Migraine Disorders Clinical Trial
Official title:
Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Patients With Migraine.
Verified date | March 2016 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Approximately 9% of men and 18% of women suffer from migraine headaches. Almost all migraine sufferers report light sensitivity during a headache. Some people with migraine report that light can trigger their migraines and some people with migraine are light sensitive all of the time. The investigators have recently determined that certain colors of light are more likely to trigger migraines than other colors. In this study the investigators want to know if people who wear glasses that block these colors of light will have fewer migraine headaches.
Status | Completed |
Enrollment | 48 |
Est. completion date | February 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Must be diagnosed with migraine with aura or migraine without aura 2. Must have chronic daily migraine (at least 15 headache days per month) 3. Age 18 or older 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 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | John A Moran Eye Center; University of Utah Hospitals and Clinics | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Bradley Katz |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Photophobia | Tertiary outcome is reduction in photophobia as assessed by a photophobia questionnaire. | 10 weeks | No |
Primary | HIT-6 | Primary outcome measure is improvement in HIT-6 while wearing therapeutic lenses compared to baseline. The HIT-6 is the Headache Impact Test, a trademarked and copyrighted test (2001 QualityMetric, Inc. and GlaxoSmithKline Group of Companies) | 10 weeks | No |
Secondary | Headache frequency and severity | Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries. | 10 weeks | No |
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