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临床试验/CTRI/2011/11/002105
CTRI/2011/11/002105已完成4 期

A comparative study on safety & efficacy of travoprost & brimonidine/timolol fixed combination in patients of primary open angle Glaucoma at ophthalmology department of Peoples College of Medical Sciences & Research Centre BhanpurBhopal.

未提供1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年8月11日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
70
试验地点
1
主要终点
Perimetry

研究概览

简要总结

•Glaucoma--------Second leading cause of blindness, silent thief of sight.

•   Progressive optic neuropathy with degeneration of

retinal ganglion cells.

•   Irreversible blindness if left undiagnosed & untreated

•   Normal IOP ® 10-20mm Hg.

•

Data from the Early Manifest Glaucoma Trial (EMGT) have shown that an additional 1 mm Hg of IOP lowering reduces the risk of glaucoma progression by 10 %.•At the baseline visit, patients will be randomized into 2 groups after investigations and diagnosis•12.3% of total blindness

•

•Vision loss range from 5.2 to 6.7 million

•

•Prevalence-1% to 4% in people over 40yrs in Asia

•

•¯ in IOP delays damage to optic nerve & visual field

•

•¯ in IOP by 30% ¯ disease progression from ~35 to 10%   .

Travoprost is will be given to one group

& Brimonidine + timolol  to another group

• Follow-up to be done - at 2, 4, 12 wks.

•IOP measurement & fundus examination will be done at every visit.

•Perimetery will be repeated  monthly.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • IOP in each eye more than 21 mm Hg. Best corrected visual acuity 6/18 or better in each eye.

排除标准

  • Progressive or functionally significant visual fields loss within past year.
  • Pregnant women or lactating mothers.
  • Patients with corneal abnormalities or any other conditions that prevent applanation tonometry.
  • Patients with ocular infection, advanced cataract, ocular inflammation.
  • Patients of bronchial asthma & cardiac disease.

结局指标

主要结局

Perimetry

时间窗: 4, 8, 12 wks

Visual acuity

时间窗: 4, 8, 12 wks

IOP

时间窗: 4, 8, 12 wks

Slit lamp Bimicroscopy for optic disc evaluation

时间窗: 4, 8, 12 wks

Gonioscopy

时间窗: 4, 8, 12 wks

次要结局

  • Visual acuity(IOP)

研究者

发起方
未提供

研究点 (1)

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