Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if a special coating, applied to the surface of glasses can reduce the frequency and severity of migraine headaches in children and adolescents. This study is being conducted by researchers at Primary Children's Medical Center, The John Moran Eye Center, and the University of Utah Department of Electrical Engineering. The investigators have determined that a specific frequency of light is particularly bothersome to migraine patients. The coating they've developed is designed to block this frequency of light. Very few treatments are approved for the treatment of childhood migraine. The investigators hope that these glasses will provide a safe way to improve headaches in children.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational Coating
|
Device: Investigational Coating
|
Outcome Measures
Primary Outcome Measures
- HIT-6 Score [12 weeks]
The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Must be diagnosed with migraine with aura or migraine without aura
-
Must have at least 10 headache days per month
Exclusion Criteria:
-
Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
-
Pregnant
-
Unwilling or unable in the judgment of the investigator to complete the study
-
Unavailable for any of the study visits
-
Light sensitive conditions: meningitis, iritis, blepharospasm, albinism
-
Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
-
Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
-
Best corrected visual acuity less than 20/40 in either eye
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moran Eye Center | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- University of Utah
- Primary Children's Hospital
Investigators
- Principal Investigator: Bradley Katz, MD, University of Utah
Study Documents (Full-Text)
More Information
Publications
None provided.- IRB_00065178
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Investigational Coating |
|---|---|
| Arm/Group Description | Subjects will be randomized to wear an investigational coating on their glasses |
| Period Title: Overall Study | |
| STARTED | 35 |
| COMPLETED | 8 |
| NOT COMPLETED | 27 |
Baseline Characteristics
| Arm/Group Title | Investigational Coating |
|---|---|
| Arm/Group Description | Investigational Coating |
| Overall Participants | 35 |
| Age (Count of Participants) | |
| <=18 years |
35
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
13
(3.5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
20
57.1%
|
| Male |
15
42.9%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
0
0%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
35
100%
|
| Region of Enrollment (participants) [Number] | |
| United States |
35
100%
|
Outcome Measures
| Title | HIT-6 Score |
|---|---|
| Description | The HIT-6 (Headache Impact Test) is a validated measure of the impact of headache on activities of daily living, functional health and well-being. The minimum score is 36 and the maximum score is 78. The higher the score, the more your headaches are adversely affecting activities of daily living. Patients who score higher than 50 are encouraged to seek help from their physician. |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only subjects that completed the trial were analyzed |
| Arm/Group Title | Investigational Coating |
|---|---|
| Arm/Group Description | Subjects will wear an investigational coating on their eyeglasses to reduce headache frequency |
| Measure Participants | 8 |
| Mean (Standard Deviation) [units on a scale] |
62.3
(4.8)
|
Adverse Events
| Time Frame | 3 years | |
|---|---|---|
| Adverse Event Reporting Description | This was a minimal risk study with no risk of mortality and no risk of a serious adverse even | |
| Arm/Group Title | Investigational Coating | |
| Arm/Group Description | Subjects were asked to wear an investigational coating on their eyeglasses to reduce their headache severity | |
All Cause Mortality |
||
| Investigational Coating | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/35 (0%) | |
Serious Adverse Events |
||
| Investigational Coating | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/35 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Investigational Coating | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/35 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Bradley Katz |
|---|---|
| Organization | University of Utah |
| Phone | 8015871079 |
| bradley.katz@hsc.utah.edu |
- IRB_00065178