A Study to Compare the Effectiveness of Using Tints or Thin-Films on Eye Glass Lens to Reduce Light Sensitivity for Patients with Chronic Migraine

Overview

About this study

The purpose of this study is to compare eye glass lenses that have been treated with tints, to lenses that have been treated with thin-films to reduce light sensitivity and headache in patients who have chronic migraine. It is unknown if there is an advantage to either spectacle lens treatment. Both treatments could be a novel, non-invasive addition in the treatment of chronic migraine.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • 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)
  • Subjects must be between the ages of 18 and 80 years old.
  • Must be stable on current migraine treatment regimen
    • Stability is defined as no major changes in therapy contemplated within the next 4 months

Exclusion Criteria

  • Other light sensitive conditions, such as iritis and blepharospasm
  • Best-corrected visual acuity less than 20/40 
  • Diseases of the retina, such as diabetic retinopathy and macular degeneration.
  • Use of medications known to affect the eye (e.g. chloroquine, hydroxychloroquine, ethambutol, amiodarone)
  • Due to constraints on the manufacture and mounting of study lenses into frames, the study must exclude anyone very nearsighted (more than 4 diopters),  very farsighted (more than 2 diopters), has more than 2.5 diopters of astigmatism
  • Must not have had any botulinum toxin injections or other nerve block treatments within 4 months of enrollment, and can not receive any further blocks until the study is completed because of the cyclical effects on patients undergoing these treatments
  • Continuous daily headache (a headache frequency of 100%) or do not have a headache frequency of at least 50%
  • Has medication overuse headaches 
    • A history of medication overuse who has not overused abortive medications for the past 4 months can be included
  • Abuses alcohol or uses illicit drugs
  • Considered to be from vulnerable populations, including pregnant women, prisoners, mentally disabled, has cognitive or decisional impairment, or is a ward of the state

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rashmi Halker Singh, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20265560

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