Pilot Study on the Effect of Low Strength Pilocarpine in Reducing Migraine Associated Disability and Photophobia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To assess the impact of the 0.125% pilocarpine drops in reducing migraine-related disability using HIT-6 (Headache Impact Test) scores and MIDAS (Migraine Disability Assessment) scores.
研究概览
简要总结
Migraine is one of the oldest reported diseases and the second most disabling disease worldwide.It affects almost 1.1 billion people worldwide and is a major cause of morbidity and disability specially in the young population. In 80 % of migraine attacks, photophobia or light sensitivity is a core component.
The literal meaning of photophobia is fear of light. The exact cause of photophobia in migraine is not yet known and a number of causes have been postulated like cortical hypersensitivity to light, altered ocular parasympathetic outflow, and intrinsically photosensitive retinal ganglion cell pathways acting on dura-sensitive thalamocortical neurons which in turn can influence pupillary light reflexes.
Recently the author reported that the patients of migraine with photophobia have a larger pupil size as compared to patients with no history of migraine and that the severity of headache correlates with a larger pupil size.
In this study we checked the pupil sizes in patients of severe migraine with photophobia, the effect of 0.125% pilocarpine eye drops on the pupil sizes and whether the drops could help reduce photophobia which is a major trigger for the migraine attacks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 15.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants meeting ICD 3 criteria for migraine Participants having migraine with photophobia with light as the trigger factor for migraine Patients with BCVA of 6/6 Patients with normal anterior and posterior segment and normal IOP Patients with normal neurological assessment and normal MRI Patients volunteering to answer physicians questionnaire on HIT 6 and MIDAS.
排除标准
- •Participants with no associated neurological disorder.
- •Participants with no pre existing ocular conditions affecting pupil size.
- •Participants with no recent eye surgeries.
- •Participants not on any medications which can affect pupil size.
结局指标
主要结局
To assess the impact of the 0.125% pilocarpine drops in reducing migraine-related disability using HIT-6 (Headache Impact Test) scores and MIDAS (Migraine Disability Assessment) scores.
时间窗: Day 0, Day 30 (HIT-6 scores), Day 90 (MIDAS Scores)
次要结局
- To evaluate the effect of 0.125% pilocarpine on the pupil sizes of migraine patients with photophobia.(Day 30, Day 90)
研究者
Ruby Moharana
Apex Eye Care