KeratoconusTE-CXLNCT03584243
Transepithelial Corneal Collagen Crosslinking in Eyes With Progressive Keratoconus
A study testing A crosslinking with oxygen treatment in people with Keratoconus, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Keratoconus is a corneal ectatic disease responsible for a loss of visual acuity when the steepening increases. Corneal collagen crosslinking (CXL) is a procedure that appears to halt or slow down the progression and avoid the visual impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- A crosslinking with oxygen treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2017to Jun 2019
- 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
- Be at least 18 years of age
- Provide written informed consent
- Diagnosis of progressive keratoconus
- Best corrected visual acuity between 0,05 and 1 decimal scale
- Willingness to follow all instructions and comply with schedule for follow-up visits.
- Social security insurance or equivalent.
Who cannot join
- Hypersensitivity to local treatment
- Corneal pachymetry < 400 μm
- Non progressive keratoconus
- Aphakic eye or eye with cataract implant without UV filter
- Concomitant corneal disease
- History of corneal surgery
Show all 9Show fewer
- History of crosslinking treatment
- Pregnancy or lactation
- Juridical protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficiency and Security of Transepithelial Corneal Collagen Crosslinking With Oxygen to Treat Progressive Keratoconus.
Keratoconus is a corneal ectatic disease responsible for a loss of visual acuity when the steepening increases. Corneal collagen crosslinking (CXL) is a procedure that appears to halt or slow down the progression and avoid the visual impairment. However, such a technique requires the epithelium debridement, wich can be responsible for severs complications.
This study evaluate the safety and efficacy of transepithelial corneal crosslinking with oxygen to halt or slow down the progression of keratoconus. Such a procedure avoids the epithelium debridement and the related complications.
Read the detailed description
Keratoconus is a common bilateral progressive corneal ectatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. This disorder typically begins during teenage years. Patients with severe forms may need a corneal transplantation. The CXL procedure, described in 1998, allows to halt or to slow down the disease progression and may avoid other surgeries, e.g. transplantation. This technique creates links between collagen fibrils in order to rigidify the corneal stroma. The corneal stroma is soaked with a riboflavin solution (vitamin B2) before being exposed to ultraviolet-A (UVA) radiations. In the current standard CXL, the central corneal epithelium must be debrided to allow the penetration of riboflavin into the cornea, with a risk of side effects, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, and serious complications such as infections and stromal opacity due to corneal scarring Transepithelial crosslinking is a non-invasive technique in which benzalkonium chloride is used to enhance the penetration of riboflavin into the cornea. To improve the reaction, a device provides oxygen to the corneal surface. The transepithelial technique could allow intrastromal riboflavin diffusion, while keeping the corneal epithelium on, conserving the efficiency of the standard procedure without the complications induced by epithelial debridement.
Patient with progressive keratoconus will be included and treated with the transepithelial procedure. The follow-up will last for one year. Every follow-up visit will evaluate the security of the procedure and its efficacy to stop or slow down the progression of the disease. Interrogatory and slit lamp examination will be performed to investigate the potential adverse effects of the procedure.
- Conditions
- Keratoconus
- Being tested
- A crosslinking with oxygen treatment
- Keywords
- collagen crosslinking, transepithelial crosslinking
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A crosslinking with oxygen treatmentProcedure or surgery
A supplemental oxygen system during the cross linking will be used to apply filtered, humidified oxygen across the surface of the eye through a mask. The oxygen flow will be turned on immediately prior to initiation of irradiation, and will continue through the irradiation period. The supplemental oxygen flow will be shut off following completion of the programmed irradiation time.
All subjects will be evaluated at screening, day 3, and 1, 3, 6, 12 and 24 months after treatment. At the same time all the potential adverse effects will be relieved.
| Study group | Role | What they receive |
|---|---|---|
| Patient with progressive keratoconus | Experimental | Patient with progressive keratoconus will be included after providing their consent.
The intervention administrated is a cross-linking with oxygen treatment Receives: Procedure: A crosslinking with oxygen treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the transepithelial crosslinking method
The non-comparative evaluation of the efficacy of crosslinking of transepithelial corneal collagen with oxygen in the stabilization of progressive keratoconus during 12 months of follow-up.
- Change from pretreatment baseline : keratometry at one year.
Measured: One year
Efficacy of the transepithelial crosslinking method
The non-comparative evaluation of the efficacy of crosslinking of transepithelial corneal collagen with oxygen in the stabilization of progressive keratoconus during 12 months of follow-up.
- Change from pretreatment in manifest refraction spherical equivalent at one year.
Measured: One year
Efficacy of the transepithelial crosslinking method
- Change from pretreatment baseline : best corrected/uncorrected visual acuity at one year
Measured: One year
Secondary outcomes (4)
Security of the transepithelial crosslinking
The non-comparative evaluation of the safety of crosslinking of transepithelial corneal collagen with oxygen in the stabilization of progressive keratoconus during 12 months of follow-up.
- Change from pretreatment baseline : intraocular pressure at one year.
Measured: One year
Security of the transepithelial crosslinking
The non-comparative evaluation of the safety of crosslinking of transepithelial corneal collagen with oxygen in the stabilization of progressive keratoconus during 12 months of follow-up.
- Change from baseline in endothelial cell count at one year.
Measured: One year
Incidence and security of the transepithelial crosslinking
- Incidence of treatment emergent ocular adverse events reported during the study.
Measured: One year
Incidence and security of the transepithelial crosslinking
- Percentage of eyes with loss in best corrected of three lines from pretreatment baseline.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start21 Dec 2017
- Primary completionSep 2018 (estimated)
- Study completionJun 2019 (estimated)
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.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This experimental study is a prospective, one-center city and non-comparative study. Patient with progressive keratoconus will be included after providing their consent. The intervention of the study is to perform transepithelial crosslinking with oxygen Outcomes will be evaluated from pretreatment baseline of the patient.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Malecaze, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584243
- Sponsor's protocol ID
- RC31/17/0338
- Other IDs
- 2017-A02661-52
- Acronym
- TE-CXL
- Status last verified
- Jul 2018
- First submitted
- 26 Feb 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficiency and Security of Transepithelial Corneal Collagen Crosslinking With Oxygen to Treat Progressive Keratoconus.
- ClinicalTrials.gov ID
- NCT03584243
- Acronym / sponsor ID
- TE-CXL / RC31/17/0338
- Conditions
- Keratoconus
- Keywords
- collagen crosslinking, transepithelial crosslinking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 12 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.
Keratoconus is a corneal ectatic disease responsible for a loss of visual acuity when the steepening increases. Corneal collagen crosslinking (CXL) is a procedure that appears to halt or slow down the progression and avoid the visual impairment. However, such a technique requires the epithelium debridement, wich can be responsible for severs complications.
This study evaluate the safety and efficacy of transepithelial corneal crosslinking with oxygen to halt or slow down the progression of keratoconus. Such a procedure avoids the epithelium debridement and the related complications.
Detailed description
Keratoconus is a common bilateral progressive corneal ectatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. This disorder typically begins during teenage years. Patients with severe forms may need a corneal transplantation. The CXL procedure, described in 1998, allows to halt or to slow down the disease progression and may avoid other surgeries, e.g. transplantation. This technique creates links between collagen fibrils in order to rigidify the corneal stroma. The corneal stroma is soaked with a riboflavin solution (vitamin B2) before being exposed to ultraviolet-A (UVA) radiations. In the current standard CXL, the central corneal epithelium must be debrided to allow the penetration of riboflavin into the cornea, with a risk of side effects, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, and serious complications such as infections and stromal opacity due to corneal scarring Transepithelial crosslinking is a non-invasive technique in which benzalkonium chloride is used to enhance the penetration of riboflavin into the cornea. To improve the reaction, a device provides oxygen to the corneal surface. The transepithelial technique could allow intrastromal riboflavin diffusion, while keeping the corneal epithelium on, conserving the efficiency of the standard procedure without the complications induced by epithelial debridement.
Patient with progressive keratoconus will be included and treated with the transepithelial procedure. The follow-up will last for one year. Every follow-up visit will evaluate the security of the procedure and its efficacy to stop or slow down the progression of the disease. Interrogatory and slit lamp examination will be performed to investigate the potential adverse effects of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This experimental study is a prospective, one-center city and non-comparative study. Patient with progressive keratoconus will be included after providing their consent. The intervention of the study is to perform transepithelial crosslinking with oxygen Outcomes will be evaluated from pretreatment baseline of the patient.
| Arm | Type | Receives |
|---|---|---|
| Patient with progressive keratoconus | Experimental | Procedure: A crosslinking with oxygen treatmentPatient with progressive keratoconus will be included after providing their consent. The intervention administrated is a cross-linking with oxygen treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 18 years of age
- Provide written informed consent
- Diagnosis of progressive keratoconus
- Best corrected visual acuity between 0,05 and 1 decimal scale
- Willingness to follow all instructions and comply with schedule for follow-up visits.
Key exclusion criteria (9 listed)
- Hypersensitivity to local treatment
- Corneal pachymetry < 400 μm
- Non progressive keratoconus
- Aphakic eye or eye with cataract implant without UV filter
- Concomitant corneal disease
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 |
|---|---|---|
| A crosslinking with oxygen treatmentA supplemental oxygen system during the cross linking will be used to apply filtered, humidified oxygen across the surface of the eye through a mask. The oxygen flow will be turned on immediately prior to initiation of irradiation, and will continue through the irradiation period. The supplemental oxygen flow will be shut off following completion of the programmed irradiation time. All subjects will be evaluated at screening, day 3, and 1, 3, 6, 12 and 24 months after treatment. At the same time all the potential adverse effects will be relieved. | Procedure or surgery | Patient with progressive keratoconus |
Primary outcome
Efficacy of the transepithelial crosslinking method
Time frame: One year
The non-comparative evaluation of the efficacy of crosslinking of transepithelial corneal collagen with oxygen in the stabilization of progressive keratoconus during 12 months of follow-up. - Change from pretreatment baseline : keratometry at one year.
Efficacy of the transepithelial crosslinking method
Time frame: One year
The non-comparative evaluation of the efficacy of crosslinking of transepithelial corneal collagen with oxygen in the stabilization of progressive keratoconus during 12 months of follow-up. - Change from pretreatment in manifest refraction spherical equivalent at one year.
Efficacy of the transepithelial crosslinking method
Time frame: One year
- Change from pretreatment baseline : best corrected/uncorrected visual acuity at one year
4 secondary outcomes
Security of the transepithelial crosslinking
Time frame: One year
Security of the transepithelial crosslinking
Time frame: One year
Incidence and security of the transepithelial crosslinking
Time frame: One year
Incidence and security of the transepithelial crosslinking
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Individual participant dataSharing planned: No
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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.
François Malecaze, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A crosslinking with oxygen treatment in people with Keratoconus, run by University Hospital, Toulouse at 1 site in France.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Jul 2018. 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 France. 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?
Results are not available in the source record.
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?
Efficacy of the transepithelial crosslinking method (time frame: One year). The study lists 3 primary outcomes in all. 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 12 Jul 2018.