Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection: the Effect of Pretreatment With Antiglaucoma Agents
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
- 是
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
Timolol eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection
干预措施: Timolol (Drug)
Brimonidine
Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection
干预措施: Brimonidine (Drug)
Acetazolamide
Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection
干预措施: Acetazolamide (Drug)
Mannitol
Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection
干预措施: Mannitol (Drug)
Placebo
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
Nasser Shoeibi
Assistant Professor of Ophthalmology
Mashhad University of Medical Sciences
