Relationship Between Topiramate Use and Ocular Angle Status: A Prospective Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including:
研究概览
简要总结
We test the hypothesis whether topiramate narrows the angles which may render Asians more likely to suffer from acute angle closure glaucoma.
详细描述
Topiramate is approved for the treatment of epilepsy and prophylaxis of migraine attacks. There were case reports of acute angle closure glaucoma (AACG) associated with its use. AACG is particularly common in Asians because of a higher prevalence of narrow angle., we test the hypothesis whether topiramate narrows the angles which may render them more likely to suffer from AACG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants aged 18-75 with an indication for starting topiramate.
排除标准
- •Patients with known allergy or intolerance to topiramate.
- •Recent exposure to topiramate (<3 months).
- •Moderate to severe renal failure.
- •Known history of renal calculi or hepatic failure
- •Inability to give informed consent.
- •Pregnant women or women of child-bearing age who do not practise an acceptable means of contraception.
- •Patients known to have angle-closure glaucoma.
结局指标
主要结局
Change(s) in ophthalmic parameters measured at baseline and after 4 weeks of treatment, including:
时间窗: 4 weeks
best-corrected visual acuity, refraction, Goldmann applanation tonometry, Gonioscopy, dilated fundus examination,
时间窗: 4 weeks
and ultrasound biomicroscopy of angle and anterior segment.
时间窗: 4 weeks
次要结局
未报告次要终点