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

Bradley Katz

Status: Completed

Conditions: Photophobia; Migraine Disorders

Treatments: Other: Therapeutic Lens Coating; Other: Sham Lens Coating

Study type: Interventional

Funder types: Other

Identifiers

NCT01828684

IRB_00047263

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

48 participants in 2 patient groups

Therapeutic Lens Coating

Experimental group

Description:

Subjects will wear a therapeutic lens coating for 2 weeks

Treatment:

Other: Therapeutic Lens Coating

Other: Sham Lens Coating

Sham Lens Coating

Sham Comparator group

Description:

Subjects will wear a sham lens coating for 2 weeks

Treatment:

Other: Therapeutic Lens Coating

Other: Sham Lens Coating