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NCT Number: NCT07173907

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

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Maximal Corneal Curvature Keratometry Kmax

    Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years

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

Secondary outcomes

  1. Change in Manifest refraction Spherical Equivalent

    Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years

    Change in Manifest refraction Spherical Equivalent between baseline and the subsequent follow-up.

  2. Change in Uncorrected Distance Visual Acuity

    Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years

    Change in Uncorrected Distance Visual Acuity expressed in logMAR between baseline and the subsequent follow-up.

  3. Change in Mean Corneal Curvature Keratometry Kmean

    Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years

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

  4. Change in Corrected Distance Visual Acuity

    Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years

    Change in Corrected Distance Visual Acuity expressed in logMAR between baseline and the subsequent follow-up.

  5. Change in Thinnest Corneal Thickness

    Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years

    The difference in thinnest corneal thickness between baseline and subsequent follow-up visits

Sponsors and collaborators

Lead sponsor

Gemini Eye Clinic

Industry

Registry information

Official study title

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

Acronym: CuRVaCXL

Important dates

Study start
2016
Primary completion
2023
Study completion
2024
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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