KeratoconusPhase 2NCT04811924

The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients

A Phase 2 study testing Application of 0.02% MMC over 60 seconds post corneal crosslinking. and Corneal crosslinking without the application of 0.02% MMC in people with Keratoconus, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Keratoconus
What is being tested?: Application of 0.02% MMC over 60 seconds post corneal crosslinking. and Corneal crosslinking without the application of 0.02% MMC
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4 participants
Where: 1 siteCanada
Study dates: 26 Jul 2021to 22 Feb 2023
Phase: Phase 2
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients from both genders with confirmed keratoconus with evidence of clinical and topographic progression.
Patients with the diagnosis of other ectatic disorders such as post refractive surgery ectasia with evidence of clinical and topographic progression.

Who cannot join

Patients who are pregnant
Patients who are breast-feeding
Patients who have allergy to MMC
Patients with other corneal conditions such as limbal stem cell deficiency (LSCD)
Patients with peripheral marginal keratitis
Patients with history of corneal melting
Patients with history of HSV/VZV keratitis
Patients with history of hydrops

Trial locations and contacts

1 site in 1 country.

Canada1 site

Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4

Other trials in Canada

About this study

Corneal crosslinking (Crosslinking, CXL) is a treatment offered for the stabilization of early corneal ectatic disorders such as keratoconus. Although CXL is an excellent treatment option to stabilize early ectatic corneas, complications include corneal haze, sterile infiltrate, endothelial cell toxicity, treatment failure and stromal scarring. Corneal haze is a common finding in almost all CXL patients and may decrease visual quality. The effect of 0.02% mitomycin C (MMC) for 2 minutes on corneal haze and scarring in refractive surgery is well established in the literature with many clinical studies confirming its effectiveness. Although the pattern of corneal haze after CXL appears to be different from the haze pattern seen following refractive procedures, both processes are thought to be caused by an inflammatory response.

The investigators postulate that MMC can reduce post-CXL haze and scars when using the optimal concentration and duration of exposure.

Conditions: Keratoconus
Being tested: Application of 0.02% MMC over 60 seconds post corneal crosslinking., Corneal crosslinking without the application of 0.02% MMC
Medical subject headings: Keratoconus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Application of 0.02% MMC over 60 seconds post corneal crosslinking.Drug
Topical application of 0.02% MMC on the surface of the cornea post CXL. The surface of the eye is washed thoroughly with Balanced Salt Solution (BSS) over 1 minute after MMC application.
Corneal crosslinking without the application of 0.02% MMCDrug
Topical application of placebo on the surface of the cornea post CXL. The surface of the eye is washed thoroughly with Balanced Salt Solution (BSS) over 1 minute after placebo application.

Study groups in NCT04811924
Study group	Role	What they receive
CXL with MMC	Active comparator	Patients who have undergone corneal cross-linking (CXL) with the application of Mitomycin C (MMC). Receives: Drug: Application of 0.02% MMC over 60 seconds post corneal crosslinking.
CXL without MMC	Placebo comparator	Patients who have undergone corneal cross-linking (CXL) without the application of Mitomycin C (MMC). Receives: Drug: Corneal crosslinking without the application of 0.02% MMC

What is being measured

The primary outcome is the main question the study is designed to answer.

Corneal haze/scarring
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.
Measured: 1 month post-operation
Corneal haze/scarring
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.
Measured: 3 months post-operation
Corneal haze/scarring
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.
Measured: 6 months post-operation
Corneal haze/scarring
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.
Measured: 12 months post-operation
Corneal haze/scarring
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.
Measured: 18 months post-operation

Secondary outcomes (3)

Clinical haze grade
Using slit lamp exam as established in the literature on a scale (the slit lamp clinical haze/scar density grade) ranging from 0 (minimum value) to 4 (maximum value); which means the higher the score, the worse the stromal haze/density is.
Measured: 1 month, 3 months, 6 months, 12 months and 18 months post-operation.
Glare
This will be measured in the treated eye and reported as the logarithm of the straylight parameter.
Measured: 1 month, 3 months, 6 months, 12 months and 18 months post-operation.
Higher-order aberrations
Higher-order aberrations (OPDScan wavefront analyzer, Gamagori, Japan) will be expressed as Zernike polynomials through the sixth order over a 6 mm diameter optical zone. HOA will allow further assessment of the optical quality of the eye.
Measured: 1 month, 3 months, 6 months, 12 months and 18 months post-operation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jul 202122 Feb 2023

First posted23 Mar 2021
Study start26 Jul 2021
Primary completion22 Feb 2023
Study completion22 Feb 2023

Why it stopped: Change in methodolody.

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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized double blinded prospective clinical trial
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04811924
Sponsor's protocol ID: CXLMMC2020
Status last verified: Feb 2023
First submitted: 22 Feb 2021
Last updated: 28 Feb 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Keratoconus trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Mitomycin C on Corneal Haze and Scarring After Corneal Crosslinking in Keratoconus Patients
ClinicalTrials.gov ID: NCT04811924
Acronym / sponsor ID: CXLMMC2020
Conditions: Keratoconus
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Change in methodolody.
Enrolment: 4 participants (actual)
Lead sponsor: Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
Study start: 26 Jul 2021 (actual)
Primary completion: 22 Feb 2023 (actual)
Study completion: 22 Feb 2023 (actual)
First posted: 23 Mar 2021 (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.

The investigators postulate that MMC can reduce post-CXL haze and scars when using the optimal concentration and duration of exposure.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2
Model description: Randomized double blinded prospective clinical trial

Arm	Type	Receives
CXL with MMC	Active comparator	Drug: Application of 0.02% MMC over 60 seconds post corneal crosslinking.Patients who have undergone corneal cross-linking (CXL) with the application of Mitomycin C (MMC).
CXL without MMC	Placebo comparator	Drug: Corneal crosslinking without the application of 0.02% MMCPatients who have undergone corneal cross-linking (CXL) without the application of Mitomycin C (MMC).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients from both genders with confirmed keratoconus with evidence of clinical and topographic progression.
Patients with the diagnosis of other ectatic disorders such as post refractive surgery ectasia with evidence of clinical and topographic progression.

Key exclusion criteria (8 listed)

Patients who are pregnant
Patients who are breast-feeding
Patients who have allergy to MMC
Patients with other corneal conditions such as limbal stem cell deficiency (LSCD)
Patients with peripheral marginal keratitis

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
Application of 0.02% MMC over 60 seconds post corneal crosslinking.Topical application of 0.02% MMC on the surface of the cornea post CXL. The surface of the eye is washed thoroughly with Balanced Salt Solution (BSS) over 1 minute after MMC application.	Drug	CXL with MMC
Corneal crosslinking without the application of 0.02% MMCTopical application of placebo on the surface of the cornea post CXL. The surface of the eye is washed thoroughly with Balanced Salt Solution (BSS) over 1 minute after placebo application.	Drug	CXL without MMC

Primary outcome

Corneal haze/scarring
Time frame: 1 month post-operation
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.
Corneal haze/scarring
Time frame: 3 months post-operation
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.
Corneal haze/scarring
Time frame: 6 months post-operation
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.
Corneal haze/scarring
Time frame: 12 months post-operation
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.
Corneal haze/scarring
Time frame: 18 months post-operation
Corneal haze or scarring will be measured by densitometry. Densitometry values obtained from Scheimpflug images (software 70722, Pentacam HR, Oculus, Germany) will inform backward light scattered reflected by the cornea and therefore reflect the amount of stromal haze, and expressed as grayscale units (GSU), defining the backscattered light in a 0 to 100 scale in concentric zones. A 6mm central zone will be used for the analysis and compartmentalized in: anterior 160 microns depth (epithelium, bowman and anterior stroma), posterior 60 microns depth (endothelium, Descemet and posterior stroma) and the layer in between.

3 secondary outcomes

Clinical haze grade
Time frame: 1 month, 3 months, 6 months, 12 months and 18 months post-operation.
Glare
Time frame: 1 month, 3 months, 6 months, 12 months and 18 months post-operation.
Higher-order aberrations
Time frame: 1 month, 3 months, 6 months, 12 months and 18 months post-operation.

Results and safety

The study was stopped early (reason given: Change in methodolody.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.

Related trials for Keratoconus

RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
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RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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Enrolling by invitationObservational study
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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?

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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Feb 2023. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Change in methodolody.). 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?

Corneal haze/scarring (time frame: 1 month post-operation). The study lists 5 primary outcomes in all. 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 NCT04811924.

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 Feb 2023.