Study | Study design/ Indications | No. of Eyes | Follow-up, months | Criteria for Progression | UV device/ Riboflavin | Outcome | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
– | – | – | – | – | – | Overall | Pre-op K (D) | Δ K (D) | Δ UCVA | Δ BCVA | Δ Refraction (D) |
Caporossi et al, 2010 [21] | Prospective, nonrandomised, open long-term trial/ Keratoconus | 88; 44 treated, 44 FE control | 48 | - | CSO Vega CBM X linker/ Riboflavin 0.1% w dextran 20% | Reduced mean K value, reduced coma aberration. Improved BSCVA and UCVA. | - | Mean K (treated): -2.26 ± 0.68 Mean K (FE control): +2.2 ± 1.24 |
Treated: +2.85 ± 0.81 (Snellen lines) | Treated: +2.03 ± 1.04 (Snellen lines) | SE (treated): +2.15 ± 1.19 (P = 5.1 x 10-10 |
O’Brart et al, 2015 [24] | Prospective cohort study/ Keratoconus | 65; 36 treated, 29 FE control | 84 | 1. ↓ UDVA/ CDVA by > 1 line 2. deteriorating refractive/ corneal astigmatism, SIM K/ Kmax by 0.75D/12-24 months |
-/ Riboflavin 0.1% w dextran 20% | Improvements in topographic and wavefront parameters evident at 1 year continue to improve after 7 years. | Mean Kmax (treated): 48.23 ± 3.49 Mean Kmax (FE control): 47.01 ± 3.54 |
Treated: -0.91 (P < 0.001) FE control: +0.86 (P < 0.05) |
Treated: From 0.32 ± 0.26 to 0.46 ± 0.5 (SDE) (P < 0.0005) FE control: From 0.56 ± 0.4 to 0.43 ± 0.37 (SDE) (P = 0.4) |
Treated: From 0.85 ± 0.25 to 0.96 ± 0.17 (SDE) (P < 0.0001) FE control: 0.91 ± 0.28 to 0.92 ± 0.29 (SDE) (P = 0.9) |
Mean SE (treated): +0.78 (P <0.005) Mean SE (FE control): -1.66 ± 2.51 to -1.72 ± 2.27 (P = 0.8) |
O’Brart et al, 2013 [19] | Follow-up study/ Keratoconus | 30 | 48-72 | 1. ↓ UDVA/ CDVA by > 1 line 2. ↓ refractive/ corneal astigmatism, K or cone apex power by 0.75D/12-24 months |
-/Riboflavin 0.1% w dextran 20% | Reduced mean spherical equivalent, mean simulated K, cone apex power. Improved CDVA. | Mean SIM K: 46.44 ± 3.4 | From 46.44 ± 3.4 to 45.6 ± 3.3 (P < 0.001) | From +0.27 ± 0.29 to +0.286 ± 0.31 (SDE) (P = 0.6) | From 0.8 ± 0.27 to 0.905 ± 0.2 (SDE) (P < 0.04) | SE: From -1.61 ± 1.97 to -0.79 ± 1.7 (P < 0.001) |
Hashemi et al, 2013 [20] | Prospective case series/ Keratoconus | 40 | 60 | 1. ↑ ≥ 1D in max K, manifest cyl error or MRSE 2. ↓ ≥ 2 lines of BCVA |
UV-X IROC/ Riboflavin 0.1% w dextran 20% | Improved BCVA. No change in mean K and max K, UCVA, and astigmatism. | Max K: 49.37 ± 3.48 | From 49.37 ± 3.48 to 49.13 ± 3.29 (P = 0.645) | From 0.67 ± 0.52 to 0.65 ± 0.51 (LogMAR) (P = 0.853) | From 0.31 ± 0.28 to 0.19 ± 0.20 (LogMAR) (P = 0.016) | Mean MRSE: From -3.18 ± 2.23 to -2.77 ± 2.18 (P = 0.174) |
Ucakhan et al, 2016 [22] | Prospective follow-up study/ Keratoconus | 40 | 48 | ↑ > 1D in Kmax/12 months | UV-X, IROC/ Riboflavin 0.1% w dextran 20% | Improved UCVA and BSCVA. Reduced mean Kmax. | Mean Kmax: 58.4 ± 5.5 | -1.2 ± 2.2 (P = 0.0046) | - 0.4 ± 0.2 (LogMAR) (P = 0.0001) | - 0.2 ± 0.2 (LogMAR) (P = 0.0001) | MRSE: From -6.2 ± 3.5 to -5.4 ± 3.8 (P = 0.04) |
Raiskup-Wolf et al, 2008 [18] | Long-term retrospective study/ Keratoconus | 241 | Max 72 | 1. ↑ max K 1D/1 year 2. ↓ visual acuity 3. New CL/2 years |
Fa. Peschke/ Riboflavin 0.1% | Reduction in steepening, improved BCVA | Kmax: 53.7 ± 7.5 | -2.57 ± 3.71 | - | -0.15 ± 0.18 | - |
Raiskup et al, 2015 [23] | Retrospective interventional case series/ Keratoconus | 34 | 132 (Mean: 131.9 ± 20.1) | ↑ apical K ≥ 1D/6-12 months | - | Reduced AK value, max K and min K. Improved CDVA. ECC is unchanged. | - | - | - | -0.14 (LogMAR) (P = 0.002) | - |