NCT01226160已完成1 期
Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.
研究概览
简要总结
This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.
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
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •full thickness macular hole
- •>16 years old
排除标准
- •any history of previous intraocular surgery (including cataract surgery)
- •history of ocular trauma
- •history of visual loss greater than 1 year
研究组 & 干预措施
Face-down posturing group
Experimental
Postoperative face-down positioning for 10 days after surgery.
干预措施: Postoperative face-down posturing (Procedure)
Non-posturing group
Active Comparator
avoid a face-up position for 10 days after surgery
干预措施: Postoperative non-posturing group (Procedure)
结局指标
主要结局
Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.
时间窗: 6 weeks
次要结局
- Visual acuity assessed 6 weeks following surgery by Snellen charts.(6 weeks)
研究者
研究点 (1)
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