Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Utah
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- HIT-6 Score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Must be diagnosed with migraine with aura or migraine without aura
- •Must have at least 10 headache days per month
Exclusion Criteria
- •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
Arms & Interventions
Investigational Coating
Intervention: Investigational Coating (Device)
Outcomes
Primary Outcomes
HIT-6 Score
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Bradley Katz
M.D.
University of Utah