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KERatoconus and Metalloproteinases InvesTigation (KERMIT)

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ClinicalTrials.gov Identifier: NCT02891655
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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. 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.

Condition or disease Intervention/treatment
Keratoconus Other: immuno-histo-chemical analysis

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Actual Study Start Date : December 2, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
surgery for keratoconus Other: immuno-histo-chemical analysis
in vitro immuno-histo-chemical analysis of corneal epithelium

refractive surgery (control patients) Other: immuno-histo-chemical analysis
in vitro immuno-histo-chemical analysis of corneal epithelium




Primary Outcome Measures :
  1. expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells [ Time Frame: baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with keratoconus and controls subjects without keratoconus
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891655


Contacts
Contact: Laurence SALOMON, MD, PhD 0033148036431 lsalomon@for.paris

Locations
France
Fondation Opthalmologique A de Rothschild Recruiting
Paris, France, 75019
Contact: Eric GABISON       egabison@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
Principal Investigator: Eric GABISON, MD, PhD Fondation OPH A de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02891655     History of Changes
Other Study ID Numbers: EGN_2016_6
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases