KeratoconusNCT02349165
Standard Versus Transepithelial Corneal Crosslinking
A study testing Transepithelial versus epithelium-off CXL, Ricrolin TE and Isotonic riboflavin in people with Keratoconus, run by Nienke Soeters at 1 site in Netherlands.
Trial summary
The gold standard corneal crosslinking (CXL) technique involves the initial step of epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation of progressive keratoconus (KC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Transepithelial versus epithelium-off CXL, Ricrolin TE and Isotonic riboflavin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to Sep 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.
- For this research study, the inclusion parameters will be the same as mentioned above, with the following additional inclusion criteria:
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- Documented progression of KC, as demonstrated by anterior segment imaging and/or corneal topography:
- o Defined an increase in maximal keratometry, steepest keratometry, mean keratometry or topographic cylinder value by ≥ 0.5 D over the previous 6 months and/or a decrease in thinnest pachymetry
- Documented progression of KC defined by increase in refractive cylinder of ≥ 0.5 D over the previous 6 months
Who cannot join
- Presence of corneal scars.
- History of epithelial healing problems.
- Presence of previous ocular infection (such as herpes keratitis).
- Patients who are pregnant and/or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
About this study
Official title: Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus
The gold standard corneal crosslinking (CXL) technique involves the initial step of epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation of progressive keratoconus (KC). Our aim is to evaluate the effects of transepithelial CXL (TE-CXL), whereby the epithelium is left intact and the cornea is instead treated by a solution composed of 0.1% riboflavin, combined with enhancers, after which standard CXL is performed. This solution seems to facilitate riboflavin penetration into the corneal stroma through the intact epithelium. The investigators expect to achieve a similar effect of TE-CXL with the advantage of a faster healing time and less risk of infections.
- Conditions
- Keratoconus
- Being tested
- Transepithelial versus epithelium-off CXL, Ricrolin TE, Isotonic riboflavin
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transepithelial versus epithelium-off CXLProcedure or surgery
Also called epithelium-on versus epithelium-ff corneal crosslinking
A comparison of the CXL procedure with and without epithelium removal
Ricrolin TEDrug
Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation
Isotonic riboflavinDrug
After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation
| Study group | Role | What they receive |
|---|---|---|
| epithelium off CXL | Active comparator | epithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes) Receives: Procedure: Transepithelial versus epithelium-off CXL; Drug: Isotonic riboflavin |
| Ricrolin TE CXL | Experimental | Ricrolin-TE eye drops for 15 minutes (2 minute interval) and 15 minute Ricrolin TE pooled on the cornea using a silicone ring + 30 minutes ultraviolet-A irradiation (Ricrolin TE every 5 minutes). Receives: Procedure: Transepithelial versus epithelium-off CXL; Drug: Ricrolin TE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical stabilisation of keratoconus one year after CXL
Using a Scheimpflug device (Pentacam, Oculus), topography measurements are performed. 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: 1 year
Secondary outcomes (1)
Complications, defined as epithelial healing problems and/or keratitis.
the incidence of epithelial healing problems after treatment will be recorded
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startMay 2011
- Primary completionSep 2014
- Study completionSep 2014
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nienke Soeters
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. F.P. Fischer Stichting, Stichting Nederlands Oogheelkundig Onderzoek
- Responsible party
- Sponsor-investigator, Nienke Soeters, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349165
- Sponsor's protocol ID
- NL29961
- Other IDs
- 10-374
- Status last verified
- Jan 2015
- First submitted
- 17 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
PubMed 32557558
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus
- ClinicalTrials.gov ID
- NCT02349165
- Acronym / sponsor ID
- NL29961
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Nienke SoetersUniversity, hospital or other
- Collaborators
- Dr. F.P. Fischer Stichting, Stichting Nederlands Oogheelkundig Onderzoek
- Study start
- May 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 28 Jan 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 gold standard corneal crosslinking (CXL) technique involves the initial step of epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation of progressive keratoconus (KC). Our aim is to evaluate the effects of transepithelial CXL (TE-CXL), whereby the epithelium is left intact and the cornea is instead treated by a solution composed of 0.1% riboflavin, combined with enhancers, after which standard CXL is performed. This solution seems to facilitate riboflavin penetration into the corneal stroma through the intact epithelium. The investigators expect to achieve a similar effect of TE-CXL with the advantage of a faster healing time and less risk of infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epithelium off CXL | Active comparator | Procedure: Transepithelial versus epithelium-off CXL, Drug: Isotonic riboflavinepithelium removal + 30 minute isotonic riboflavin eye drops (3 minute interval) + 30 minutes ultraviolet-A irradiation (riboflavin every 5 minutes) |
| Ricrolin TE CXL | Experimental | Procedure: Transepithelial versus epithelium-off CXL, Drug: Ricrolin TERicrolin-TE eye drops for 15 minutes (2 minute interval) and 15 minute Ricrolin TE pooled on the cornea using a silicone ring + 30 minutes ultraviolet-A irradiation (Ricrolin TE every 5 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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)
- Presence of corneal scars.
- History of epithelial healing problems.
- Presence of previous ocular infection (such as herpes keratitis).
- Patients who are pregnant 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 |
|---|---|---|
| Transepithelial versus epithelium-off CXLAlso: epithelium-on versus epithelium-ff corneal crosslinkingA comparison of the CXL procedure with and without epithelium removal | Procedure or surgery | Ricrolin TE CXL, epithelium off CXL |
| Ricrolin TERicrolin TE was instilled during 30 minutes before ultraviolet-A irradiation | Drug | Ricrolin TE CXL |
| Isotonic riboflavinAfter epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation | Drug | epithelium off CXL |
Primary outcome
Clinical stabilisation of keratoconus one year after CXL
Time frame: 1 year
Using a Scheimpflug device (Pentacam, Oculus), topography measurements are performed. Clinical stabilisation is defined as an increase of no more than 1 diopter of the maximum keratometry value over the preoperative maximum keratometry value.
1 secondary outcome
Complications, defined as epithelial healing problems and/or keratitis.
Time frame: 1 year
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 28 Jan 2015.
- Derived from this study: PubMed 32557558Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transepithelial versus epithelium-off CXL, Ricrolin TE and Isotonic riboflavin in people with Keratoconus, run by Nienke Soeters at 1 site in Netherlands.
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 9 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 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Clinical stabilisation of keratoconus one year after CXL (time frame: 1 year). 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 NCT02349165, 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 28 Jan 2015.