跳至主要内容
临床试验/NCT00869141
NCT00869141已完成4 期

Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
52
试验地点
1
主要终点
Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma

研究概览

简要总结

The purpose of this study is to compare the occurrence rate of the high pressure phase and the final pressure outcomes between patients treated with glaucoma medication prior to the expected onset of the high pressure phase to those patients who have glaucoma medication started at the onset of the high pressure phase. The investigators hypothesize that if glaucoma medications are started prior to the expected onset of high pressure phase, the high pressure phase will not occur as frequently and the ultimate pressure level will be lower than if the glaucoma medications are started at the onset of this phase.

详细描述

Tube shunt procedures are a popular surgery for the control of glaucoma. Tube shunt devices are designed to drain eye fluid (aqueous humor) through a tube inserted into the front chamber of the eye (anterior chamber) to a plate secured to the mid-posterior section of the outer eyeball wall. The body then lays down collagen tissue and forms a capsule around the plate. The fluid filters through the capsule of collagen tissue and is reabsorbed into the ocular and systemic circulation. The collagen tissue continues to remodel itself over a long period of time (up to years). However, a well characterized, yet poorly understood, phenomenon occurs in many patients in the 4-8 weeks after the device's implantation, called the hypertensive phase. The pressure of the eye can increase from a desirable level of about 10 immediately after the tube shunt implantation to much higher levels, in the range of 20 to 30's, and then it may gradually return to less than 20. Such a high pressure phase can cause irreversible damage an eye with glaucoma. The usual management of a high pressure phase is to start glaucoma medications as soon as it is detected. A previous study we conducted showed that this high pressure phase resolves in about half of patients with medical therapy, but the other half may continue to have higher than expected pressures. The exact cause of this high pressure phase is unknown. However, it is postulated that the mechanism may involve a compaction collagen tissue layers under the eye's own fluid pressure while the collagen tissue is being laid down, which in turn creates a firm, dense capsule that makes escape of fluid difficult. Therefore, it is argued that if the formation of eye fluid is reduced by medication during this initial period when the collagen tissue is laid down, the compaction of collagen, and subsequently the high pressure phase may be avoided.

The purpose of this study is to compare the occurrence rate of the high pressure phase and the final pressure outcomes between patients treated with glaucoma medication prior to the expected onset of the high pressure phase to those patients who have glaucoma medication started at the onset of the high pressure phase. We hypothesize that if glaucoma medications are started prior to the expected onset of high pressure phase, the high pressure phase will not occur as frequently and the ultimate pressure level will be lower than if the glaucoma medications are started at the onset of this phase.

We believe that this study will have a very significant impact on the management of glaucoma with tube shut procedures. If it is true that the rate and pressure level of the hypertensive phase can be reduced by simply starting glaucoma medications to reduce the formation of eye fluid before the expected the high pressure phase begins, which is generally 4 weeks after implantation of the tube shunt device, glaucoma patients can be saved from exposure to the very high level of eye pressure, and the eventual pressure control may be better.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients requiring Ahmed glaucoma valve implantation to control intraocular pressure between the ages of 18 and 85 years.

排除标准

  • Unwilling or unable to give consent or unwilling to accept randomization.
  • Patient out of area and potentially unavailable for follow-up visits.
  • Known allergic reaction to timolol, brimonidine, dorzolamide, brinzolamide, or sulfa drugs.
  • Known medical contraindications to the use of beta-blockers, including congestive heart failure, heart block, asthma, and chronic obstructive pulmonary disease.
  • Concurrent intraocular procedure with Ahmed glaucoma valve implantation
  • Previous Ahmed glaucoma valve implantation

研究组 & 干预措施

Research arm (postop IOP>10)

Experimental

Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation

干预措施: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide) (Drug)

Standard of care arm (postop IOP>17)

Active Comparator

Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation

干预措施: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide) (Drug)

结局指标

主要结局

Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma

时间窗: within 6 months after surgery

Intraocular pressure more than 21 mmHg during the first 6 months after Ahmed valve implantation after the pressure has been reduced to less than 22 mmHg in the first postoperative week

Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma

时间窗: 3 weeks after surgery

intraocular pressure comparison between groups after the Ahmed valve implantation

Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase

时间窗: 1 year after surgery

intraocular pressure of eyes with hypertensive phase versus without hypertensive phase

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

Simon Law

Clinical Associate Professor of Health Sciences

University of California, Los Angeles

研究点 (1)

Loading locations...

相似试验