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临床试验/NCT07373821
NCT07373821招募中不适用

Influence of Supine Positioning on the Outcomes After Descemet Membrane Endothelial Keratoplasty (DMEK)

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年10月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
1
主要终点
Area of Graft Detachment in mm²

研究概览

简要总结

The goal of this clinical trial is to learn if a longer period of lying on the back after corneal transplant surgery (Descemet Membrane Endothelial Keratoplasty, DMEK) helps the transplant stick better in the eye. It will also learn about side effects, such as back pain.

The main questions it aims to answer are:

  • Does lying on the back for 5 days reduce the size of transplant detachment compared to lying on the back for only 1 day?
  • Do participants who lie on their back longer need fewer additional procedures (rebubbling)?
  • What symptoms or problems do participants experience with short vs. long back positioning?

Researchers will compare two groups:

  • 1 day of back positioning
  • 5 days of back positioning

Participants will:

  • Be randomly assigned to one of the two positioning groups
  • Wear a movement sensor that records head position
  • Have their eyes checked regularly with vision tests and imaging (AS-OCT)
  • Answer questions about their vision and comfort
  • Keep a diary of any positioning-related complaints, such as back pain

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 (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Fuchs Endothelial Corneal Dystrophy Bullous Keratopathy

排除标准

  • Comorbidities preventing supine positioning

研究组 & 干预措施

1 day supine positioning

Experimental

干预措施: Duration of Supine Positioning (Procedure)

5 day supine positioning

Active Comparator

干预措施: Duration of Supine Positioning (Procedure)

结局指标

主要结局

Area of Graft Detachment in mm²

时间窗: First two postoperative weeks

The area of graft detachment will be measured in mm² using anterior segment optical coherence tomography and a custom-built segmentation tool

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maximilian Friedrich

Principal Investigator

University Hospital Heidelberg

研究点 (1)

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