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临床试验/NCT01814514
NCT01814514Unknown2 期

Early Intra Ocular- Pressure Control Using Aqueous Suppressive Agents After Ahmed Glaucoma Valve Implantation

Zahra Rabbani Khah1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2011年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
94
试验地点
1
主要终点
intraocular pressure-hypertensive phase success rate

研究概览

简要总结

The AGV implant is designed to open when the IOP is between 8 mmHg and 10 mmHg, and thus maintains an IOP of 8 mmHg or higher. In the early period after glaucoma drainage device (GDD) surgery the intraocular pressure (IOP) classically goes through 2 phases. The hypotensive phase occurs immediately after surgery, lasts around 1 week. This is followed by the hypertensive period where the IOP tends to rise steadily above 21mmhg.

The hypertensive response seems to occur more commonly after Ahmed GDD surgery than nonvalved implants, It was reported to occur in 40% to 80% of cases. Although the hypertensive phase can last as long as 6 months it is usually during the first 1 to 4 weeks, when there is intense congestion of the bleb wall, that IOP is highest.

Previous study showed that when aqueous comes into contact with conjunctiva and Tenon's capsule,an inflammatory reaction occurs.Factors such as prostaglandins, eicosanoids, tissue growth factor beta (TGF β)has been shown to occur in glaucomatous aqueous. These mediators induce an inflammatory reaction, and if excessive, will result in fibrosis and poor functioning of the bleb. High pressure within the bleb also results in the secretion of TGF β by the bleb lining. It may result in inflammation of the bleb wall and subsequent fibrosis and poor bleb function. The investigators supposed that with early use of aqueous suppressant medication after AGV implantation, the concentration of inflammatory mediators decreased in subconjunctival space and may lead to better IOP control after shunt 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
Double (Participant, Investigator)

入排标准

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

入选标准

  • patients with uncontrolled glaucoma requiring AGV device implantation.

排除标准

  • History of AGV implantation
  • Allergy to Anti glaucoma medication
  • unable to come for follow up
  • Known contraindication to beta blacker such as asthma- chronic obstructive pulmonary disease (COPD). Heart failure heart block
  • Learning difficulty- mental illness or severely ill

研究组 & 干预措施

Timolol-trusopt

Active Comparator

Dosage:One drop/12hours,duration:3 months

干预措施: Timolol-trusopt (Drug)

placebo,Artificial tear

Placebo Comparator

dosage:one drop/12 hours,duration:3 months

干预措施: placebo (Drug)

结局指标

主要结局

intraocular pressure-hypertensive phase success rate

时间窗: during first 3 months

during first 3 months

次要结局

  • intraocular pressure success rate(after 12 months)

研究者

发起方
Zahra Rabbani Khah
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zahra Rabbani Khah

ophthalmologist

Shahid Beheshti University of Medical Sciences

研究点 (1)

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