Comparing the Effects of Accelerated CXL in Progressive Keratoconus via Epithelium Removal and Trans-epithelial, using Daya Epithelium Disruptor: An RCT

Purpose: To compare the effect of accelerated corneal collagen cross-linking (CXL) in progressive keratoconus patients via epithelium removal and trans-epithelial, using Daya Disruptor. Methods: 68 eyes from 34 patients with progressive keratoconus were included. After randomization, one eye underwent epithelium removal (group 1) and the fellow eye underwent Daya disruptor (group 2) procedure. Mean follow-up duration was 9 months. Primary outcomes were best spectacle-corrected and uncorrected visualacuities (UCVA), scheimpflug-extracted keratometric indices, and anterior segment ocular coherence tomography-derived epithelial thickness profile. Results: Mean ages of the patients were 23.3 ± 3.6 years. Changes of UCVA, mean K, astigmatism, global epithelial thickness, and total corneal thickness after 9-months follow-up at both groups were statistically significant. The amounts of changes were -0.1 LogMAR and -0.12 for UCVA, 0.2 D and 0.18 D for mean k, -0.57 D and -0.43 for astigmatism, -1.4 μm and -0.4 for global epithelial thickness, and 25 μm and 13 for corneal thickness, at group 1 and 2, respectively. Differences of changes of total corneal thickness and global epithelialthickness were significant between two methods (group 1˃ group 2). Conclusion: Both groups achieved significant improvement in UCVA, mean K, and astigmatism after 9 months follow-up. This study shows that Daya-disruptor procedure is as effective as epithelium-removal method with no significant difference in indices studied, except epithelial and total corneal thickness that might be considered as an advantage. We believe that this method differs from other types of trans-epithelial-CXL methods with intact epithelium.