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

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Scottsdale/Phoenix, Arizona: 16-004992
    NCT ID: NCT02720211
    Sponsor Protocol Number: 86498

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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)
  • All subjects must be between the ages of 18 and 60
  • 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 us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rashmi Halker Singh, M.D.

Open for enrollment

Contact information:

Saran Vaughn

(480)342-6487

Vaughn.Saran@mayo.edu

.
CLS-20265560

Mayo Clinic Footer