Influence of Supine Positioning on the Outcomes After Descemet Membrane Endothelial Keratoplasty (DMEK)
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
- 否
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
干预措施: Duration of Supine Positioning (Procedure)
5 day supine positioning
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
Maximilian Friedrich
Principal Investigator
University Hospital Heidelberg
