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This will be a randomized double blind cross over interventional trial to determine if Avulux lenses are able to reduce headache symptoms in patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avulux Lenses | Experimental | This group will be receiving migraine treatment using Avulux lenses |
|
| Placebo Lenses | Placebo Comparator | This group will be using identical placebo lenses as treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avulux Lenses | Device | Avulux lenses are specialized eyewear designed to reduce specific wavelengths of light to alleviate symptoms in individuals who experience light sensitivity and migraines |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leslie Aragon, MPH | Contact | 323-812-5569 | Leslie.A.Aragon@kp.org | |
| Munish Sharma, OD/MBA | Contact | 909-427-4452 | Munish.Sharma@kp.org |
| Name | Affiliation | Role |
|---|---|---|
| Munish Sharma, OD/MBA | Kaiser Permanente | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37150129 | Background | 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. | |
| 26875996 | Background |
| Label | URL |
|---|---|
| Avulux Migraine and Light Sensitivity Pilot Study Published in the Journal of Clinical Neuroscience | View source |
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Participant data will not be shared
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| D020795 | Photophobia |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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.
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Neither the participants or the researchers will know which treatment is being received during the trial. This will be achieved by using identical looking placebos for control and ensuring all aspects of the treatment administration and assessment are indistinguishable.
| Placebo Lenses | Device | Lenses that will look identical to Avulux lenses without the medical benefits |
|
| 6 months |
| 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. |
| 2062542 | Background | 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. |
| 21622479 | Background | 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. |
| Avulux Randomized Trial | View source |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D005128 | Eye Diseases |