Comparison of clinical results of two pharmaceutical products of riboflavin in corneal collagen cross-linking for keratoconus

Background

To compare the 6-month results of two formulations of Riboflavin provided by Sina Darou, Iran, and Uznach, Switzerland, in corneal collagen cross-linking (CXL) for keratoconus patients.

Findings

Considering the results of the previous study about the similarity of the formulations and the active ingredients of the two types of Riboflavin, they were used in the CXL procedure of 60 keratoconic eyes (30 eyes in each group). After 6 months, the mean improvement of UCVA (0.239), BCVA (0.707), and MRSE (0.513) did not differ significantly between the two groups. The mean decrease in max- K (0.731), mean- K (0.264), central corneal thickness (0.759), and Q-value (0.669) did not show any significant difference between the two groups. The two groups had no significant difference in endothelial cell count decrease (0.229). The Sina Darou formulation decreased corneal hysteresis more than the Swiss formulation (P = 0.057) but there were no significant differences in the mean decrease of corneal resistance factor between the two groups (P = 0.117).

Conclusions

Based on the early results, the results of visual acuity, refraction, and corneal topography using Sina Darou and Uznach formulations of Riboflavin showed that both were effective in CXL. However, considering the relatively significant difference in corneal hysteresis changes between the two groups, this study will continue to report the long-term results.