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临床试验/NCT04902170
NCT04902170已完成不适用

The Surgical Outcomes of Long-shaft Vitrectomy Probe for Vitreoretinal Diseases in Highly Myopic Eyes

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
operation time

研究概览

简要总结

This study aimed to compare the safety and efficacy of vitrectomy probe with different shaft lengths in vitreoretinal surgery of highly myopic patients. In this randomized controlled study, highly myopic patients who had axial length more than 26 mm and needed vitreoretinal surgery will be enrolled. The enrolled patients will be randomized into "30 mm shaft length group"(trial group) and "27mm shaft length group"(controlled group). We will compare the rate of wound leakage, hypotony, subconjunctival hemorrhage, probe bending, trocar removal, and endophthalmitis between the two groups. We would like to evaluate the efficacy and safety of the 30 mm shaft length vitrectomy probe.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Highly myopic patients (axial length > 26mm) with vitreoretinal diseases or maculopathy requiring pars plana vitrectomy

排除标准

  • Previous history of pars plana vitrectomy
  • Surgical plan combining encircling buckle
  • Silicone oil or perfluorocarbon liquid use intraoperatively
  • Previous history of pterygium surgery, trabeculectomy, glaucoma surgery
  • Previous history of corneal, conjunctival, or scleral laceration
  • History of connective tissue disease

结局指标

主要结局

operation time

时间窗: intra-operative

record the operation time and time of core vitrectomy

trocar removal rate

时间窗: intra-operative

trocar removal would be performed if the length of vitrectomy probe was not adequate

次要结局

  • instrument bending(intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Long-shaft Vitrectomy Probe in Highly Myopic Eyes | 临床试验