Objective Evaluation of Postoperative Positioning in Macular Hole Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 205
- 试验地点
- 8
- 主要终点
- Macular hole closure
研究概览
简要总结
The macular hole formation takes place in the centre of the retina. A closure of the macular hole is believed to take place if the central retinal area is kept dry in the postoperative period. Therefore the eye is filled with a gas mix and the patients are urged to avoid the supine position in the first postoperative days. The investigators have developed a positioning measuring device which can measure the extent of supine positioning time. Patients are to carry the positioning measuring device during the first postoperative 24 hours. Hereby the investigators search new knowledge concerning patients compliance and its relation to macular hole closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Primary macular hole
- •Duration less than 24 months
- •Informed consent
排除标准
- •Secondary macular hole i.e. trauma, excessive myopia (more than 6 dioptres)
- •Previous vitreomacular surgery
- •Age under 18 years
- •Unable to sign
研究组 & 干预措施
Positioning measuring device
The supine time during the first postoperative day is measured
干预措施: Positioning measuring device (Other)
结局指标
主要结局
Macular hole closure
时间窗: 2 weeks
次要结局
- Time in supine sleeping position(1 day after enrollment)