135
Participants
Start Date
January 1, 2016
Primary Completion Date
December 31, 2023
Study Completion Date
March 30, 2024
CuRV CXL
A two-part transepithelial isotonic riboflavin system (ParaCel™ Part 1 and Part 2) was used. Part 1 was applied with a surgical spear and repeated drops, followed by Part 2 instillation for 6 minutes. After rinsing with balanced salt solution, UVA irradiation was performed using the Mosaic® device with Boost Goggles™ delivering supplemental oxygen. Pulsed UVA (365 nm, 30 mW/cm²) was applied in a personalized, three-zone pattern (15 J/cm² to the cone apex, 10 J/cm² to an intermediate annulus, and 7.2 J/cm² to the periphery), guided by Pentacam tomography. A bandage contact lens was placed at the end of the procedure.
Accelerated CXL Procedure (aCXL)
The subjects underwent the aCXL procedure was performed under topical anesthesia after tailored epithelial removal, leaving a small island over the thinnest corneal area. Riboflavin-dextran solution was applied for 30 minutes, followed by UVA irradiation (9 mW/cm², total 5.4 J/cm²) using the KXL device. The cornea was rinsed with Ringer's solution during treatment, and a bandage contact lens was placed afterward.
Gemini Eye Clinic
INDUSTRY