Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine

Study Overview
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Brief Summary
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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.

Official Title
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Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine

Conditions
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Migraine Disorders, Photophobia

Intervention / Treatment
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* Device: Investigational Coating


Participation Criteria
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Eligibility Criteria
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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 Pregnant 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Coating<br> | Device: Investigational Coating<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIT-6 Score | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, photophobia, light sensitivity, melanopsin cells, intrinsically photosensitive retinal ganglion cells