A Randomized Clinical Trial of Face-down Protocol Versus Non-face-down Protocol After Surgery for Macular Holes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Macular hole closure rate
研究概览
简要总结
Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial.
Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic macular hole stage II-IV
- •Informed consent
- •Duration of symptoms ≤ 24 months
排除标准
- •Previous vitreomacular surgery
- •Myopia ≥ 8 diopters
- •Ocular trauma
- •Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)
研究组 & 干预措施
Face-down positioning
Patients advised face-down positioning after surgery for macular hole.
干预措施: Vitrectomy & Intraocular gas fill (Procedure)
Face-down positioning
Patients advised face-down positioning after surgery for macular hole.
干预措施: Postoperative face-down positioning (Procedure)
Non-face-down positioning
Patients advised non-face-down positioning after surgery for macular hole.
干预措施: Vitrectomy & Intraocular gas fill (Procedure)
结局指标
主要结局
Macular hole closure rate
时间窗: 3 months
Macular hole closure rate assessed by optical coherence tomography
次要结局
- ETDRS Visual Acuity Gain(3 months)
- Degree of postoperative head incline(3 days)
- Degree of ocular gas fill(4 days)
研究者
Mark Alberti
M.D.
Glostrup University Hospital, Copenhagen