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临床试验/NCT02793310
NCT02793310已完成不适用

Corneal Transplantation by DMEK - is it Really Better Than DSAEK?

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2016年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Change in best-corrected visual acuity

研究概览

简要总结

The purpose of this study is to determine whether corneal transplantation by Descemet Membrane Endothelial Keratoplasty more favourable and cost-effective is compared to Descemet Stripping Automated Endothelial Keratoplasty for Fuchs Endothelium Corneal Dystrophy.

详细描述

FECD is a progressive, multifactorial and irreversible disease characterized by accelerated loss of corneal endothelial cells in the innermost layer of the cornea that leads to vision impairment and potential blindness if left untreated. FECD is responsible for more than 50% of the 1.300 annual corneal transplantations in the Netherlands.

Corneal transplantation improves vision and quality of life in patients with corneal disease. Currently, the standard of care for patients with Fuchs Endothelial Corneal Dystrophy (FECD) is Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), in which only the posterior layers of the cornea are transplanted. However, visual recovery following DSAEK is suboptimal. Descemet Membrane Endothelial Keratoplasty (DMEK), the latest technique in corneal transplantation involves transplantation of only a monolayer of corneal endothelium and Descemet's membrane providing the thinnest endothelial graft possible. DMEK has been suggested to result in faster and better visual recovery compared to DSAEK. While the economic burden, both medical and social, from this disease has not been assessed to date, costs associated with corneal transplantation reach $ 110 million dollars yearly for the 47.000 transplantations in the USA.

The objective of this project is to assess the effects and costs of DMEK vs. DSAEK in order to determine whether the new technique is effective and cost-effective over the standard technique.

The primary outcome measure is best-corrected visual acuity. Secondary outcome measures are contrast acuity, astigmatism, quality of vision, endothelial cell loss, incidence of graft rejection, primary graft failure, cornea donor loss due to preparation, and generic and vision-related quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Cornea decompensation caused Fuchs Endothelial Corneal Dystrophy

排除标准

  • Ocular comorbidities other than cataract
  • Previous corneal transplantation
  • Human leukocyte antigen (HLA) matched keratoplasty
  • Inability to complete follow-up

研究组 & 干预措施

DMEK

Active Comparator

The intervention group will receive cornea transplantation by DMEK

干预措施: DMEK (Procedure)

DSAEK

Active Comparator

The usual care / control group will receive cornea transplantation by DSAEK

干预措施: DSAEK (Procedure)

结局指标

主要结局

Change in best-corrected visual acuity

时间窗: Preoperatively and 3, 6, 12 months post-operatively

Visual acuity will be measured by ETDRS letter charts

次要结局

  • Change in corneal scatter(Preoperatively and 3, 6, 12 months post-operatively)
  • Change in endothelial cell loss(Preoperatively and 3, 6, 12 months post-operatively)
  • Incidence of graft rejection(3, 6, 12 months post-operatively)
  • Incidence of primary graft failure(3, 6, 12 months post-operatively)
  • Change in vision-related quality of life(Preoperatively and 3, 6, 12 months post-operatively)
  • Incidence of cornea donor loss due to preparation(Preoperatively)
  • Change in contrast sensitivity(Preoperatively and 3, 6, 12 months post-operatively)
  • Change in astigmatism(Preoperatively and 3, 6, 12 months post-operatively)
  • Change in generic quality of life(Preoperatively and 3, 6, 12 months post-operatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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