跳至主要内容
临床试验/NCT03990740
NCT03990740撤回不适用

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

Fondation Ophtalmologique Adolphe de Rothschild0 个研究点开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
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 controls

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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 controls

时间窗: 12 hours

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

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