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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01942486
Recruitment Status : Terminated
First Posted : September 16, 2013
Results First Posted : March 26, 2020
Last Update Posted : November 9, 2022
Sponsor:
Collaborator:
Primary Children's Hospital
Information provided by (Responsible Party):
Bradley Katz, University of Utah

Study Description
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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.

Condition or disease Intervention/treatment Phase
Migraine Disorders Photophobia Device: Investigational Coating Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Study Start Date : January 2014
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Investigational Coating Device: Investigational Coating


Outcome Measures
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Primary Outcome Measures :
  1. HIT-6 Score [ Time Frame: 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942486


Locations
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United States, Utah
Moran Eye Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Primary Children's Hospital
Investigators
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Principal Investigator: Bradley Katz, MD University of Utah
  Study Documents (Full-Text)

Documents provided by Bradley Katz, University of Utah:
Study Protocol  [PDF] July 17, 2013
Informed Consent Form: Parental Permission Form  [PDF] May 17, 2017
Informed Consent Form: Assent Form  [PDF] May 17, 2017
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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Responsible Party: Bradley Katz, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01942486    
Other Study ID Numbers: IRB_00065178
First Posted: September 16, 2013    Key Record Dates
Results First Posted: March 26, 2020
Last Update Posted: November 9, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bradley Katz, University of Utah:
migraine
photophobia
light sensitivity
melanopsin cells
intrinsically photosensitive retinal ganglion cells
Additional relevant MeSH terms:
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Migraine Disorders
Photophobia
Hypersensitivity
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Vision Disorders
Sensation Disorders
Eye Diseases