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Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus

Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus (MYKE)

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03990740
Acronym
MYKE
Enrollment
0
Registered
2019-06-19
Start date
2019-11-01
Completion date
2020-05-12
Last updated
2020-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Metalloproteinase, Glycoprotein, Cornea, Direct epithelial-stromal interactions, Fibroblasts, Myofibroblasts

Brief summary

Keratoconus is characterized by a thinning of the cornea, which causes a decrease in visual acuity due to astigmatism. Publications suggest that keratoconus is linked to chronic inflammation (increase in pro-inflammatory cytokines and metalloproteinases (MMP). Direct epithelial-stromal interactions (D-ESI) have a role in the induction of metalloproteinases (MMP) and the differentiation of fibroblasts into myofibroblasts via an EMMPRIN membrane glycoprotein (extracellular matrix membran MMP inducer - CD 147). On a healthy cornea, EMMPRIN's effects are prevented by a lack of contact between epithelial and stromal cells through a basement membrane, which is altered in the keratoconus The hypothesis is that stromal thinning of the keratoconus could be related to increased expression of EMMPRIN by epithelial and stromal cells (resulting in increased MMP synthesis), with a preponderance at the most deformed areas. The main objective is to demonstrate a transformation of fibroblasts to myofibroblasts in the corneal stroma of keratoconus patients.

Interventions

Corneal samples will be taken during corneal transplants for cases and orbital exenterations for controls. The mRNA (messenger ribonucleic acid) will be extracted and a retrotranscription will be made to obtain cDNA (complementary DNA). A qPCR (quantitative polymerase chain reaction) will be able to quantify the expression of alpha-SMA, MMP 1-2-3 and 9, and EMMPRIN.

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* For the cases : \- Suffering from keratoconus and requiring a first optical corneal transplant * For the controls: * Orbital exenteration operation due to an orbital tumor * Absence of any anomaly of the ocular surface observed during the slit lamp examination at the last preoperative consultation

Exclusion criteria

* For the cases: * Keratoconus patient requiring a tectonic corneal transplant * Known pregnancy, or breastfeeding * For the controls: * History of orbital radiotherapy * History of corneal surgery * History of corneal surface tumour * Eye surface abnormality noted in the preoperative period * Known keratoconus * Known pregnancy, or breastfeeding * Secondary exclusion if a keratoconus is diagnosed during the immunohistochemical analysis by visualization of Bowman membrane interruption

Design outcomes

Primary

MeasureTime frame
Comparison of alpha-SMA's (Smooth Muscle Actin) messenger RNA expression evaluated by quantitative PCR (RT-qPCR) in corneal stroma in keratoconus patients compared to non-keratoconus controls12 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026