Migraine Disorders, Photophobia
Conditions
Keywords
Migraine with Aura, Migraine without Aura, Photophobia, Chronic Daily Headache
Brief summary
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.
Interventions
OTHERTherapeutic Lens Coating
Subjects will wear a therapeutic lens coating for 2 weeks.
OTHERSham Lens Coating
Each subject will wear a sham lens coating for 2 weeks.
Sponsors
Bradley Katz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIT-6 | 10 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache frequency and severity | 10 weeks | Secondary outcome is reduction in headache frequency and severity as assessed by headache diaries. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Photophobia | 10 weeks | Tertiary outcome is reduction in photophobia as assessed by a photophobia questionnaire. |
Countries
United States
Outcome results
None listed