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
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. 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