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

Not Applicable

Terminated

• Conditions: Migraine Disorders; Photophobia
• Interventions: Device: Investigational Coating

• Registration Number: NCT01942486
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-16
• Study Start: 2014-01
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Results First Submitted: 2019-04-12
• Results First Submitted QC: 2020-03-13
• Results First Posted: 2020-03-26
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Must be diagnosed with migraine with aura or migraine without aura
2. Must have at least 10 headache days per month

Read More

Exclusion Criteria

1. Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
2. Pregnant
3. Unwilling or unable in the judgment of the investigator to complete the study
4. Unavailable for any of the study visits
5. Light sensitive conditions: meningitis, iritis, blepharospasm, albinism
6. Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
7. Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
8. Best corrected visual acuity less than 20/40 in either eye

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational Coating	Investigational Coating	-

Primary Outcome Measures

Name	Time	Method
HIT-6 Score	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.

Trial Locations

Locations (1)

Moran Eye Center; 🇺🇸 Salt Lake City, Utah, United States