KERatoconus and Metalloproteinases InvesTigation

Keratoconus Clinical Trial

— KERMIT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02891655
• Other study ID #: EGN_2016_6
• Status: Completed
• Start date: December 2, 2016
• Est. completion date: November 26, 2020

Study information

• Verified date: December 2020
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 26, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Other:
• immuno-histo-chemical analysis
in vitro immuno-histo-chemical analysis of corneal epithelium

Locations

Country	Name	City	State
France	Fondation Opthalmologique A de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	expression of the Extracellular Matrix Metalloproteinase Inducer (EMMPRIN) in epithelial cells		baseline