Back to resultsThin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Primary Purpose
Migraine Disorders, Photophobia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigational Coating
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Disorders focused on measuring migraine, photophobia, light sensitivity, melanopsin cells, intrinsically photosensitive retinal ganglion cells
Eligibility Criteria
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
Sites / Locations
- Moran Eye Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigational Coating
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01942486
First Posted
June 14, 2013
Last Updated
November 6, 2022
Sponsor
University of Utah
Collaborators
Primary Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01942486
Brief Title
Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Official Title
Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Primary Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders, Photophobia
Keywords
migraine, photophobia, light sensitivity, melanopsin cells, intrinsically photosensitive retinal ganglion cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational Coating
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Investigational Coating
Primary Outcome Measure Information:
Title
HIT-6 Score
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Katz, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
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