KERatoconus and Metalloproteinases InvesTigation (KERMIT)

December 9, 2020 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Opthalmologique A de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with keratoconus and controls subjects without keratoconus

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Eric GABISON, MD, PhD, Fondation OPH A de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2016

Primary Completion (Actual)

June 26, 2020

Study Completion (Actual)

November 26, 2020

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

December 10, 2020

Last Update Submitted That Met QC Criteria

December 9, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGN_2016_6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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