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

NCT01942486 | Terminated Results

• 1 other identifier: IRB_00065178
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders; Photophobia

Keywords

migraine; photophobia; light sensitivity; melanopsin cells; intrinsically photosensitive retinal ganglion cells

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Investigational Coating

EXPERIMENTAL

Device: Investigational Coating

Interventions

Investigational Coating DEVICE

Investigational Coating

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Primary Children's Hospital: collaborator

Study Sites (1)

Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Photophobia

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bradley Katz
• Organization: University of Utah

bradley.katz@hsc.utah.edu

8015871079

Study Officials

• Bradley Katz, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: June 14, 2013
• First Posted: September 16, 2013
• Study Start: January 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 9, 2022
• Results First Posted: March 26, 2020

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)