KeratoconusCuRVaCXLNCT07173907
Epi-on CuRV and Epi-off aCXL Protocols in the Management of Keratoconus
An observational study of Keratoconus, run by Gemini Eye Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- CuRV CXL and Accelerated CXL Procedure (aCXL)
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with keratoconus grades 1 to 3-4 undergoing corneal cross-linking (CXL) treatment as part of routine clinical care.
Who may be able to join
- adult eyes
- progressive keratoconus (grades 1 to 3-4, Krumeich-Amsler classification)
- corneal thickness ≥400 μm
- endothelial cell density ≥1500 cells/mm²
Who cannot join
- prior corneal surgeries
- corneal scars
- dystrophies
- marginal pellucid degeneration
- systemic connective tissue disorders
- uncontrolled diabetes
- pregnancy, or breastfeeding.
About this study
Official title: Comparison of Epithelium-on CuRV and Epithelium-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.
- Conditions
- Keratoconus
- Being tested
- CuRV CXL, Accelerated CXL Procedure (aCXL)
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CuRV CXLProcedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Accelerated CXL Procedure (aCXL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Corneal Curvature Keratometry Kmax
The difference in Kmax values measured between baseline and subsequent follow-up visits
Measured: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Secondary outcomes (5)
Change in Manifest refraction Spherical Equivalent
Change in Manifest refraction Spherical Equivalent between baseline and the subsequent follow-up.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start1 Jan 2016
- Primary completion31 Dec 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gemini Eye Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Pavel Stodulka, Gemini Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173907
- Sponsor's protocol ID
- CXL2025
- Other IDs
- 2019-18
- Acronym
- CuRVaCXL
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41191931
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epithelium-on CuRV and Epithelium-off aCXL Protocols in the Management of Keratoconus
- ClinicalTrials.gov ID
- NCT07173907
- Acronym / sponsor ID
- CuRVaCXL / CXL2025
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Gemini Eye ClinicIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CuRV CXL protocol cohort | – | Procedure: CuRV CXLThe 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) | – | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with keratoconus grades 1 to 3-4 undergoing corneal cross-linking (CXL) treatment as part of routine clinical care.
Key inclusion criteria (4 listed)
- adult eyes
- progressive keratoconus (grades 1 to 3-4, Krumeich-Amsler classification)
- corneal thickness ≥400 μm
- endothelial cell density ≥1500 cells/mm²
Key exclusion criteria (7 listed)
- prior corneal surgeries
- corneal scars
- dystrophies
- marginal pellucid degeneration
- systemic connective tissue disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CuRV CXLA 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 or surgery | CuRV CXL protocol cohort |
| 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 or surgery | Accelerated CXL Procedure (aCXL) |
Primary outcome
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
5 secondary outcomes
Change in Manifest refraction Spherical Equivalent
Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Change in Uncorrected Distance Visual Acuity
Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Change in Mean Corneal Curvature Keratometry Kmean
Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Change in Corrected Distance Visual Acuity
Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Change in Thinnest Corneal Thickness
Time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 41191931Halasova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Gemini Eye Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximal Corneal Curvature Keratometry Kmax (time frame: Baseline, 1 Month, 6 Months, 1 Year, 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07173907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.