Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
NCT ID: NCT01942486
Last Updated: 2022-11-09
Study Results
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View full resultsBasic Information
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TERMINATED
NA
35 participants
INTERVENTIONAL
2014-01-31
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Investigational Coating
Investigational Coating
Interventions
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Investigational Coating
Eligibility Criteria
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Inclusion Criteria
2. Must have at least 10 headache days per month
Exclusion Criteria
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
7 Years
18 Years
ALL
No
Sponsors
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Primary Children's Hospital
OTHER
University of Utah
OTHER
Responsible Party
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Bradley Katz
M.D.
Principal Investigators
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Bradley Katz, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Moran Eye Center
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form: Parental Permission Form
Document Type: Informed Consent Form: Assent Form
Other Identifiers
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IRB_00065178
Identifier Type: -
Identifier Source: org_study_id
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