跳至主要内容
临床试验/NCT02140450
NCT02140450已完成不适用

Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection: the Effect of Pretreatment With Antiglaucoma Agents

Mashhad University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
change in IOP

研究概览

简要总结

To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular pressure rise after intravitreal injection.

详细描述

Acute intraocular pressure elevation after intravitreal injection of bevacizumab was proven.Acute intraocular pressure elevation most probably is volume related and long term intraocular pressure elevation relates to pharmacologic features of the medications which results in anatomic changes in the angle of anterior chamber.Numerous studies found an intraocular pressure elevation right after the injection and quick normalization within maximally 30 minutes.This intraocular pressure elevation which lasts about 30 minutes, can result in irreversible visual loss especially in patients with critical remaining nerve fibers in the optic nerve head, as occurs in glaucomatous patients. Is there any way to prevent or even shorten this time of intraocular pressure elevation? We tried in our study to find a suitable response for a question above, so we used several anti-glaucoma agents (Timolol, Brimonidine, Acetazolamide, Mannitol versus placebo) as a prophylaxis to prevent acute intraocular pressure elevation right after intravitreal bevacizumab injection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients who candidate for receiving intravitreal bevacizumab

排除标准

  • patients who had advanced glaucoma
  • patients who received antiglaucoma agents in the past
  • patients who had corneal scar which affect IOP measurement

研究组 & 干预措施

Timolol

Active Comparator

Timolol eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection

干预措施: Timolol (Drug)

Brimonidine

Active Comparator

Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection

干预措施: Brimonidine (Drug)

Acetazolamide

Active Comparator

Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection

干预措施: Acetazolamide (Drug)

Mannitol

Active Comparator

Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection

干预措施: Mannitol (Drug)

Placebo

Sham Comparator

Artificial tears, 2 drops, 1-2 hours before intravitreal injection

干预措施: Placebo (Drug)

结局指标

主要结局

change in IOP

时间窗: 0, 5, 10, 15, 30 minutes after injection

the change in intraocular pressure after intravitreal injection of bevacizumab

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nasser Shoeibi

Assistant Professor of Ophthalmology

Mashhad University of Medical Sciences

研究点 (1)

Loading locations...

相似试验