The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Incidence of intraoperative sclerotomy site wound leakage
研究概览
简要总结
In recent decade, a major improvement in vitreoretinal surgery was the use of small gauge surgical systems that improved the safety of vitrectomy and also reduced the surgical time. However, there were still some concerns regarding small gauge vitrectomy system, especially 27-gauge system, in the stability of its instruments and the efficacy of removing vitreous during surgery. Although there were some studies that had reported the surgical outcomes of 27G vitrectomy system, none had focused on patients with high myopia. The highly myopic patients usually had thinner sclera, which was a risk factor for wound leakage after sutureless vitrectomy, they also had longer axial length which would make the surgical procedure more difficult especially in macular surgery.
Based on previous clinical finding, gas leakage was 36.4% in 25G , while 27G sclerotomy showing less leakage comparing to larger gauge sclerotomy, the investigators believe 27G may have its clinical advantages in overcoming the thinner sclera of high myopia, and show the superiority of leakage control.
Hypothesis:
The 27G vitrectomy system has lower sclerotomy wound leakage rate compared with 25G system
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
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of intraoperative sclerotomy site wound leakage
时间窗: immediately at the end of surgery
The incidence of intraoperative sclerotomy site wound leakage
次要结局
- Incidence of hypotony(post-operation day 1, 3, week 1, month 1, 3, 6)
- Incidence of endophthalmitis(post-operation day 1, 3, week 1, month 1, 3, 6)
- Incidence of subconjunctival hemorrhage(post-operation day 1, 3, week 1, month 1, 3, 6)
- Incidence of postoperative sclerotomy site wound leakage(post-operation day 1, 3, week 1, month 1, 3, 6)
- Incidence of instrument bending(during operation)
