跳至主要内容
临床试验/NCT01468103
NCT01468103Unknown不适用

Laser Peripheral Iridotomy Versus Surgical Peripheral Iridectomy in Early Angle Closure:a Randomized Clinical Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
intraocular pressure

研究概览

简要总结

This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI) and surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up for 3 years.

详细描述

The following will be studied:

  1. To evaluate the safety of these two techniques for the treatment of angle closure.
  2. To compare the anterior chamber reaction and IOP changes post surgery.
  3. TO establish the UBM/ASOCT chamber angle parameters changes pre and post surgery.
  4. To assess the development of PAS.

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
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • more than 50 years old
  • Diagnosis of either: Primary angle closure suspects, Primary angle closure in need of laser iridotomy or surgical iridectomy
  • Able to give Informed concent

排除标准

  • Ophthalmic diseases other than glaucoma and cataract
  • pseudophakic or aphakic patients
  • inability to attend regular follow-up assessment or to give informed written consent
  • Secondary causes of angle closure e.g. subluxed lens, uveitis, trauma and neovascular glaucoma
  • Participating in another study
  • monocular patients

结局指标

主要结局

intraocular pressure

时间窗: 3 years

次要结局

  • Angle assessment parameters(3 years)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao Xinbo

student

Sun Yat-sen University

研究点 (1)

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