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

Migraine Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01942486
• Other study ID #: IRB_00065178
• Status: Terminated
• Phase: N/A
• Start date: January 2014
• Est. completion date: April 2018

Study information

• Verified date: November 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Must be diagnosed with migraine with aura or migraine without aura

2. Must have at least 10 headache days per month

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

Related Conditions & MeSH terms

• Headache
• Hypersensitivity
• Migraine Disorders
• Photophobia

Intervention

Device:
• Investigational Coating

Locations

Country	Name	City	State
United States	Moran Eye Center	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Primary Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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