Keratoconus
Conditions
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.
Interventions
PROCEDURECuRV 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.
PROCEDUREAccelerated 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.
Sponsors
Gemini Eye Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximal Corneal Curvature Keratometry Kmax | Baseline, 1 Month, 6 Months, 1 Year, 2 Years | The difference in Kmax values measured between baseline and subsequent follow-up visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Manifest refraction Spherical Equivalent | Baseline, 1 Month, 6 Months, 1 Year, 2 Years | Change in Manifest refraction Spherical Equivalent between baseline and the subsequent follow-up. |
| Change in Uncorrected Distance Visual Acuity | 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. |
| Change in Mean Corneal Curvature Keratometry Kmean | Baseline, 1 Month, 6 Months, 1 Year, 2 Years | The difference in Kmean values measured between baseline and subsequent follow-up visits |
| Change in Corrected Distance Visual Acuity | 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. |
| Change in Thinnest Corneal Thickness | Baseline, 1 Month, 6 Months, 1 Year, 2 Years | The difference in thinnest corneal thickness between baseline and subsequent follow-up visits |
Outcome results
None listed