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临床试验/NCT01417858
NCT01417858Unknown不适用

Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%

Universidade Federal do Paraná2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
intra-ocular pressure increase

研究概览

简要总结

The purpose of this study is to compare the intra-ocular (IOP) control efficacy between brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (LPI).

详细描述

Postoperative IOP elevation is one of the most common complications after LPI.Previous studies showed that brimonidine 0.2% is effective in blunting IOP spikes after LPI.This prospective randomized double-masked interventional study will include patients with bilateral narrow angles, defined by irido-trabecular contact in >180o on gonioscopy.Pilocarpine 1% will be used in both eyes, and 30 minutes later, brimonidine 0.1% randomly used in one eye and brimonidine 0.2% in the contra-lateral eye. LPI with Nd:YAG laser is performed 30 minutes later in both eyes by a single glaucoma specialist. IOP measurements are assessed before the use of any eyedrop (basal IOP), 30 minutes after pilocarpine (pre-brimonidine), and 30, 60, 120, 180 minutes after LPI. Pachymetry, ultrasonic biometry, gonioscopy, and total YAG laser energy are recorded. Non-parametric test will be used for analysis.

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • bilateral narrow angles, defined by irido-trabecular contact in >180o on gonioscopy

排除标准

  • previous cataract surgery

结局指标

主要结局

intra-ocular pressure increase

时间窗: one year

mean intra-ocular pressure increase after laser peripheral iridotomy

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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