Migraine Headache Mitigation Utilizing Avulux

Migraine Headache Mitigation Utilizing Avulux Color Filtering Lenses

This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine; Headache; Photophobia
• Intervention / Treatment: Device: Avulux Lenses; Device: Placebo Lenses

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leslie Aragon, MPH; Phone Number: 323-812-5569; Email: Leslie.A.Aragon@kp.org
• Study Contact Backup: Name: Munish Sharma, OD/MBA; Phone Number: 909-427-4452; Email: Munish.Sharma@kp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient population: Individuals must have an existing diagnosis code of G43.1 (migraine w aura) or G43. 10 (migraine w aura, not intractable).
• 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 who do not have a migraine diagnosis code in their medical record.
• Patients that have started a new migraine medication within last 30 days
• Non-Members of Kaiser Permanente

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in migraine frequency	headache days per month documented in a headache diary.	6 months
Reduction in migraine severity	Severity of headaches on a scale from no, mild, moderate, and sever pain	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve quality of life	Rating of daily activity performance using Functional Disability Scale (0) No disability-(6) Severe disability	6 months
Medication Use	Number of medications used as a form of rescue medication during episode of migraine	6 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Investigators: Principal Investigator: Munish Sharma, OD/MBA, Kaiser Permanente

Publications and helpful links

General Publications

• 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.

Helpful Links

• Avulux Migraine and Light Sensitivity Pilot Study Published in the Journal of Clinical Neuroscience
• Avulux Randomized Trial

Study record dates

Study Major Dates

• Study Start (Estimated): December 13, 2023
• Primary Completion (Estimated): June 13, 2024
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Pain; Neurologic Manifestations; Sensation Disorders; Headache Disorders, Primary; Headache Disorders; Vision Disorders; Migraine Disorders; Headache; Photophobia
• Other Study ID Numbers: Avulux

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes