The study was done to evaluate the clinical results of KeraVio in patients with progressive corneal ectasia.
Eyes were exposed to VL (375 nm, irradiance 310 μW/cm2)-emitting glasses for 3 hours daily for 6 months, and a riboflavin solution was administered into the corneal epithelium six times during each 3-hour VL irradiation. The primary endpoint was a change in the maximum keratometry (Kmax) value over 6 months compared with that over the 1 year before baseline.
The efficacy of KeraVio was evaluated in 20 eyes with severe progression, and its safety was evaluated in all 40 eyes. The mean changes in Kmax over the 1 year before baseline and during the 6-month observation period were 6.03±3.41 dioptres (D) and −0.81±3.34 D, respectively (p=0.002). At 6 months, the Kmax value decreased by more than 2 D in 20%, remained within 2 D in 65%, and increased by 2 D or more in 3 eyes (15%). The corneal stromal demarcation line was identified in 80%, and its depth was 206.3±54.9 μm at 1 month. No significant decrease in endothelial cell density, lenticular opacity or transient corneal haze was noted.
The study concluded that daily treatment of progressive corneal ectasia with KeraVio can halt disease progression without any safety concerns.