跳至主要内容
临床试验/NCT04360603
NCT04360603Unknown不适用

The Safety Outcomes of 27 Gauge Vitrectomy for Posterior Segment Disease in High Myopia

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2020年4月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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