Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- estimate variance and effect size order to inform power calculations for further studies.
研究概览
简要总结
The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.
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
- •Patients having surgery for idiopathic full thickness macular hole
- •Able and willing to posture face-down for 10 days postoperatively
- •Agree to participate in the trial and able to give informed consent
排除标准
- •History of visual loss suggesting a duration of macular hole greater than 12 months
- •Patients unable or unwilling to posture face-down for 10 days postoperatively
- •History of trauma that may have been causative
- •Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).
- •Previous vitrectomy surgery
- •Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.
研究组 & 干预措施
No posture
Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to avoid supine posturing for seven days after surgery, but will not be advised to posture in the face down or prone position.
Face down posture
Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to posture in the face down or prone position for 50 minutes per hour for seven days.
干预措施: Face down posture (Behavioral)
结局指标
主要结局
estimate variance and effect size order to inform power calculations for further studies.
时间窗: one year
次要结局
- visual acuity and complications(one year)
- estimate recruitment rate and establish protocol/procedure(one year)
研究者
David Yorston
Consultant Ophthalmologist
NHS Greater Glasgow and Clyde