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.
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)
