The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEK
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Corneal Endothelial Cell Density
研究概览
简要总结
This study aims to investigate the influence of postoperative head position on clinical outcomes after DMEK via a wearable sensor.
详细描述
After Descemet Membrane Endothelial Keratoplasty (DMEK) patients are recommended to keep a strict supine position within the first few days after surgery in order to attach the graft to the corneal stroma. It has not yet been investigated to what extent the head position actually has an effect on the outcome.
In this study, the participants head position will be continuously monitored within the first three days after DMEK. Participants wear a headband in which a small sensor is inserted. The degree of deviation from the neutral position will then be correlated with clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •all patients undergoing DMEK
排除标准
- •no specific exclusion criteria
结局指标
主要结局
Corneal Endothelial Cell Density
时间窗: three months after surgery
measured in cells/mm2
次要结局
- Best Corrected Visual Acuity(prior to surgery, three and six months after surgery)
- Number of Re-Bubblings(six months after surgery)
- Corneal Endothelial Density(six months after surgery)
- Central Corneal Thickness(prior to surgery, three and six months after surgery)
研究者
Peter Wiedemann
Director
University of Leipzig