Thin Film Coatings for Migraine

Principal Investigator: Bradley Katz
Keywords: migraine , photophobia , light sensitivity , headache Department: Ophthalmology-Services
IRB Number: 00086498 Co Investigator: Kevin Brennan
Specialty: Neurology, Neurology, Ophthalmology, Ophthalmology, Neurology, Neurology
Sub Specialties: Traumatic Brain Injury, Migraine, Comprehensive Ophthalmology, Neuro-Ophthalmology, Neuro-Ophthalmology, Headache
Recruitment Status: Recruiting

Contact Information

Katie  Farnsworth

Brief Summary

Previous research has shown that both spectacle tints and spectacle thin-films can be an effective treatment in migraine. The purpose of this study is to determine if one of these treatments, tints or thin-films, is superior to the other.

Inclusion Criteria

For inclusion, subjects must meet the International Headache Society criteria for chronic migraine (International Classification of Headache Disorders, 3rd edition (Headache Classification Committee of the International Headache Society, 2013; Figure 1A) - OR - subjects must meet the International Headache Society criteria for episodic migraine (Headache Classification Committee of the International Headache Society, 2013; Figure 1B) AND have at least 8 headache days per month ("high-frequency episodic migraine"). All subjects must be between the ages of 18 and 80 years-old 

To be included in the study, in the best judgment of the investigator, subjects must be stable on their current migraine treatment regimen. Stability is defined as no major changes in therapy contemplated within the next 4 months.

Subjects should be on a stable course of all prescription medications for the 4 weeks preceding enrollment.

Exclusion Criteria

Subjects with other light sensitive conditions, such as iritis and blepharospasm, will be excluded. Subjects with best-corrected visual acuity less than 20/40 will be excluded. Subjects with diseases of the retina, such as diabetic retinopathy and macular degeneration will be excluded. Subjects using medications known to affect the eye will be excluded (e.g. chloroquine, hydroxychloroquine, ethambutol, amiodarone). Due to constraints on the manufacture and mounting of study lenses into study frames, the study must exclude subjects who are very nearsighted (more than 4 diopters), subjects who are very farsighted (more than 2 diopters), and subjects who have more than 2.5 diopters of astigmatism. 

Because of the cyclical effects of botulinum toxin injections and other nerve blocks, patients undergoing these treatments will be excluded. Subjects must not have had any injections or blocks within 4 months of enrollment and should not receive any further blocks until they exit the study. 

Subjects with continuous daily headache (a headache frequency of 100%) will be excluded. Subjects who do not have a headache frequency of at least 8 days per month will be excluded. 

Subjects with medication overuse headache will be excluded (Figure 1C). A patient with a history of medication overuse who has not overused abortive medications for the past 4 months can be included. 

Subjects who abuse alcohol or use illicit drugs will be excluded.

Subjects may continue to use their customary preventative, abortive or rescue medications for migraine throughout the trial.