Spectacle Tints and Thin-Films for Migraine
Spectacle Tints and Thin-Films for Migraine
Nearly all migraine sufferers report sensitivity to light during a headache and a significant
 proportion of sufferers report light sensitivity between attacks. Light is also a common
 trigger for migraine headaches. Spectacle lenses that have been treated with tints and
 spectacle lenses that have been treated with thin-films have both been shown to reduce light
 sensitivity and headache in patients with migraine. At this time, it is not clear which
 spectacle lens treatment is superior. The purpose of this trial is to determine if there's a
 significant, therapeutic advantage to either spectacle lens treatment. Both treatments could
 be a novel, non-invasive adjuvant in the treatment of migraine.
Approximately 6% of men and 18% of women are afflicted with migraines. (Stovner et al., 2006)
 Over 90% of patients with migraines report a sensitivity to light (photophobia) during
 headaches. (Evans et al., 2008) Some migraine sufferers report that light can trigger a
 migraine and some have a chronic sensitivity to light (Main et al., 1997). Migraineurs are
 especially sensitive to non-incandescent lighting sources such as fluorescent lights,
 computer monitors, and gas-vapor lamps (Katz and Digre, 2016).

 The pathway that mediates photophobia appears to involve intrinsically photosensitive retinal
 ganglion cells ("IPRGCs"; Hattar et al., 2002) and trigeminal afferents (Noseda et al., 2010;
 Digre and Brennan, 2012). These retinal cells do not require input from photoreceptors to be
 activated by light, and they have been shown to be responsible for circadian rhythm
 entrainment and the pupillary light reflex. As such, these cells constitute a pathway
 separate from that of the visual pathway (Güler et al., 2008). IPRGCs contain the chromophore
 melanopsin. In these cells, 480 nm light (in the blue-green portion of the visible spectrum)
 isomerizes melanopsin and triggers the phototransduction cascade. However, IPRGCs can also be
 stimulated by rods and cones. Thus, IPRGCs can be stimulated directly by 480-nm light or
 indirectly by any light in the visible spectrum.

 In the present study, the investigators will use a neutral gray tint to decrease stimulation
 of the eye by all wavelengths in the visible spectrum. The investigators will compare this
 intervention to a thin-film spectacle coating designed to specifically block 480-nm light.
 The gray tint will decrease both direct and indirect stimulation of the IPRGCs by blocking
 all wavelengths of the visible spectrum. The 480-nm thin-film will specifically target direct
 stimulation of the IPRGC.

 All tints and thin films will be calibrated such that the optical density, that is the
 overall "darkness" of all study lenses, will be the same. All study lenses will appear to
 have the same overall light blocking effect to study subjects. The lenses are intended to be
 a preventative or prophylactic treatment for chronic migraine.
Inclusion Criteria:

 -  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). All subjects
 must be between the ages of 18 and 60 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.

 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 50% will be excluded.

 Subjects with medication overuse headache will be excluded. 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 considered to be
 from vulnerable populations will be excluded, including pregnant women, prisoners, subject
 who are mentally disabled, subjects with cognitive or decisional impairment, and wards of
 the state