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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