KeratoconusMYKENCT03990740
Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus
An observational study of Keratoconus, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Keratoconus is characterized by a thinning of the cornea, which causes a decrease in visual acuity due to astigmatism. Publications suggest that keratoconus is linked to chronic inflammation (increase in pro-inflammatory cytokines and metalloproteinases (MMP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal sampling
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 12 May 2020
- Phase
- Observational
- 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
Study population: Keratoconus patients requiring first optical corneal transplantation and controls with indication of orbital exenteration due to an orbital tumor.
Who may be able to join
- For the cases :
- Suffering from keratoconus and requiring a first optical corneal transplant
- For the controls:
- Orbital exenteration operation due to an orbital tumor
- Absence of any anomaly of the ocular surface observed during the slit lamp examination at the last preoperative consultation
Who cannot join
- For the cases:
- Keratoconus patient requiring a tectonic corneal transplant
- Known pregnancy, or breastfeeding
- For the controls:
- History of orbital radiotherapy
- History of corneal surgery
Show all 11Show fewer
- History of corneal surface tumour
- Eye surface abnormality noted in the preoperative period
- Known keratoconus
- Known pregnancy, or breastfeeding
- Secondary exclusion if a keratoconus is diagnosed during the immunohistochemical analysis by visualization of Bowman membrane interruption
About this study
Official title: Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus (MYKE)
Keratoconus is characterized by a thinning of the cornea, which causes a decrease in visual acuity due to astigmatism.
Publications suggest that keratoconus is linked to chronic inflammation (increase in pro-inflammatory cytokines and metalloproteinases (MMP). Direct epithelial-stromal interactions (D-ESI) have a role in the induction of metalloproteinases (MMP) and the differentiation of fibroblasts into myofibroblasts via an EMMPRIN membrane glycoprotein (extracellular matrix membran MMP inducer - CD 147). On a healthy cornea, EMMPRIN's effects are prevented by a lack of contact between epithelial and stromal cells through a basement membrane, which is altered in the keratoconus The hypothesis is that stromal thinning of the keratoconus could be related to increased expression of EMMPRIN by epithelial and stromal cells (resulting in increased MMP synthesis), with a preponderance at the most deformed areas.
The main objective is to demonstrate a transformation of fibroblasts to myofibroblasts in the corneal stroma of keratoconus patients.
- Conditions
- Keratoconus
- Being tested
- Corneal sampling
- Keywords
- Metalloproteinase, Glycoprotein, Cornea, Direct epithelial-stromal interactions, Fibroblasts, Myofibroblasts
- Medical subject headings
- Keratoconus, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal samplingProcedure or surgery
Corneal samples will be taken during corneal transplants for cases and orbital exenterations for controls. The mRNA (messenger ribonucleic acid) will be extracted and a retrotranscription will be made to obtain cDNA (complementary DNA). A qPCR (quantitative polymerase chain reaction) will be able to quantify the expression of alpha-SMA, MMP 1-2-3 and 9, and EMMPRIN.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients suffering from keratoconus and requiring a first optical corneal transplant Receives: Procedure: Corneal sampling | |
| Controls | Patients with an indication of orbital exenteration operation due to an orbital tumor Receives: Procedure: Corneal sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of alpha-SMA's (Smooth Muscle Actin) messenger RNA expression evaluated by quantitative PCR (RT-qPCR) in corneal stroma in keratoconus patients compared to non-keratoconus controls
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Nov 2019
- Primary completion12 May 2020
- Study completion12 May 2020
Why it stopped: Logistical difficulties : protocol never finalized nor submitted
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 Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990740
- Sponsor's protocol ID
- EGN_2017_22
- Acronym
- MYKE
- Status last verified
- May 2020
- First submitted
- 11 Jun 2019
- Last updated
- 14 May 2020
- Results posted
- 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 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus (MYKE)
- ClinicalTrials.gov ID
- NCT03990740
- Acronym / sponsor ID
- MYKE / EGN_2017_22
- Conditions
- Keratoconus
- Keywords
- Metalloproteinase, Glycoprotein, Cornea, Direct epithelial-stromal interactions, Fibroblasts, Myofibroblasts
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Logistical difficulties : protocol never finalized nor submitted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 19 Jun 2019 (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 characterized by a thinning of the cornea, which causes a decrease in visual acuity due to astigmatism.
Publications suggest that keratoconus is linked to chronic inflammation (increase in pro-inflammatory cytokines and metalloproteinases (MMP). Direct epithelial-stromal interactions (D-ESI) have a role in the induction of metalloproteinases (MMP) and the differentiation of fibroblasts into myofibroblasts via an EMMPRIN membrane glycoprotein (extracellular matrix membran MMP inducer - CD 147). On a healthy cornea, EMMPRIN's effects are prevented by a lack of contact between epithelial and stromal cells through a basement membrane, which is altered in the keratoconus The hypothesis is that stromal thinning of the keratoconus could be related to increased expression of EMMPRIN by epithelial and stromal cells (resulting in increased MMP synthesis), with a preponderance at the most deformed areas.
The main objective is to demonstrate a transformation of fibroblasts to myofibroblasts in the corneal stroma of keratoconus patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Procedure: Corneal samplingPatients suffering from keratoconus and requiring a first optical corneal transplant |
| Controls | – | Procedure: Corneal samplingPatients with an indication of orbital exenteration operation due to an orbital tumor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Keratoconus patients requiring first optical corneal transplantation and controls with indication of orbital exenteration due to an orbital tumor.
Key inclusion criteria (5 listed)
- For the cases :
- For the controls:
Key exclusion criteria (11 listed)
- For the cases:
- For the controls:
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 |
|---|---|---|
| Corneal samplingCorneal samples will be taken during corneal transplants for cases and orbital exenterations for controls. The mRNA (messenger ribonucleic acid) will be extracted and a retrotranscription will be made to obtain cDNA (complementary DNA). A qPCR (quantitative polymerase chain reaction) will be able to quantify the expression of alpha-SMA, MMP 1-2-3 and 9, and EMMPRIN. | Procedure or surgery | Cases, Controls |
Primary outcome
Comparison of alpha-SMA's (Smooth Muscle Actin) messenger RNA expression evaluated by quantitative PCR (RT-qPCR) in corneal stroma in keratoconus patients compared to non-keratoconus controls
Time frame: 12 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 11 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: withdrawn, as of the sponsor's last update on 14 May 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Comparison of alpha-SMA's (Smooth Muscle Actin) messenger RNA expression evaluated by quantitative PCR (RT-qPCR) in corneal stroma in keratoconus patients compared to non-keratoconus controls (time frame: 12 hours). 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 14 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.