KeratoconusNCT02456961
Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin
A study testing iontophoresis of riboflavin, epithelium-off and Corneal collagen crosslinking in people with Keratoconus, run by Ufa Eye Research Institute.
Trial summary
The standard CXL technique involves removal of the epithelium to enable riboflavin to penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- iontophoresis of riboflavin, epithelium-off and Corneal collagen crosslinking
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented progressive KC (by Pentacam and/or corneal topography imaging).
- A clear central cornea.
- A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).
- Minimal Snellen corrected distance visual acuity of ≥ 0.4.
- Patient age of ≥ 18 years.
Who cannot join
- Corneal scarring.
- History of epithelial healing problems.
- History or presence of ocular infection (such as herpes keratitis)
- Pregnancy and/or breastfeeding.
About this study
Official title: Comparative Study of Results of Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin: a Randomized Control Trial
The standard CXL technique involves removal of the epithelium to enable riboflavin to penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis of riboflavin is one of approach for riboflavin impregnation.
In this study, the investigators compared the results of standard corneal crosslinking (CXL) and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up.
- Conditions
- Keratoconus
- Being tested
- iontophoresis of riboflavin, epithelium-off, Corneal collagen crosslinking, galvanizator, Potok-1, Dextralink
- Keywords
- Collagen crosslinking (CXL), Standard corneal crosslinking (CXL), Transepithelial CXL, Iontophoresis, Riboflavin
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iontophoresis of riboflavinProcedure or surgery
epithelium-offProcedure or surgery
Corneal collagen crosslinkingProcedure or surgery
Standard surface UVA irradiation (370 nm, 3 mW/cm2; UFalink, Russian Federation) was then applied at a 5-cm distance for 30 minutes. During UVA exposure, hypotonic riboflavin drops were continued every 2 minutes.
galvanizator, Potok-1Device
Device for providing iontophoresis procedure
DextralinkDrug
Riboflavin 0,1% + Dextran T-500
Riboflavin 0,1%Drug
UFalinkDevice
device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2
| Study group | Role | What they receive |
|---|---|---|
| Standard epithelium-off CXL | Active comparator | Removing the central 8-10mm of the epithelium and applying a riboflavin solution (0.1% riboflavin-5-phosphate and 20% dextran T-500) to the corneal surface 30 minutes before irradiation and at 5 minutes intervals during the course of a 30 minute exposure to 370 nm UVA with an irradiance of 3 mWcm-2 (UFalink, Russian Federation) Receives: Procedure: epithelium-off; Procedure: Corneal collagen crosslinking; Drug: Dextralink; Device: UFalink |
| Transepithelial CXL via iontophoresis of riboflavin | Experimental | impregnation of the cornea with a riboflavin 0.1% hypotonic solution is performed by using an iontophoresis device (galvanizator; Potok-1, Russian Federation). The passive electrode (anode) was applied to the inferior part of the cervical vertebrae. The active electrode (cathode), a bath tube (glass or plastic - 10-12 ml) is applied to the open eye,then r the tube is taped to the skin of the orbital margins and filled with riboflavin 0.1%. The current intensity is initially 0.2 mA and then gradually increased to 1.0 mA at 0.2 mA for 1 minute at 10-second intervals increments to determine individual tolerance. The total time that the riboflavin administration is 10 minutes.
Standard surface UVA irradiation (370 nm, 3 mW/cm2) using UFalink device, (Russian Federation) is then applied at a 5-cm distance for 30 minutes with continuing hypotonic riboflavin drops every 2 minutes Receives: Procedure: iontophoresis of riboflavin; Procedure: Corneal collagen crosslinking; Device: galvanizator, Potok-1; Drug: Riboflavin 0,1%; Device: UFalink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kmax, D
Using topography measurements, clinical stabilisation is defined as an increase of no more than 1 diopter of the maximum keratometry value over the preoperative maximum keratometry value
Measured: 2 years
Secondary outcomes (2)
Corneal thickness, μm, as measured by OCT tomography
Using optical coherence tomography to estimate the pachymetry changes
Measured: 2 years
Visual acuity as assessed by Decimal system
Decimal visual acuity assessed on a study later was converted to the logarithm of minimal angle of resolution (logMAR).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJan 2010
- Primary completionDec 2014
- Study completionDec 2014
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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ufa Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mukharram Bikbov, Professor, Study chair, Ufa Eye Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456961
- Sponsor's protocol ID
- TCXL-ionto
- Status last verified
- May 2015
- First submitted
- 20 May 2015
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Results of Standard Corneal Collagen Crosslinking Versus Transepithelial Corneal Crosslinking by Iontophoresis of Riboflavin: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02456961
- Acronym / sponsor ID
- TCXL-ionto
- Conditions
- Keratoconus
- Keywords
- Collagen crosslinking (CXL), Standard corneal crosslinking (CXL), Transepithelial CXL, Iontophoresis, Riboflavin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ufa Eye Research InstituteUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 May 2015 (estimated)
- 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.
The standard CXL technique involves removal of the epithelium to enable riboflavin to penetrate into stromal tissue, to avoid epithelial debridement and increasing the patient's comfort and safety transepithelial corneal crosslinking (CXL) was suggested. Iontophoresis of riboflavin is one of approach for riboflavin impregnation.
In this study, the investigators compared the results of standard corneal crosslinking (CXL) and transepithelial CXL via iontophoresis of riboflavin after 24 months follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard epithelium-off CXL | Active comparator | Procedure: epithelium-off, Procedure: Corneal collagen crosslinking, Drug: Dextralink, Device: UFalinkRemoving the central 8-10mm of the epithelium and applying a riboflavin solution (0.1% riboflavin-5-phosphate and 20% dextran T-500) to the corneal surface 30 minutes before irradiation and at 5 minutes intervals during the course of a 30 minute exposure to 370 nm UVA with an irradiance of 3 mWcm-2 (UFalink, Russian Federation) |
| Transepithelial CXL via iontophoresis of riboflavin | Experimental | Procedure: iontophoresis of riboflavin, Procedure: Corneal collagen crosslinking, Device: galvanizator, Potok-1, Drug: Riboflavin 0,1%, Device: UFalinkimpregnation of the cornea with a riboflavin 0.1% hypotonic solution is performed by using an iontophoresis device (galvanizator; Potok-1, Russian Federation). The passive electrode (anode) was applied to the inferior part of the cervical vertebrae. The active electrode (cathode), a bath tube (glass or plastic - 10-12 ml) is applied to the open eye,then r the tube is taped to the skin of the orbital margins and filled with riboflavin 0.1%. The current intensity is initially 0.2 mA and then gradually increased to 1.0 mA at 0.2 mA for 1 minute at 10-second intervals increments to determine individual tolerance. The total time that the riboflavin administration is 10 minutes. Standard surface UVA irradiation (370 nm, 3 mW/cm2) using UFalink device, (Russian Federation) is then applied at a 5-cm distance for 30 minutes with continuing hypotonic riboflavin drops every 2 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented progressive KC (by Pentacam and/or corneal topography imaging).
- A clear central cornea.
- A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).
- Minimal Snellen corrected distance visual acuity of ≥ 0.4.
- Patient age of ≥ 18 years.
Key exclusion criteria (4 listed)
- Corneal scarring.
- History of epithelial healing problems.
- History or presence of ocular infection (such as herpes keratitis)
- Pregnancy and/or breastfeeding.
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 |
|---|---|---|
| iontophoresis of riboflavin | Procedure or surgery | Transepithelial CXL via iontophoresis of riboflavin |
| epithelium-off | Procedure or surgery | Standard epithelium-off CXL |
| Corneal collagen crosslinkingStandard surface UVA irradiation (370 nm, 3 mW/cm2; UFalink, Russian Federation) was then applied at a 5-cm distance for 30 minutes. During UVA exposure, hypotonic riboflavin drops were continued every 2 minutes. | Procedure or surgery | Standard epithelium-off CXL, Transepithelial CXL via iontophoresis of riboflavin |
| galvanizator, Potok-1Device for providing iontophoresis procedure | Device | Transepithelial CXL via iontophoresis of riboflavin |
| DextralinkRiboflavin 0,1% + Dextran T-500 | Drug | Standard epithelium-off CXL |
| Riboflavin 0,1% | Drug | Transepithelial CXL via iontophoresis of riboflavin |
| UFalinkdevice for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2 | Device | Standard epithelium-off CXL, Transepithelial CXL via iontophoresis of riboflavin |
Primary outcome
Kmax, D
Time frame: 2 years
Using topography measurements, clinical stabilisation is defined as an increase of no more than 1 diopter of the maximum keratometry value over the preoperative maximum keratometry value
2 secondary outcomes
Corneal thickness, μm, as measured by OCT tomography
Time frame: 2 years
Visual acuity as assessed by Decimal system
Time frame: 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 29 May 2015.
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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.
Mukharram Bikbov, Professor study chair
Ufa Eye Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing iontophoresis of riboflavin, epithelium-off and Corneal collagen crosslinking in people with Keratoconus, run by Ufa Eye Research Institute.
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 5 inclusion and 4 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 29 May 2015. 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?
Kmax, D (time frame: 2 years). 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 29 May 2015.