Metalloproteinases and Recurrent Corneal Erosion Syndrome | NCT02891694

Studies
Metalloproteinases and Recurrent Corneal Erosion Syndrome

NCT02891694

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Dec 10, 2020Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Recurrent Corneal Erosion Syndrome

Interventions

in vitro immuno-histo-chemical analysis of corneal epithelium

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2016Actual

Primary Completion Date

Jun 26, 2020Actual

Completion Date

Nov 26, 2020Actual

First Submitted Date

Aug 25, 2016

First Submission Date that Met QC Criteria

Sep 6, 2016

First Posted Date

Sep 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2020

Last Update Posted Date

Dec 10, 2020Actual

Description Module

Brief Summary

Recurrent corneal erosion (RCE) syndrome can be observed either in the context of a dystrophy of the basement membrane or following corneal trauma. This syndrome is characterized by recurrent episodes of ocular pain more or less associated with localized separations between the outer epithelium and the epithelial basal lamina (basement membrane) because of anchorage abnormalities between these two corneal layers. This could be the result of an increased expression of metalloproteinases cleaving the hemidesmosomes which anchor epithelium to the basement membrane.

The investigators hypothesis is that episodes of RCEs are favored by a hyper- expression of matricial metalloprotease 9 (MMP-9) induced by EMMPRIN and Galectin-3. The identification of such induction could lead to development of therapeutics inhibiting EMMPRIN and Galectin- 3 in the RCE syndrome.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
recurrent corneal erosion			Other: in vitro immuno-histo-chemical analysis of corneal epithelium
control patients (refractive surgery)			Other: in vitro immuno-histo-chemical analysis of corneal epithelium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
in vitro immuno-histo-chemical analysis of corneal epithelium	Other		control patients (refractive surgery) recurrent corneal erosion

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years old
Recurrent Corneal Erosion Syndrome, with - failure of medical treatment and therapeutic photokeratectomy scheduled
Photorefractive surgical keratectomy (control patients)

Exclusion Criteria:

Opposition to participation in the study
Known pregnancy or breast-feeding patient
No medical insurance coverage

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Recurrent Corneal Erosion Syndrome and control patients (undergoing photorefractive surgical keratectomy)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric GABISON, MD, PhD	Fondation OPH A de Rothschild	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Opthalmologique A de Rothschild		Paris		75019	France