The Eye Hospital of Tianjin Medical University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the closure rate of Macular hole
研究概览
简要总结
The purpose of this study is to observe the technologic application of no-touch fluid-air exchange in Surgery of Idiopathic Macula Hole.
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 (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients were diagnosed as having an idiopathic macular hole(IMH) by Optical Coherence Tomography(OCT).
排除标准
- •Myopia of >6 diopters
- •Ocular trauma and other systematic or ocular issues associated with IMHs，such as the other macula disease, for example the degeneration of macula.
研究组 & 干预措施
no-touch fluid-air exchange group
All patients in no-touch fluid-air exchange group will have a surgery of vitrectomy metrectomy and internal membrane peeling and gas tamponed.In this surgery ,investigator will not touch the macular area,especially the area of the macular hole and investigator will not have the fluid-air exchange of the macular area.
干预措施: no-touch fluid-air exchange (Procedure)
no-touch fluid-air exchange group
All patients in no-touch fluid-air exchange group will have a surgery of vitrectomy metrectomy and internal membrane peeling and gas tamponed.In this surgery ,investigator will not touch the macular area,especially the area of the macular hole and investigator will not have the fluid-air exchange of the macular area.
干预措施: vitrectomy metrectomy and internal membrane peeling and gas tamponed (Procedure)
the tradional group
All patients in no-touch fluid-air exchange group will have a surgery of vitrectomy metrectomy and internal membrane peeling and gas tamponed.In this surgery ,investigator will touch the macular area and investigator will have the fluid-air exchange.
干预措施: vitrectomy metrectomy and internal membrane peeling and gas tamponed (Procedure)
结局指标
主要结局
the closure rate of Macular hole
时间窗: six month
the closure rate of Macular hole
次要结局
未报告次要终点
研究者
Bojie Hu
Head of Ophthalmology department, Principal Investigator, Associate Senior Physician
Tianjin Medical University Eye Hospital