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

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Rashmi Halker Singh, M.D.

Cerrado para la inscripción

More information

Publicaciones

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CLS-20265560

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