Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- HIT-6
研究概览
简要总结
Approximately 9% of men and 18% of women suffer from migraine headaches. Almost all migraine sufferers report light sensitivity during a headache. Some people with migraine report that light can trigger their migraines and some people with migraine are light sensitive all of the time. The investigators have recently determined that certain colors of light are more likely to trigger migraines than other colors. In this study the investigators want to know if people who wear glasses that block these colors of light will have fewer migraine headaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be diagnosed with migraine with aura or migraine without aura
- •Must have chronic daily migraine (at least 15 headache days per month)
- •Age 18 or older
排除标准
- •Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
- •Unwilling or unable in the judgment of the investigator to complete the study
- •Unavailable for any of the study visits
- •Light sensitive conditions: meningitis, iritis, blepharospasm
- •Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
- •Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
- •Best corrected visual acuity less than 20/40 in either eye
结局指标
主要结局
HIT-6
时间窗: 10 weeks
Primary outcome measure is improvement in HIT-6 while wearing therapeutic lenses compared to baseline. The HIT-6 is the Headache Impact Test, a trademarked and copyrighted test (2001 QualityMetric, Inc. and GlaxoSmithKline Group of Companies)
次要结局
- Headache frequency and severity(10 weeks)
研究者
Bradley Katz
Associate Professor of Ophthalmology & Neurology
University of Utah