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

NCT07173907 | Completed

• 2 other identifiers: CXL20252019-18
• Study Type: observational
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Maximal Corneal Curvature Keratometry Kmax

  The difference in Kmax values measured between baseline and subsequent follow-up visits

  Baseline, 1 Month, 6 Months, 1 Year, 2 Years

Secondary Outcomes (5)

• Change in Manifest refraction Spherical Equivalent

  Baseline, 1 Month, 6 Months, 1 Year, 2 Years

• Change in Uncorrected Distance Visual Acuity

  Baseline, 1 Month, 6 Months, 1 Year, 2 Years

• Change in Mean Corneal Curvature Keratometry Kmean

  Baseline, 1 Month, 6 Months, 1 Year, 2 Years

• Change in Corrected Distance Visual Acuity

  Baseline, 1 Month, 6 Months, 1 Year, 2 Years

• Change in Thinnest Corneal Thickness

  Baseline, 1 Month, 6 Months, 1 Year, 2 Years

Study Arms (2)

CuRV CXL protocol cohort

The subjects underwent the procedure of CuRV method that was performed as an outpatient procedure under topical anesthesia (tetracaine 1%). 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: CuRV CXL

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.

Procedure: Accelerated CXL Procedure (aCXL)

Interventions

CuRV CXL PROCEDURE

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.

CuRV CXL protocol cohort

Accelerated CXL Procedure (aCXL) PROCEDURE

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.

Accelerated CXL Procedure (aCXL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with keratoconus grades 1 to 3-4 undergoing corneal cross-linking (CXL) treatment as part of routine clinical care.

You may qualify if:

• adult eyes
• progressive keratoconus (grades 1 to 3-4, Krumeich-Amsler classification)
• corneal thickness ≥400 μm
• endothelial cell density ≥1500 cells/mm²

You may not qualify if:

• prior corneal surgeries
• corneal scars
• dystrophies
• marginal pellucid degeneration
• systemic connective tissue disorders
• uncontrolled diabetes
• pregnancy, or breastfeeding.

Sponsors & Collaborators

• Gemini Eye Clinic: lead

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: January 1, 2016
• Primary Completion: December 31, 2023
• Study Completion: March 30, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-08