A Multicenter, Randomized, Double-Masked, Sham-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-on Corneal Crosslinking in Keratoconus Subjects 8 to 45 Years of Age: Baseline Endothelial Studies | Synapse
April 12, 2026
A Multicenter, Randomized, Double-Masked, Sham-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-on Corneal Crosslinking in Keratoconus Subjects 8 to 45 Years of Age: Baseline Endothelial Studies
Key Points
To evaluate the efficacy and safety of epithelium-on corneal crosslinking in individuals with keratoconus.
Conducted a multicenter randomized phase 3 trial
Included subjects aged 8 to 45 with diagnosed keratoconus
Implemented sham-controlled and double-masked study design
Analyzed baseline endothelial studies to assess impact on ECD
As keratoconus severity increases, endothelial cell density (ECD) significantly decreases
Even in advanced keratoconus stages, ECD values remain within a physiological range
Abstract
Increasing keratoconus tomographic severity results in a significant decrease in ECD. However, even in the most advanced stages, the ECD remains within physiological range.