NCT02891655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 2, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2020

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

3.6 years

First QC Date

August 25, 2016

Last Update Submit

December 9, 2020

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells

    baseline

Study Arms (2)

surgery for keratoconus

Other: immuno-histo-chemical analysis

refractive surgery (control patients)

Other: immuno-histo-chemical analysis

Interventions

immuno-histo-chemical analysisOTHER

in vitro immuno-histo-chemical analysis of corneal epithelium

refractive surgery (control patients)surgery for keratoconus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with keratoconus and controls subjects without keratoconus

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Opthalmologique A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Eric GABISON, MD, PhD

    Fondation OPH A de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 7, 2016

Study Start

December 2, 2016

Primary Completion

June 26, 2020

Study Completion

November 26, 2020

Last Updated

December 10, 2020

Record last verified: 2020-12

Locations

FR(1)