Table 3B: Summary of outcomes for epithelium-on (transepithelial) cross-linking (Pediatrics).

Study Study design/ Protocol No. of eyes Follow-up, months Criteria for Progression UV device/ UV energy/ Riboflavin Outcome
Overall Pre-op K (D) ΔK (D) ΔUCVA ΔBCVA Δ Refraction (D)
Salman, 2013 [38] Prospective comparative case series/ 3mW/cm2 30 min 44; 22 epi-on, 22 FE control 12 1. K > 45.0D
2. Inferior steepening > 1.0D in superior half of cornea
3. 1.0D of tomographic cyl progression/1 year
4. ↓ CDVA
5. New CL fitting/2 years
Opto XLink/ 5.4J/cm2/ 0.1% riboflavin with 15.0% dextran, trometamol and EDTA Improved mean UDVA, decreased mean simulated K, mean flattening of apical K Mean SIM K (treated): 49.98 ± 4.46
Mean SIM K (FE control): 48.78 ± 3.46
Mean SIM K (treated): -2.03 (P < 0.05)
Mean SIM K (FE control): +0.59 (P > 0.05)
Treated: From 0.95 ± 0.34 to 0.68 ± 0.45 (LogMAR) (P < 0.023)
FE control: From 0.84 ± 0.52 to 0.94 ± 0.22 (LogMAR) (P = 0.324)
Treated: From 0.51 ± 0.11 to 0.49 ± 0.09 (LogMAR) (P = 0.189)
FE control: From 0.42 ± 0.11 to 0.51 ± 0.21 (LogMAR) (P = 0.543)
SE (treated): -From 3.17 ± 2.72 to -2.87 ± 2.86 (P = 0.751)
SE (control): -3.72 ± 4.72 to -4.12 ± 2.42 (P = 0.032)
Buzzonetti et al, 2012 [36] Prospective case series/ 3mW/cm2 30 min 13 18 - CBM X-linker, VEGA/ 0.1% riboflavin with 15.0% dextran, trometamol and EDTA Improved CDVA but K readings and HOAs showed significant worsening Kmax: 48.90 ± 3.60 From 48.90 ± 3.60 to 52.90 ± 4.90 (P < 0.05) - From 0.19 ± 0.14 to 0.1 ± 0.1 (LogMAR) (P < 0.05) SE: From -3.10 ± 2.40 to -3.50 ± 2.90
Buzzonetti et al, 2015 [45] Prospective case series/ 10mW/cm2 9 min 14 15 - -/Riboflavin solution administered by iontophoresis (I-ON CXL) CDVA improved from 0.7 ± 1.7 to 0.8 ± 1.8. Unchanged SE, refractive astigmatism, topographic and aberrometric data. Unchanged mean thinnest point and endothelial cell density. Kmax: 47.6 ± 2.0 From 47.6 ± 2.0 to 48.0 ± 2.3 (P = 0.08) - From 0.7 ± 1.7 to 0.8 ± 1.8 (LogMAR) (P = 0.005) From -2.2 ± 2.7 to -1.5 ± 1.8 (P = 0.3)
Magli et al, 2016 [46] Prospective case series/ 10mW/cm2 9 min 13 18 ↑ max cone apex curvature ≥ 1D/6 months UV-X 2000; IROC/ Riboflavin 0.1% with EDTA and tromethamine without dextran or sodium chloride administered by iontophoresis (I-ON XL, SOOFT) Stabilisation of refractive UCVA and BCVA as early as 1 month after CXL. Kmax remained stable. Pediatric keratoconus progression halted. Kmax: 53.26 ± 3.88 From 53.26 ± 3.88 to 53.98 ± 7.94 (P = 0.04) From 0.67 ± 0.22 to 0.63 ± 0.36 (LogMAR) (P = 0.05) From 0.45 ± 0.28 to 0.42 ± 0.22 (LogMAR) (P = 0.03) -
Magli et al, 2013 [39] Retrospective/ 3mW/cm2 30 min 37; 14 epi-on, 23 epi-off 12 ↑ max cone apex curvature ≥ 1D/6 months Epi-on: Vega/ 0.1% riboflavin with 15.0% dextran, trometamol and EDTA
Epi-off: Vega CBM X linker/ 0.1% riboflavin in 20% dextran
Significant reduction in Kmax, Kmin, mean K in both the epi-off and epi-on groups. Epi-off: 50.13 ± 4.0
Epi-on: 49.27 ± 4.1
Kmax (Epi-off): -1.11 (P = 0.01)
Kmax (Epi-on): -1.14 (P = 0.02)
Epi-off: From 0.68 ± 0.21 to 0.67 ± 0.24 (LogMAR) (P = 0.1)
Epi-on: From 0.55 ± 0.33 to 0.54 ± 0.22 (LogMAR) (P = 0.3)
Epi-off: From 0.36 ± 0.1 to 0.36 ± 0.1 (LogMAR) (P = 0.8)
Epi-on: From 0.26 ± 0.2 to 0.27 ± 0.2 (LogMAR) (P = 0.5)
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UV = Ultraviolet pre-op = pre-operative FE = Fellow-Eye UCVA = Uncorrected Visual Acuity BCVA = Best Corrected Visual Acuity UDVA = Uncorrected Distance Visual Acuity CDVA = Corrected Distance Visual acuity Kmax = maximum keratometry Kmin = minimum keratometry K = keratometry epi-on = epithelium-on epi-off = epithelium-off EDTA = sodium Ethylenediaminetetraacetic Acid Trometamol = Tris-hydroxymethyl aminomethane SE = Spherical Equivalent CXL = Cross-Linking HOA = Higher-Order Abberations CL = Contact Lens D = diopters cyl = cylinder SIM = simulated max = maximum