Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2023-12-13
2024-06-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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Avulux Lenses
This group will be receiving migraine treatment using Avulux lenses
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
Placebo Lenses
Lenses that will look identical to Avulux lenses without the medical benefits
Placebo Lenses
This group will be using identical placebo lenses as treatment
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
Placebo Lenses
Lenses that will look identical to Avulux lenses without the medical benefits
Interventions
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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
Placebo Lenses
Lenses that will look identical to Avulux lenses without the medical benefits
Eligibility Criteria
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Inclusion Criteria
* Only Kaiser Permanente members receiving care at the Fontana Medical Service Areas will be in consideration.
* Patients that are \>18
* There will no restrictions based on biological sex.
* Participants will be referred to optical by provider (Neurologists/Optometrist/Primary Care physician).
* 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
* Patients that have started a new migraine medication within last 30 days
* Non-Members of Kaiser Permanente
18 Years
120 Years
ALL
Yes
Sponsors
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Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Munish Sharma, OD/MBA
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Central Contacts
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References
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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.
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.
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.
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.
Related Links
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Avulux Migraine and Light Sensitivity Pilot Study Published in the Journal of Clinical Neuroscience
Avulux Randomized Trial
Other Identifiers
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Avulux
Identifier Type: -
Identifier Source: org_study_id