跳至主要内容
临床试验/NCT03457584
NCT03457584已完成不适用

Effect of Air-tamponade on Intraretinal Cystoid Changes After Vitrectomy With Membrane Peeling

Vienna Institute for Research in Ocular Surgery1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
resorption of intraretinal cystoid changes after surgery

研究概览

简要总结

Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. Patients are randomized for balanced salt solution (BSS) or air-tamponade.

详细描述

Patients with intraretinal cystoid changes before scheduled membrane peeling for epiretinal membranes are included. 23G-pars plana vitrectomy with membrane peeling is performed in all patients. Before surgery patients are randomized for BSS or air-tamponade. Optical coherence tomography (OCT) is performed 5 days after and 3 months after surgery, visual acuity is measured 3 months after surgery.

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

入选标准

  • •epiretinal membranes and intraretinal cystoid changes

排除标准

  • •macular edema due to other reason than epiretinal membrane
  • •hereditary ocular disease
  • •pregnancy

研究组 & 干预措施

BSS arm

Active Comparator

BSS is given at the end of surgery

干预措施: BSS arm (Procedure)

air arm

Experimental

air-tamponade is given at the end of surgery

干预措施: air arm (Procedure)

结局指标

主要结局

resorption of intraretinal cystoid changes after surgery

时间窗: 3 months

occurrence of intraretinal cystoid changes will be diagnosed by OCT

次要结局

未报告次要终点

研究者

发起方
Vienna Institute for Research in Ocular Surgery
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prim. Prof. Dr. Oliver Findl, MBA

Prim. Prof. Dr. Oliver Findl, MBA

Vienna Institute for Research in Ocular Surgery

研究点 (1)

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