An observational study in Keratoconus, sponsored by Gemini Eye Clinic. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Gemini Eye Clinic · Observational
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.
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 135 is close to the median of 130 across 97 observational studies indexed under Keratoconus.
Browse Keratoconus studies →Gemini Eye Clinic is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Patients with keratoconus grades 1 to 3-4 undergoing corneal cross-linking (CXL) treatment as part of routine clinical care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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)
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.
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 Maximal Corneal Curvature Keratometry Kmax
The difference in Kmax values measured between baseline and subsequent follow-up visits
Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Change in Manifest refraction Spherical Equivalent
Change in Manifest refraction Spherical Equivalent between baseline and the subsequent follow-up.
Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Change in Uncorrected Distance Visual Acuity
Change in Uncorrected Distance Visual Acuity expressed in logMAR between baseline and the subsequent follow-up.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
No study locations are listed for this record.
Ran from Jan 2016 to primary completion in Dec 2023, 95 months.
Of 36 observational studies under Keratoconus, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 95. This study's 95 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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