Air Tamponade and Non-supine Positioning in Macular Hole Surgery. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Macular hole closure verified on OCT
研究概览
简要总结
This is a prospective, multicenter, randomized non-inferiority trial, where the macular hole closure rate with intraocular air tamponade is compared to the closure rate with gas tamponade.The patients are randomized to receive either air or gas (26% SF6) as intraocular tamponade, just prior to the intraocular flushing of the tamponade during the vitrectomy procedure. Postoperatively, the patients adhere to the nonsupine regimen for three days, and the tennis ball technique is used during sleep to enhance patients' positioning compliance.
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
- 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 ≤ 400 μm
- •Duration no more than 24 months
- •Able to sign informed content
- •Signed informed content
排除标准
- •Earlier vitreoretinal surgery in present eye
- •Secondary macular holes caused by other conditions than vitreomacular traction
- •Myopic macular hole, i.e. excessive myopia (more than -6 dioptres)
- •Posttraumatic macular hole
- •Macular holes secondary to retinal detachment or other retinal diseases
- •Surgery under general anesthesia
- •Visual acuity below 20/40 in fellow-eye
研究组 & 干预措施
Gas tamponade
Gas as intraocular tamponade.
干预措施: Gas tamponade (Procedure)
Air tamponade
Air as intraocular tamponade.
干预措施: Air tamponade (Procedure)
结局指标
主要结局
Macular hole closure verified on OCT
时间窗: 2 - 8 weeks postoperatively
Macular hole closure verified on OCT after one macular hole intervention
次要结局
- Closure of macular holes >250 µm and ≤ 400 µm(2 - 8 weeks postoperatively)
- Closure of macular holes ≤ 250 µm(2 - 8 weeks postoperatively)
- Intraocular pressure(First postoperative day)
- Visual acuity(2 - 8 weeks postoperatively)