Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- HIT-6 Score
研究概览
简要总结
The purpose of this study is to determine if a special coating, applied to the surface of glasses can reduce the frequency and severity of migraine headaches in children and adolescents. This study is being conducted by researchers at Primary Children's Medical Center, The John Moran Eye Center, and the University of Utah Department of Electrical Engineering. The investigators have determined that a specific frequency of light is particularly bothersome to migraine patients. The coating they've developed is designed to block this frequency of light. Very few treatments are approved for the treatment of childhood migraine. The investigators hope that these glasses will provide a safe way to improve headaches in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, 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 at least 10 headache days per month
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, albinism
- •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 Score
时间窗: 12 weeks
The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician.
次要结局
未报告次要终点