| Study | Study design/ Indication | 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) |
| Caporossi et al, 2006 [12] | Prospective non-randomised open/ Keratoconus | 18; 10 treated, 8 FE control | 6 | - | Exerion-Sas/ Riboflavin 0.1% w dextran 20% | Reduction in mean spherical equivalent, improvement in morphologic symmetry with reduction in comatic aberrations. | - | Δ Mean K (treated): -2.1 ± 0.13 in central 3.0mm | Treated: 3.6 lines improvement (P = 0.0000112) | Treated: 1.66 lines improvement (Glasses) (P = 0.00071) | SE (treated): -2.5 |
| Vinciguerra et al, 2009 [10] | Prospective, non-randomised single-center/ Keratoconus | 56; 28 treated, 28 FE control | 12 | 1. Δ myopia and/or cyl of ≥ 3D/6 months 2. Mean central Δ K ≥ 1.5D in 3 consecutive topographies/ 6 months 3. Mean CCT ↓ ≥ 5% in 3 consecutive tomographies/ 6 months |
Peschke Meditrade/ Riboflavin 0.1% w dextran 20% | Improved UCVA and BSCVA, reduced APP and AK, reduced corneal and total wavefront aberrations. | SIM K steepest (treated): 50.37 | Treated: -6.16 (P < 0.05) | Treated: From 0.17 ± 0.09 to 0.27 ± 0.08 (LogMAR) (P < 0.05) | Treated: From 0.52 ± 0.17 to 0.72 ± 0.16 (LogMAR) (P < 0.05) | SE (treated): From -3.36 ± 2.64 to -2.96 ± 2.68 |
| Coskunseven et al, 2009 [17] | Prospective comparative/ Keratoconus | 38; 19 treated, 19 FE control | 5 - 12 | Increase in maximum K by 1D / 6 months | Peschke Meditrade/ Riboflavin 0.1% w dextran 20% | Progression of keratoconus stopped. ↓ in corneal curvature, SE refraction, and refractive cylinder. | Kmax (treated): 54.02 ± 4.15 Kmax (control): 48.32 ± 3.00 |
Treated: -1.57 ± 1.14 (P < 0.01) Control: + 0.04 ± 1.34 (P = 0.446) |
Treated: increased by 0.06 ± 0.05 (LogMAR) (P < 0.01) Control: decreased by 0.08 ± 0.12 (LogMAR) (P < 0.1) |
Treated: increased by 0.1± 0.14 (LogMAR) (P < 0.01) Control: decreased by 0.06 ± 0.09 (LogMAR) (P < 0.01) |
SE (treated): +1.03 ± 2.22 (P < 0.01) SE (control): + 0.03 ± 0.96 (P = 0.441) |
| Vinciguerra et al, 2009 [11] | Prospective, nonrandomized single-center/ Keratoconus | 28 treated, 28 FE control | 24 | Documented keratoconus progression in the previous 6 months. | Peschke Meditrade/5.4J/cm2/Riboflavin 0.1% w dextran 20% | Improved UCVA and BSCVA, reduced APP and AK, reduced corneal and total wavefront aberrations. | Steepest SIM K: 50.37 | SIM K: 50.37 to 49.02 (P = 0.03) |
From 0.77 ± 0.18 to 0.53 ± 0.19 (LogMAR) | From 0.28 ± 0.09 to 0.13 ± 0.10 (LogMAR) | From -3.37 ± 2.64 to -2.56 ± 2.68 (P = 0.03) |
| Wollensak et al, 2003 [1] | Prospective, non-randomised/ Keratoconus | 23 | 3 – 48 (Mean: 23.2 ±12.9) | Preoperative progression of K value: 1.42 ± 1.18 D in 6 months | 370nm; Roithner Lasertechnik/ Riboflavin 0.1% w dextran 20% | Progression of keratoconus stopped, visual acuity improved slightly. | Max K: 48-72 | -2.01 ± 1.74 (P = 0.0001) | NA | 1.26 ± 1.5 (P = 0.026) | SE: -1.14 ± 2.18 (P = 0.030) |
| Agrawal, 2009 [15] | Retrospective nonrandomised open label/ Keratoconus | 68 | 6 – 16 (mean follow-up: 10.05 ± 3.55) | 1. ↑ max K of 1.00 D/1 year 2. Patient reports of deteriorating BCVA 3. Need for new contact lens fitting > once/2 years |
CBM X Linker/Riboflavin 0.1% | BCVA improved slightly, astigmatism decreased, K value of the apex decreased, reduction in comatic aberrations | Mean max K: 53.26 ± 5.93 | -2.47 (54%) (P = 0.004), stable (38%) | - | 1 line improvement (54%), stable (28%) (P = 0.006) | Cyl: -1.2 ± 4.02 |
| Arbelaez et al, 2009 [16] | Prospective, nonrandomized/ Keratoconus | 20 | 12 | 1. ↑ maximum K readings in several measurements over 3-6 months 2. Changes in refraction 3. ↓ visual acuity and contact lens intolerance |
UV-X device/ Riboflavin | Improved UCVA and BSCVA. Reduced average keratometry reading, manifest refraction sphere and manifest cyl | Kmax apex: 51.89 ± 7.99 | -1.4 (P = 0.01) | 4.15 line improvement (P = 0.002) | 1.65 line improvement (P = 0.002) | Sphere: -1.26 (P=0.0033) Cyl: -1.25 (P = 0.0003) |