Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-18 | Other Identifier | Gemini Eye Clinics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Manifest refraction Spherical Equivalent | Change in Manifest refraction Spherical Equivalent between baseline and the subsequent follow-up. | Baseline, 1 Month, 6 Months, 1 Year, 2 Years |
| Change in Uncorrected Distance Visual Acuity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with keratoconus grades 1 to 3-4 undergoing corneal cross-linking (CXL) treatment as part of routine clinical care.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41191931 | Derived | Halasova Z, Stodulka P, Skrovinova L, Rakusanova S, Slovak M, Randarova E. Comparison of epithelium-on customized remodeled vision and epithelium-off accelerated crosslinking in keratoconus treatment: 2-year study. J Cataract Refract Surg. 2026 Mar 1;52(3):238-244. doi: 10.1097/j.jcrs.0000000000001805. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
Change in Uncorrected Distance Visual Acuity expressed in logMAR between baseline and the subsequent follow-up.
| Baseline, 1 Month, 6 Months, 1 Year, 2 Years |
| Change in Mean Corneal Curvature Keratometry Kmean | The difference in Kmean values measured between baseline and subsequent follow-up visits | Baseline, 1 Month, 6 Months, 1 Year, 2 Years |
| Change in Corrected Distance Visual Acuity | Change in Corrected Distance Visual Acuity expressed in logMAR between baseline and the subsequent follow-up. | Baseline, 1 Month, 6 Months, 1 Year, 2 Years |
| Change in Thinnest Corneal Thickness | The difference in thinnest corneal thickness between baseline and subsequent follow-up visits | Baseline, 1 Month, 6 Months, 1 Year, 2 Years |