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临床试验/NCT02474225
NCT02474225已完成不适用

Intraocular Pressure Change Following Intravitreal Injection of Anti-vascular Endothelial Growth Factor Agent

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年12月最近更新:
适应症
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 from baseline in intraocular pressure

研究概览

简要总结

The introduction of additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause an immediate rise in the intraocular pressure. This transient, short-term intraocular pressure elevation (lasting up to 30 minutes) after intravitreal anti-vascular endothelial growth factor therapy has been well describe. The investigators aim to study the prevalence of the sustained intraocular pressure elevation associated with intravitreal injection of anti-vascular endothelial growth factor agents.

详细描述

Intravitreal injections of anti-vascular endothelial growth factor agents are commonly used to treat a variety of retinal and choroidal neovascular diseases. The introduction of additional fluid into the vitreous cavity by intravitreal therapy would be expected to cause an immediate rise in the intraocular pressure.

Although there is one study showed no significant changes in the intraocular pressure many retrospective studies showed the impacts on the intraocular pressure elevation. The investigators aim to prospective evaluate the intraocular pressure change in non-glaucomatous patients receiving an intravitreal anti-vascular endothelial growth factor therapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled to receive intravitreal injection of anti-vascular endothelial growth factor agent (either bevacizumab or ranibizumab), and
  • Age of 18-85 year-old, and
  • Initial intraocular pressure < 21 mmHg

排除标准

  • Diagnosis of open angle, or
  • Diagnosis of angle-closure glaucoma, or
  • Diagnosis of glaucoma suspect (intraocular pressure > 21 mmHg on 2-consecutive visit and/or cup to disc ratio > 0.5) , or
  • Currently receive systemic beta-blocker
  • Previously received intravitreal injection of anti-vascular endothelial growth factor agent
  • Previously received intravitreal injection of steroid or gancyclovir
  • Current use of steroid eye drop
  • Any ocular surface disease preclude a reliable intraocular pressure measurement

结局指标

主要结局

Change from baseline in intraocular pressure

时间窗: 6-month after injection

intraocular pressure change at 6-month after injection

次要结局

  • Number of anti-glaucoma used(6-month)

研究者

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

Weerawat Kiddee

Asst. Prof.

Prince of Songkla University

研究点 (1)

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