Migraine Headache Mitigation Utilizing Avulux
Study Details
Study Description
Brief Summary
This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Participants:
This study will include a total of 40 participants aged 18 and over who have been screened for migraine headache history. Patients who attended the SBC Headache class with a diagnosis of Migraine from the last 12 months will be selected and assigned a number. Random number set will be used to select the 40 patients. Additional 40 patients will be selected to meet the total initial enrollment of 40 patients in the end. These 40 patients will be randomly assigned to Avulux or Control groups. Each patient will be assigned a unique identifier, and the rest of the correspondents will not use patient demographics.
Design:
The study will be a randomized, double blind, crossover interventional trial. Participants will be randomly assigned to one of 2 groups of 20. 1. Experimental Group: Participants in this group will wear Avulux lenses during the testing sessions. 2. Control Group: Participants in this group will wear placebo lenses that resemble Avulux lenses but do not have the same optical properties.
Procedure:
Participants will complete a baseline assessment and self-report migraine frequency using the Redcap migraine diary application. Participants will complete testing sessions with both Avulux and placebo lenses for the duration of 3 months and then switch lenses for the remaining 3 months for comparison and a total study period of 6 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Avulux Lenses This group will be receiving migraine treatment using Avulux lenses |
Device: Avulux Lenses
Avulux lenses are specialized eyewear designed to reduce specific wavelengths of light to alleviate symptoms in individuals who experience light sensitivity and migraines
Device: Placebo Lenses
Lenses that will look identical to Avulux lenses without the medical benefits
|
| Placebo Comparator: Placebo Lenses This group will be using identical placebo lenses as treatment |
Device: Avulux Lenses
Avulux lenses are specialized eyewear designed to reduce specific wavelengths of light to alleviate symptoms in individuals who experience light sensitivity and migraines
Device: Placebo Lenses
Lenses that will look identical to Avulux lenses without the medical benefits
|
Outcome Measures
Primary Outcome Measures
- Reduction in migraine frequency [6 months]
headache days per month documented in a headache diary.
- Reduction in migraine severity [6 months]
Severity of headaches on a scale from no, mild, moderate, and sever pain
Secondary Outcome Measures
- Improve quality of life [6 months]
Rating of daily activity performance using Functional Disability Scale (0) No disability-(6) Severe disability
- Medication Use [6 months]
Number of medications used as a form of rescue medication during episode of migraine
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient population: Individuals must have an existing diagnosis code of G43.1 (migraine w aura) or G43. 10 (migraine w aura, not intractable).
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Only Kaiser Permanente members receiving care at the Fontana Medical Service Areas will be in consideration.
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Patients that are >18
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There will no restrictions based on biological sex.
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Participants will be referred to optical by provider (Neurologists/Optometrist/Primary Care physician).
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Participants must agree to not initiate any new medical management during the trial or be willing to voluntarily withdrawal from participating in the trial
Exclusion Criteria:
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Patients who do not have a migraine diagnosis code in their medical record.
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Patients that have started a new migraine medication within last 30 days
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Non-Members of Kaiser Permanente
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kaiser Permanente
Investigators
- Principal Investigator: Munish Sharma, OD/MBA, Kaiser Permanente
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Avulux Migraine and Light Sensitivity Pilot Study Published in the Journal of Clinical Neuroscience
- Avulux Randomized Trial
Publications
- Huang J, Zong X, Wilkins A, Jenkins B, Bozoki A, Cao Y. fMRI evidence that precision ophthalmic tints reduce cortical hyperactivation in migraine. Cephalalgia. 2011 Jun;31(8):925-36. doi: 10.1177/0333102411409076. Epub 2011 May 26.
- Katz BJ, Digre KB. Diagnosis, pathophysiology, and treatment of photophobia. Surv Ophthalmol. 2016 Jul-Aug;61(4):466-77. doi: 10.1016/j.survophthal.2016.02.001. Epub 2016 Feb 12.
- Posternack C, Kupchak P, Capriolo AI, Katz BJ. Targeting the intrinsically photosensitive retinal ganglion cell to reduce headache pain and light sensitivity in migraine: A randomized double-blind trial. J Clin Neurosci. 2023 Jul;113:22-31. doi: 10.1016/j.jocn.2023.04.015. Epub 2023 May 5.
- Wilkins AJ, Wilkinson P. A tint to reduce eye-strain from fluorescent lighting? Preliminary observations. Ophthalmic Physiol Opt. 1991 Apr;11(2):172-5. doi: 10.1111/j.1475-1313.1991.tb00217.x.
- Avulux