NCT07173907

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 135 (actual)
• Sponsor: Gemini Eye Clinic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the effectiveness and safety of two different corneal cross-linking (CXL) protocols for the management of progressive keratoconus: the accelerated epithelium-off technique (aCXL) and the topography-guided epithelium-on Customized Remodeled Vision (CuRV) protocol. These methods differ in their mode of ultraviolet-A (UVA) energy delivery and their approach to corneal surface preservation, with potential implications for both structural stabilization and patient comfort. The primary aim was to evaluate changes in corrected distance visual acuity (CDVA) and maximum keratometry (Kmax) over a 24-month follow-up period, allowing for a direct comparison of visual and topographic outcomes between the two approaches. By assessing these endpoints, the study seeks to address whether epithelium-on, customized cross-linking can achieve similar or improved results compared with conventional accelerated epithelium-off treatment. The findings are intended to provide insights into the relative benefits of standardized versus individualized cross-linking techniques, with the broader goal of optimizing treatment strategies for patients with keratoconus.

Conditions

• Keratoconus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2023-12-31
• Completion: 2024-03-30
• First posted: 2025-09-15
• Last updated: 2025-09-15