Purpose
New improvements seem promising in enhancing corneal wound healing. In this prospective, randomized, single-blinded, controlled study, we tested the hypothesis that a new matrix therapy agent (Cacicol20®) would speed up the corneal healing and reduce ocular symptoms after the corneal cross-linking (CCL) with ultraviolet A (UVA) and riboflavin.
Methods
Forty eyes of 40 patients with progressive keratoconus were enrolled in the study. Accelerated CCL with riboflavin and UVA (9 mW/cm2 for 10 min) were performed. The central 8-9 mm of the corneal epithelium was removed using 20% ethanol. 40 eyes were randomized into two groups according to use of Cacicol20 eye drop prior to contact lens (CL) fitting at the end of the CCL. All patients were asked to use the medical agents postoperatively. All participants were monitored on three consecutive days after the CCL. Ocular symptoms including pain (graded on 1-10 scale), burning, stinging, tearing, and photophobia (graded on 0-3 scale) were noted. Conjunctival hyperemia was scored using a standardized photographic scale derived from McMonnies grading (1-6). On day 2 and 3, CLs were removed and corneal healing was evaluated. If there was no complete healing, the size of the corneal epithelial defect (CED) was measured.
Results
On day 2, while 16 eyes (80%) with Cacicol20 revealed complete healing, only 3 eyes (15%) revealed complete healing in the control group (p< 0.001). On day 2, the mean size of CED was 0.32±0.69 (Cacicol20) and 3.10 ± 3.25 mm2 (Control) (p= 0.001). On day zero, even though the ocular pain scores were lower in Cacicol20 group (7.50±1.23) when compared to control group (6.80±1.06), the difference did not reach statistical significance (p= 0.062). However, ocular pain scores were found to be lower in Cacicol20 group on day 1, 2 and 3 (p= 0.04, p=0.004 and p= 0.02, respectively). Compared to controls, in Cacicol20 group, burning scores were statistically significantly lower on day 1 and 2; stinging scores on day 2; tearing scores on day 2 and photophobia on day 1 and 2 (p< 0.05). Conjunctival hyperemia scores were lower in Cacicol20 group on day 2 (p= 0.006).
Conclusions
Our results are consistent with our hypothesis that a novel matrix therapy agent (Cacicol 20) facilitates the healing process in the cornea by reconstructing the extracellular matrix in the wound area.