KeratoconusKERMITNCT02891655
KERatoconus and Metalloproteinases InvesTigation
An observational study of Keratoconus, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Corneal stromal thinning observed in keratoconic eyes could result from an increased synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by an overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and Galectin-3 by epithelial cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- immuno-histo-chemical analysis
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2016to 26 Nov 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: patients with keratoconus and controls subjects without keratoconus
Who may be able to join
- age > 18 years old
- Patient with keratoconus undergoing corneal collagen cross-linking (epithelium-off methods)
- Patient with keratoconus undergoing his first corneal graft for optical indication (control)
Who cannot join
- Patient with keratoconus undergoing corneal graft for tectonic indication
- Patient undergoing corneal refractive surgery (refractive photokeratectomy) with a normal topography, a normal slit lamp examination and no previous ophthalmic condition (control)
- pregnant or breast feeding patient
- patient under judiciary protection
- patient opposition to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Corneal stromal thinning observed in keratoconic eyes could result from an increased synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by an overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and Galectin-3 by epithelial cells. A differential expression of EMMPRIN, Galectin-3 and metalloproteinases (MMP) may be observed between the apex of the keratoconus and the peripheral cornea. Highlighting the implication of EMMPRIN and Galectin-3 could lead to the development of specific inhibitors to slow or to stop keratoconus evolution.
- Conditions
- Keratoconus
- Being tested
- immuno-histo-chemical analysis
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immuno-histo-chemical analysisOther
in vitro immuno-histo-chemical analysis of corneal epithelium
| Study group | Role | What they receive |
|---|---|---|
| surgery for keratoconus | Not described Receives: Other: immuno-histo-chemical analysis | |
| refractive surgery (control patients) | Not described Receives: Other: immuno-histo-chemical analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start2 Dec 2016
- Primary completion26 Jun 2020
- Study completion26 Nov 2020
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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Eric GABISON, MD, PhD, Principal investigator, Fondation OPH A de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891655
- Sponsor's protocol ID
- EGN_2016_6
- Acronym
- KERMIT
- Status last verified
- Dec 2020
- First submitted
- 25 Aug 2016
- Last updated
- 10 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KERatoconus and Metalloproteinases InvesTigation
- ClinicalTrials.gov ID
- NCT02891655
- Acronym / sponsor ID
- KERMIT / EGN_2016_6
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 2 Dec 2016 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 7 Sep 2016 (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.
Corneal stromal thinning observed in keratoconic eyes could result from an increased synthesis of MMP at the level of the anterior stroma and the corneal epithelium induced by an overexpression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) and Galectin-3 by epithelial cells. A differential expression of EMMPRIN, Galectin-3 and metalloproteinases (MMP) may be observed between the apex of the keratoconus and the peripheral cornea. Highlighting the implication of EMMPRIN and Galectin-3 could lead to the development of specific inhibitors to slow or to stop keratoconus evolution.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery for keratoconus | – | Other: immuno-histo-chemical analysis |
| refractive surgery (control patients) | – | Other: immuno-histo-chemical analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with keratoconus and controls subjects without keratoconus
Key inclusion criteria (3 listed)
- age > 18 years old
- Patient with keratoconus undergoing corneal collagen cross-linking (epithelium-off methods)
- Patient with keratoconus undergoing his first corneal graft for optical indication (control)
Key exclusion criteria (5 listed)
- Patient with keratoconus undergoing corneal graft for tectonic indication
- Patient undergoing corneal refractive surgery (refractive photokeratectomy) with a normal topography, a normal slit lamp examination and no previous ophthalmic condition (control)
- pregnant or breast feeding patient
- patient under judiciary protection
- patient opposition to participate in the study
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 |
|---|---|---|
| immuno-histo-chemical analysisin vitro immuno-histo-chemical analysis of corneal epithelium | Other | refractive surgery (control patients), surgery for keratoconus |
Primary outcome
expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells
Time frame: baseline
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 10 Dec 2020.
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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.
Eric GABISON, MD, PhD principal investigator
Fondation OPH A de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by Fondation Ophtalmologique Adolphe de Rothschild 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 3 inclusion and 5 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 10 Dec 2020. 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?
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?
expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells (time frame: baseline). 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 10 Dec 2020.