We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spectacle Tints and Thin-Films for Migraine

This study is currently recruiting participants.
Verified November 2017 by Bradley Katz, University of Utah
Sponsor:
ClinicalTrials.gov Identifier:
NCT02720211
First Posted: March 25, 2016
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Axon Optics, LLC
Mayo Clinic
Brigham and Women's Hospital
Northwell Health
Information provided by (Responsible Party):
Bradley Katz, University of Utah
  Purpose
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.

Condition Intervention
Headache Migraine Chronic Device: Gray tinted spectacle lenses Device: Thin-Film spectacle lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Spectacle Tints and Thin-Films to Reduce Headache Frequency in Patients With Chronic Migraine

Resource links provided by NLM:


Further study details as provided by Bradley Katz, University of Utah:

Primary Outcome Measures:
  • Headache frequency [ Time Frame: one month ]
    proportion of days with at least one headache lasting at least 4 hours


Secondary Outcome Measures:
  • Headache Impact [ Time Frame: one month ]
    Headache impact as measured by the headache impact test (HIT-6)


Estimated Enrollment: 140
Study Start Date: August 2016
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gray tinted spectacle lenses
Subjects in this arm will be asked to wear a neutral gray tint that blocks all wavelengths equally
Device: Thin-Film spectacle lenses
A thin film optical notch filter designed to block 480-nm light in the visible spectrum
Experimental: Thin-Film spectacle lenses
Subjects in this arm well be asked to wear a thin-film coating that specifically blocks 480-nm wavelength
Device: Gray tinted spectacle lenses
A neutral gray optical tint designed to block all wavelengths in the visible spectrum

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02720211


Contacts
Contact: Bradley Katz, MD 8015856653 bradley.katz@hsc.utah.edu
Contact: Yaira Garzon, MD 985-429-1139 yaira.garzon@ecresearch.org

Locations
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Isabel Santana    480-342-2942    Santana.Isabel@mayo.edu   
Contact: Marie Clarkson, MHA,CCRP    480-342-4051    Clarkson.Marie@mayo.edu   
Principal Investigator: Rashmi B Halker-Singh, MD         
United States, Massachusetts
Brigham and Women's Hospital; John R Graham Headache Center; Harvard University, Recruiting
Boston, Massachusetts, United States, 02130
Contact: Melissa Darsey, PA-C    617-983-7580    mdarsey@bwh.harvard.edu   
Principal Investigator: Paul Rizzoli, MD         
United States, New York
Headache Center of the Neuroscience Institute; Hofstra Northwell Health; Northshore University Hospital Recruiting
Great Neck, New York, United States, 11021
Contact: Melissa Eng    516-881-7046    meng2@northwell.edu   
Contact: Connie Lau    516-881-7046    CLau@northwell.edu   
Principal Investigator: Noah Rosen, MD         
United States, Utah
John A Moran Eye Center; University of Utah Hospitals and Clinics Recruiting
Salt Lake City, Utah, United States, 84132
Principal Investigator: Bradley J Katz, MD         
Sponsors and Collaborators
University of Utah
Axon Optics, LLC
Mayo Clinic
Brigham and Women's Hospital
Northwell Health
Investigators
Principal Investigator: Bradley Katz, MD Axon Optics, LLC
  More Information

Responsible Party: Bradley Katz, MD, PhD, University of Utah
ClinicalTrials.gov Identifier: NCT02720211     History of Changes
Other Study ID Numbers: IRB #86498
First Submitted: March 21, 2016
First Posted: March 25, 2016
Last Update Posted: November 16, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bradley Katz, University of Utah:
headache
photophobia
migraine
light sensitivity
tints
thin films

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms