Corneal Collagen Cross-Linking Using Epithelium Disruptor Instrument in Progressive Keratoconus

PURPOSE: To compare the effects of accelerated corneal collagen cross-linking (CXL) in progressive keratoconus (KCN) patients via epithelium removal and transepithelial techniques, using Daya Disruptor (Duckworth and Kent, Hertfordshire, UK). METHODS: This study is a double-blinded, randomized clinical trial. Patients with documented bilateral progressive KCN were randomized into two groups: one eye underwent epithelium removal (Group 1), and the fellow eye underwent epithelium disruption (Group 2). The primary outcomes were best corrected visual acuity (BCVA) and uncorrected visual acuity (UCVA), Scheimpflug-extracted keratometric indices, and anterior segment-optical coherence tomography-derived epithelial thickness profiles. These parameters were evaluated before and 12 months after CXL. RESULTS: Sixty-four eyes from 34 patients with progressive KCN (34 eyes in the epithelium-removal group and 30 eyes in the epithelium-disruption group) were included. The mean ± standard deviation (SD) of age was 23.4 ± 3.8 years in the epithelium-removal group and 23.2 ± 3.5 years in the epithelium-disruption group. The mean ± SD of the preoperative spherical equivalent (SE), front maximum keratometry (K-max), back K-max, thickness of thinnest point, and corneal apex thickness were − 2.9 ± 3.0 diopter (D) and − 3.7 ± 3.1 D (P = 0.183), 53.8 ± 5.15 D and 54.4 ± 5.53 D (P = 0.653), −6.63 ± 2.40 D and − 6.68 ± 2.48 D (P = 0.131), 459.2 ± 37.4 μm and 460.8 ± 32.7 μm (P = 0.708), 470.5 ± 37.7 μm and 469.7 ± 33.1 μm (P = 0.679), and 55.4 ± 4.97 μm and 54.6 ± 7.16 μm (P = 0.767) in the epithelium-removal and epithelium-disruption groups, respectively. The mean ± SD changes of the UCVA and BCVA 12 months after CXL were − 0.1 ± 0.11 and − 0.02 ± 0.18 and − 0.04 ± 0.12 and − 0.02 ± 0.14 in the epithelium-removal and epithelium-disruption groups, respectively. No statistically significant improvement was observed in the UCVA and BCVA between the two groups (P = 0.868 and P = 0.937, respectively). The mean ± SD changes of the SE, superior epithelial thickness, corneal apex thickness, and thickness of thinnest point 12 months after CXL were − 0.21 ± 1.1 D and + 0.32 ± 1.6 D (P = 0.0001), −0.08 ± 0.26 μm and + 0.03 ± 0.33 μm (P = 0.028), −23 ± 11 μm and − 2 ± 6 μm (P = 0.0001), and − 25 ± 8 μm and − 3 ± 7 μm (P = 0.0001) in the epithelium-removal and epithelium-disruption groups, respectively. CONCLUSIONS: This study showed that the epithelium-disruption CXL using Daya has a similar potential for halting KCN progression as the epithelium-removal CXL. However, regarding the 12-month changes, the epithelium-disruption CXL is superior to the epithelium-removal CXL in the SE and corneal pachymetry.