Effect of Descemet Membrane Polishing in Fuchs Endothelial Corneal Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Compare the progression of the number of guttata with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy
研究概览
简要总结
Fuchs endothelial corneal dystrophy (FECD) is the leading indication for corneal transplantation worldwide. It is characterized by the accumulation of guttae and progressive loss of corneal endothelial cells, leading to corneal edema and visual impairment. Endothelial keratoplasty remains the standard treatment; however, graft shortages have driven the development of cell-based therapies involving the injection of cultured endothelial cells. A key unresolved issue is whether removal of the pathological endothelium prior to injection improves cell adhesion. Clinical data are limited and sometimes contradictory, particularly regarding endothelial polishing. The actual effectiveness of this procedure in removing guttae and enhancing the survival of injected cells remains uncertain. Therefore, an in vivo clinical evaluation is required to assess its impact on guttae removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient affiliated with or entitled to a social security scheme
- •Patient scheduled for endothelial keratoplasty for Fuchs endothelial corneal dystrophy
- •Patient having received full information and having provided written informed consent
排除标准
- •Pregnant women
- •Adults under legal protection (guardianship/curatorship) or unable to provide informed consent
研究组 & 干预措施
Experimental Group
干预措施: Fuchs Polishing (Procedure)
结局指标
主要结局
Compare the progression of the number of guttata with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy
时间窗: After surgery : Months 1
Comparison of the number of guttae per unit area (guttae/mm²) between the polished half of the sample and the untreated half. Measurement performed by image analysis after capturing the entire surface of the pathological endothelium removed by Descemetorhexis in FECD patients.
次要结局
- Compare the progression of guttae height with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD).(After surgery : Months 1)
- Compare the removal of corneal endothelial cells with and without central endothelial polishing in Fuchs' endothelial corneal dystrophy (FECD)(After surgery : Months 1)