KeratoconusNCT03598634
Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients
A study testing administration of riboflavin for epi-off cross-linking and administration of riboflavin for epi-on cross-linking in people with Keratoconus, run by University of Molise.
Trial summary
To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- administration of riboflavin for epi-off cross-linking and administration of riboflavin for epi-on cross-linking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 31 Dec 2017
- Phase
- Interventional
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with evolving keratoconus
- aged between 18 and 40 years
- no evidence of corneal scarring
Who cannot join
- patients with central and paracentral corneal opacities
- Vogt's striae
- previous intraocular surgery
- history of herpetic keratitis
- history of severe dry eye
- concomitant autoimmune diseases.
About this study
Official title: Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients: a Comparative Study Throught 2 Years Follow-up
To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.
Read the detailed description
The aim of the study is to evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.
Forty eyes from 32 patients with progressive keratoconus were prospectively enrolled from June 2014 to June 2015 in this non-blinded, randomized comparative study. Twenty eyes were treated by CXL epi off and 20 by CLX epi on, randomly assigned and followed for 2 years. All patients underwent a complete ophthalmologic testing that included uncorrected and best corrected visual acuity, central and peripheral corneal thickness, corneal astigmatism, simulated maximum, minimum, and average keratometry, corneal confocal microscopy, Schirmer I and break-up time (BUT) tests, and the Ocular Surface Disease Index. Intra-and postoperative complications were recorded. The solution used for CXL epi off comprised riboflavin 0.1% and dextran 20.0% (Ricrolin), whereas the solution for CXL epi on (Ricrolin, TE) comprised riboflavin 0.1%, dextran 15.0%, trometamol (Tris), and ethylene-diamine-tetra-acetic acid. Ultraviolet-A treatment was performed with UV-X System at 3 mW/cm2.
- Conditions
- Keratoconus
- Being tested
- administration of riboflavin for epi-off cross-linking, administration of riboflavin for epi-on cross-linking
- Keywords
- cross-linking
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of riboflavin for epi-off cross-linkingProcedure or surgery
riboflavin 0.1% in 20% dextran solution
administration of riboflavin for epi-on cross-linkingProcedure or surgery
riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid
| Study group | Role | What they receive |
|---|---|---|
| Epi-on cross-linking | Active comparator | Intervention: Drug: Riboflavin 0.15 in 20% dextran solution Receives: Procedure: administration of riboflavin for epi-off cross-linking; Procedure: administration of riboflavin for epi-on cross-linking |
| Epi-off cross-linking | Active comparator | intervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid Receives: Procedure: administration of riboflavin for epi-off cross-linking; Procedure: administration of riboflavin for epi-on cross-linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected visual acuity after treatment
- Scale name: Early treatment diabetic retinopathy study (ETDRS) charts.
- Scale range 0-1.
- highest value of the range (corresponding to 20/20): 0
- lowest value of the range (corresponding to 20/200): 1
Measured: up to 48 months from the recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Jun 2014
- Primary completion30 Jun 2015
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciro Costagliola, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598634
- Sponsor's protocol ID
- 0001-05-2018
- Status last verified
- Jul 2018
- First submitted
- 12 Jun 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available once the studies results will be published
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients: a Comparative Study Throught 2 Years Follow-up
- ClinicalTrials.gov ID
- NCT03598634
- Acronym / sponsor ID
- 0001-05-2018
- Conditions
- Keratoconus
- Keywords
- cross-linking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 Jul 2018 (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.
To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.
Detailed description
The aim of the study is to evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.
Forty eyes from 32 patients with progressive keratoconus were prospectively enrolled from June 2014 to June 2015 in this non-blinded, randomized comparative study. Twenty eyes were treated by CXL epi off and 20 by CLX epi on, randomly assigned and followed for 2 years. All patients underwent a complete ophthalmologic testing that included uncorrected and best corrected visual acuity, central and peripheral corneal thickness, corneal astigmatism, simulated maximum, minimum, and average keratometry, corneal confocal microscopy, Schirmer I and break-up time (BUT) tests, and the Ocular Surface Disease Index. Intra-and postoperative complications were recorded. The solution used for CXL epi off comprised riboflavin 0.1% and dextran 20.0% (Ricrolin), whereas the solution for CXL epi on (Ricrolin, TE) comprised riboflavin 0.1%, dextran 15.0%, trometamol (Tris), and ethylene-diamine-tetra-acetic acid. Ultraviolet-A treatment was performed with UV-X System at 3 mW/cm2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epi-on cross-linking | Active comparator | Procedure: administration of riboflavin for epi-off cross-linking, Procedure: administration of riboflavin for epi-on cross-linkingIntervention: Drug: Riboflavin 0.15 in 20% dextran solution |
| Epi-off cross-linking | Active comparator | Procedure: administration of riboflavin for epi-off cross-linking, Procedure: administration of riboflavin for epi-on cross-linkingintervention: Drug: Riboflavin 0.15 in 15% dextran solution supplemented with Tris-hydroxymethylaminomethane and sodium ethylenediaminetetraacetic acid |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients with evolving keratoconus
- aged between 18 and 40 years
- no evidence of corneal scarring
Key exclusion criteria (6 listed)
- patients with central and paracentral corneal opacities
- Vogt's striae
- previous intraocular surgery
- history of herpetic keratitis
- history of severe dry eye
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 |
|---|---|---|
| administration of riboflavin for epi-off cross-linkingriboflavin 0.1% in 20% dextran solution | Procedure or surgery | Epi-off cross-linking, Epi-on cross-linking |
| administration of riboflavin for epi-on cross-linkingriboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid | Procedure or surgery | Epi-off cross-linking, Epi-on cross-linking |
Primary outcome
Best-corrected visual acuity after treatment
Time frame: up to 48 months from the recruitment
* Scale name: Early treatment diabetic retinopathy study (ETDRS) charts. * Scale range 0-1. * highest value of the range (corresponding to 20/20): 0 * lowest value of the range (corresponding to 20/200): 1
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 26 Jul 2018.
- Individual participant dataSharing planned: Undecided. Data will be made available once the studies results will be published
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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?
A study testing administration of riboflavin for epi-off cross-linking and administration of riboflavin for epi-on cross-linking in people with Keratoconus, run by University of Molise.
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 3 inclusion and 6 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 26 Jul 2018. 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?
Best-corrected visual acuity after treatment (time frame: up to 48 months from the recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2018.