Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine

NCT ID: NCT01942486

Last Updated: 2022-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine Disorders Photophobia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Investigational Coating

Group Type EXPERIMENTAL

Investigational Coating

Intervention Type DEVICE

Interventions

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Investigational Coating

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Must be diagnosed with migraine with aura or migraine without aura
2. Must have at least 10 headache days per month

Exclusion Criteria

1. Currently wearing a spectacle tint specifically prescribed for migraine or light sensitivity
2. Pregnant
3. Unwilling or unable in the judgment of the investigator to complete the study
4. Unavailable for any of the study visits
5. Light sensitive conditions: meningitis, iritis, blepharospasm, albinism
6. Degenerative diseases of the retina or optic nerve: diabetic retinopathy, ischemic optic neuropathy
7. Medications known to affect retinal or optic nerve function: hydroxychloroquine, chloroquine, ethambutol, amiodarone, erectile dysfunction drugs
8. Best corrected visual acuity less than 20/40 in either eye
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Primary Children's Hospital

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Bradley Katz

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bradley Katz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Moran Eye Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form: Parental Permission Form

View Document

Document Type: Informed Consent Form: Assent Form

View Document

Other Identifiers

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IRB_00065178

Identifier Type: -

Identifier Source: org_study_id

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