Epi-on CuRV and Epi-off aCXL Protocols in the Management of Keratoconus

CompletedOBSERVATIONAL
Enrollment

135

Participants

Timeline

Start Date

January 1, 2016

Primary Completion Date

December 31, 2023

Study Completion Date

March 30, 2024

Conditions
Keratoconus
Interventions
PROCEDURE

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.

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.

All Listed Sponsors
lead

Gemini Eye Clinic

INDUSTRY

NCT07173907 - Epi-on CuRV and Epi-off aCXL Protocols in the Management of Keratoconus | Biotech Hunter | Biotech Hunter