Thin Film Spectacle Coatings to Reduce Light Sensitivity and Headaches in Child and Adolescent Patients With Migraine
Phase: NA
Conditions: Migraine Disorders, Photophobia
Sponsor: University of Utah

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
1. Study Introduction
1. Responsible Investigator:
Bradley Katz
Email
Training
CoI Date
bradley.katz@hsc.utah.edu 4/11/2019 MCG
1/16/2020
a. Position of the Investigator:
Faculty or Non-Academic Equivalent
Student
Staff
Resident/Fellow
Other
2. Contact Persons for the Responsible Investigator:
Name
Email
Training
Deborah Harrison
deborah.harrison@hsc.utah.edu
2/10/2017 MC
Elizabeth Nuttall
Elizabeth.Nuttall@hsc.utah.edu
3/3/2017 MCG
Katie Rogers
katie.rogers@utah.edu
7/20/2017 MC
3. Guests of the Responsible Investigator:
Last Name
First Name
E-Mail
There are no items to display
4. What type of application is being submitted?
New Study Application (or Amendment/Continuing Review)
5. Title Of Study:
Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
6. Study Purposes and Objectives:
 
Objectives: The long-term goal of the project is to reduce the severity and frequency of migraines in child and
adolescent patients who are sensitive to light.  The goal of this protocol is to test an optical filter that blocks the
wavelengths of light known to trigger migraines.

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A co-PI is developing thin film coatings that will be applied to spectacle lenses. In this protocol, the investigators will
determine the efficacy these prototype filters in a cohort of migraine patients.
7. Is this a multi-site study, where more than one site needs IRB approval?
    Yes No
8. Background and Introduction:
 
Background and Introduction: Nearly all migraine sufferers report sensitivity to light during a headache and a
significant proportion of sufferers report light sensitivity between attacks. Light is also a common trigger for migraine
headaches. Preliminary evidence indicates that migraine patients may be more sensitive to a particular portion of the
visible spectrum. We hypothesize that if we could selectively block this portion of the visible spectrum, we could
reduce the frequency and severity of headaches in migraine patients. The objective of this proposal is to develop
coatings that can be applied to spectacle lenses, contact lenses, and light sources that will block the target
wavelengths. The filters will then be tested in a cohort of adult patients with migraines.  If successful, these filters
could be a novel, non-invasive adjuvant in the treatment of migraines.
Approximately 9% of men and 18% of women are afflicted with migraines. (Stovner, 2006) Over 90% of patients with
migraines report a sensitivity to light (photophobia) during headaches. (Evans, 2008) Some migraine sufferers report
that light can trigger a migraine and some have a chronic sensitivity to light. (Main, 1997) Migraineurs are especially
sensitive to non-incandescent lighting sources such as fluorescent lights, computer monitors, and gas-vapor lamps.
A study took place in 1991 to determine if tinted spectacle lenses designed to block a specific wavelengths of light
could reduce the frequency and severity of migraines.   The tint, named “FL-41”, filtered light in the blue spectrum
around the 480nm wavelength. The researchers found that the tinted spectacle lenses reduced the frequency of
migraines from 6.2 per month to 1.6 per month in a cohort of children with migraines. (Good 1992) Since that time,
we have prescribed the FL-41 tint to a number of Moran Eye Center patients. Anecdotally, more than 80% of our
patients report that the tint improves symptoms of photophobia and headache. For some patients, the improvement
can be dramatic, allowing patients disabled by headache and photophobia to return to work. As an example, one
Moran Eye Center patient recently wrote that the fluorescent lights at church and at the City Hall where she
volunteers triggered horrible migraines.  After being prescribed spectacles with the FL-41 tint, she now leaves those
locations “feeling fantastic” and looks forward to “enjoying my family instead of nursing a migraine and taking a nap.” 
Furthermore, we’ve recently demonstrated the effectiveness of FL-41 in another light sensitive condition, benign
essential blepharospasm. (Blackburn, 2009) 
Although FL-41 has been shown to be an effective treatment, this tint has drawbacks that limit its efficacy and
acceptance by patients.  For example:
·      FL-41 has a rose-colored appearance that some patients find objectionable
·      FL-41 distorts vision to a rose-colored perception
·      FL-41 can only be applied to plastic spectacle lenses and cannot be applied to glass lenses, contact lenses
or light sources
·      Quality control in the manufacture of FL-41 is poor and we have previously demonstrated that there is
considerable variation in the transmission characteristics of FL-41 purchased at various optical shops. (Katz,
2002)
·      Because FL-41 filters neighboring wavelengths in addition to the target wavelength, there’s a limit to how
much you can block without making the tint too dark for indoor use.
·      This research team will develop a light filtering technology to overcome the drawbacks of the FL-41
tint.  This filter coating is colorless, does not distort color perception, and can be used indoors or outdoors.  The
filter coating can be applied to not only plastic spectacle lenses, but also glass lenses, contact lenses, and even
light bulbs and computer monitors.  Furthermore, because the filter will block only the specific, target wavelengths
it will likely be more effective than FL-41. 
The filter coating will be different than FL-41 because it is not a color filter. Color filters are glasses or plastics that are
doped with materials that naturally absorb portions of the light spectrum and have the drawbacks listed above.   In
contrast, the filter coating developed by this research team will use “thin-film” technology. Multi-layer “thin film”
technology consists of alternating layers of transparent materials.  The anti-reflection coating commonly found in
optical shops is in fact a thin film applied to spectacles.  Multiple layers of thin films can be designed to block narrow
regions of the light spectrum.

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
2. Study Location and Sponsors
1. Add all locations applying for approval of research via the University of Utah IRB or Human Research
Protection Program (HRPP).
Click the appropriate button(s) below to add locations:
 
Site Name
Investigators Name
Covered Entity
Sub Sites
View Intermountain Primary Children's Hospital
 
Yes
 
View University of Utah
 
Yes
 
2. Will a Central IRB (CIRB) or Single IRB (SIRB) model be used for review of this study for the sites listed in
this application?
  Yes No
3. Indicate the source(s) of funding obtained or applied for to support this study.
 Sponsor
Sponsor Type
Sponsor Contact Information
Prime Sponsor
Prime Sponsor Type
There are no items to display
4. Does this study have functions assigned to a Contract Research Organization (CRO)?
  Yes No
5. Does this study involve use of the Utah Resource for Genetic and Epidemiologic Research (RGE)?
Examples: Utah Population Database (UPDB), Utah Cancer Registry (UCR), All Payers Claims Database (APCD),
etc.
  Yes No

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
Addition of a Site
1. Site Name:
Intermountain Primary Children's Hospital
2. Site Principal Investigator
Mark if Same as Responsible Investigator (syncs with investigator on
the first page) 
a. Position of the Site Principal Investigator
b. Will the Site PI consent participants?    Yes No
3. Site Contact Persons, if different from the Site PI:
Mark if Same as Contacts for Responsible Investigator (syncs with
contacts on the first page)
Name
Email
Training
There are no items to display
4. Site Staff and Sub-Investigators
Name
Email
Training
Obtaining
Consent
CoI Date
Katie
Rogers
katie.rogers@utah.edu 7/20/2017
MC

12/22/2017
5. Site Guests:
Name
Email
Training
There are no items to display
6. Select HIPAA coverage for this study:
Study procedures will be conducted within a HIPAA Covered Entity at this site
(HIPAA Privacy Rule applies)
7. Select the study procedures that will be conducted at this site:
There are no items to display
8. Select the University of Utah department responsible for this research:
9. Add any additional sites that are part of this performance group
There are no items to display

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
Addition of a Site
1. Site Name:
University of Utah
2. Site Principal Investigator
Mark if Same as Responsible Investigator (syncs with investigator on
the first page) 
a. Position of the Site Principal Investigator
b. Will the Site PI consent participants?    Yes No
3. Site Contact Persons, if different from the Site PI:
Mark if Same as Contacts for Responsible Investigator (syncs with
contacts on the first page)
Name
Email
Training
There are no items to display
4. Site Staff and Sub-Investigators
Name
Email
Training
Obtaining
Consent
CoI Date
Katie
Rogers
katie.rogers@utah.edu 7/20/2017
MC

12/22/2017
5. Site Guests:
Name
Email
Training
There are no items to display
6. Select HIPAA coverage for this study:
Study procedures will be conducted within a HIPAA Covered Entity at this site
(HIPAA Privacy Rule applies)
7. Select the study procedures that will be conducted at this site:
There are no items to display
8. Select the University of Utah department responsible for this research:
PEDIATRIC NEUROLOGY
9. Add any additional sites that are part of this performance group
There are no items to display

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
3. Participants
1. Ages of Participants:
7 to 17 years old
(Parental permission and assent form needed)
2. Specific age range of participants (e.g., 7-12 years old, 60+, etc.):
8-18 years
3. Indicate any vulnerable participant groups (other than children) included:
None
 
 If "Other", please specify: 
 
 If "None" and no children are involved, answer the following question.
Has the participant selection process overprotected potential subjects who are considered
vulnerable so that they are denied opportunities to participate in research?
  Yes No
4. Number of participants to be included and/or enrolled in this entire study, across all study locations: 50
 
At Utah prior to October 2019: 50
5. Characteristics of Participants/Inclusion Criteria:
1. Must be diagnosed with migraine with aura or migraine without aura
2. Must have at least 10 headache days per month
6. Participant 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
7. Is a substantial percentage of the participant population anticipated to be non-English
speaking?

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  Yes No

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
Vulnerable Populations
 
Justification Requirements for the Inclusion of Vulnerable Populations
1. How does the nature of the research require or justify using the proposed subject population?
Very few migraine medications are specifically approved for use in the pediatric population. Specially coated spectacles
could represent an effective, non-pharmacologic adjuvant in the treatment of migraine and light sensitivity in this
population. 
2. Would it be possible to conduct the study with other, less vulnerable subjects?
  Yes No
 
 If yes, justify the inclusion of vulnerable subjects:
3. Is this population being included primarily for the convenience of the researcher?
  Yes No
 
 If yes, explain:
4. Does the scientific merit of the study warrant the inclusion of subjects who may either be
susceptible to pressure or who are already burdened?
  Yes No

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
4. Study Information
1. Design of Study (select all that apply):
Survey/Questionnaire Research
Prospective Clinical Research
If Other, describe:
2. Does your study involve the use of any placebo?
  Yes No
3. Length of entire study, from initiation through closeout:
2 years
4. How will participants be recruited or identified for inclusion in the study?
a. Select all methods that will be used:
In-person contact (e.g., patients, students, etc.)
Written advertising (flyers, brochures, website postings, newspaper ads, etc.)
b. Describe the recruitment/participant identification process in detail (e.g. who will review charts or
records, who can refer participants to the study, where will flyers be posted, how often will recruitment
letters be sent, when will follow-up phone calls be made, etc.):
Subjects will be recruited directly from the clinics of the investigators.  Flyers will be posted in the clinics. When
potentially qualifying patients are identified, the clinic staff will contact the study coordinator to consent the
patient that day, or if the patient/parent have given permission for the study team to contact them by phone, the
clinic staff will provide patient/parent contact information to the study coordinator so she may follow up with the
family about the study.
The study will be described to the patient and their family. Patients who express an interest will be invited to
participate. 
Patients/families may consent the same day they are informed about the study, or at a later time.  They are
welcome to arrange a separate appointment to consent and enroll in the study if they wish.
No database pools or participant pools will be utilized.
5. How will consent be obtained?
Informed Consent Process (with or without a document)
6. Describe all the procedures chronologically, from screening/enrollment through study closeout, which will be
completed in the research project.
Once a subject meets eligibility criteria, informed assent will be obtained from the subject and informed consent will
be obtained from the parent or guardian. With the help of their parent/guardian, subject will complete a brief
questionnaire and the HIT-6 ("Headache Impact Test")
Subjects will be asked to try on two different test lenses - each has a mirror coating that reflects light. One blocks light
at 480 nm (a bluish color) and one that blocks light at 620 nm (an orange color). Subjects will be asked which lens
they think would help most with their headaches.

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Subjects will be asked to complete a headache diary every day for one month. During this month, no study lenses are
worn. At the end of the first month, subjects return for visit 2/4. They fill out another questionnaire, another HIT-6 and
receive study glasses. Subjects who already wear glasses will receive study glasses customized to their prescription.
Subjects who do not wear glasses will receive plain spectacles (no prescription) with the study coating. Subject will
be asked to wear the study glasses during all waking hours. They will continue to fill out daily diary entries.
At the end of the second month, subjects return for visit 3/4. Study glasses are returned, the third set of
questionnaires are completed. If the subject did not find the initial glasses to be effective, they will be asked if they'd
like to try the other coating. If yes, they undergo a 4-week washout period and are given a second set of study lenses.
If no, they continue in the study for four more weeks, as outlined below and exit the study.
For the third and final month, subjects are not wearing any study glasses. Diaries continue to be kept. At the end of
the third month, subjects return for visit 4/4. Diaries are returned and a final set of questionnaires are completed.
Only non-conflicted members of the research team or third parties will collect and analyze all data for this research. 
All data will be masked during the collection and analysis phases of the research.
7. Are all procedures for research purposes only (non-standard or non-standard of care procedures)?
  Yes No
If no, list the procedures that are performed for research purposes only (non-standard or non-standard
of care procedures):
8. Is there a safety monitoring plan for this study?
  Yes No
9. Provide a summary of the statistical methods, data analysis, or data interpretation planned for this study.
Factors for determining the proposed sample size (e.g., power) should be stated.
Primary endpoint is a 30% reduction in HIT-6 scores. Secondary endpoints are a 30% reduction in headache
frequency and severity. Questionnaires, HIT-6, and diary data will be used to evaluate these endpoints. The first and
third months of the study serve as baseline data for subjects. Data collected during these two months will be
compared to data collected during the second month, when study lenses are worn. A Student's T-test should be
sufficient for evaluating these data.

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
Consent Process
1. The following investigators and internal staff will obtain consent (as indicated on the Study Location and
Sponsors Page):
Katie Rogers
Intermountain Primary Children's Hospital
University of Utah
List by name, role, and affiliation any others who will obtain consent (e.g. Dr. John Smith, Co-Investigator, etc.).
2. Describe the location(s) where consent will be obtained.
Primary Children's Medical Center in SLC and in Riverton
3. Describe the consent process(es), including the timing of consent. Describe whether there is a waiting period
between the consent process and obtaining consent from the participant (i.e., any time between informing
participants and actually obtaining consent).
Because subjects will not undergo any intervention for one month, there will be no waiting period between the consent
process and obtaining consent. 
Informed consent for all potential research participants will be obtained by a member of the research team who does not
have any conflicts of interest related to this research or by an appropriate third party approved by the Individual Conflict
of Interest Committee.
Update for Continuing Review 2016: Authorization to obtain consent is now limited to Dr. Candee and Katie Farnsworth.
Update for Amendment Changing PI to Dr. Katz: Authorization to obtain consent is now limited to Katie Farnsworth.
4. Describe what measures will be taken to minimize the possibility of coercion or undue influence.
Study personnel obtaining consent will emphasize to potential participants that participation is strictly voluntary and that
their decision to participate, or not participate, will not affect their care.
5. Describe the provisions that are made to allow adequate time to exchange information and questions between
the investigator and participant.
Study personnel will ask potential families if they'd like more time to make a decision about participation. Study
personnel will ask potential families if they'd like to discuss the research with other family members or friends before
making a decision to participate.
6. Will a legally authorized representative (LAR) be used?
  Yes No
7. Will a language other than English be used to obtain consent?
  Yes No
8. Are you requesting that documentation of informed consent be waived by the IRB (a consent process in place,
but no documentation of consent, e.g. questionnaire cover letter, web-based consent, consent without
signature, etc.)?
  Yes No
If yes, complete the following:
a. Explain why the waiver of consent documentation is being requested.

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b. Justification for the waiver is one of the following:
There are no items to display

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
5. Data Monitoring Plan
1. Privacy Protections: Privacy refers to persons and to their interest in controlling access of others to themselves. Privacy
can be defined in terms of having control over the extent, timing and circumstances of sharing oneself (physically,
behaviorally, or intellectually) with others. What precautions will be used to ensure subject privacy is protected?
 
Select all that apply:
The research intervention is conducted in a private place
Discussing the study with participants individually instead of in front of a group
The collection of information about participants is limited to the amount necessary to achieve the aims of the research, so
that no unneeded information is being collected
Allowing for anonymous submission of surveys and questionnaires
 
 Other or additional details (specify):
2. Confidentiality Precautions: Confidentiality is an extension of the concept of privacy; it refers to the subject's
understanding of, and agreement to, the ways identifiable information will be stored and shared. Identifiable information
can be printed information, electronic information or visual information such as photographs. What precautions will be
used to maintain the confidentiality of identifiable information?
 
Select all that apply:
Storing research data on password protected computers or in locked cabinets or offices
Participant identifiers will be stored separately from the coded, participant data
All data that will be transferred or transported outside of the institution will be encrypted
 
 Other or additional details (specify):
3. Will photos, audio recordings, or video recordings, or medical images of participants be made
during the study? 
  Yes No
 
 If yes, describe the recording/images and what will become of them after creation (e.g.,
shown at scientific meetings, stored in the medical/research record, transcribed, erased,
etc.):
4. How will study data and documentation be monitored throughout the study?
 
Select all that apply:
Periodic review and confirmation of participant eligibility
Periodic review of informed consent documentation
Periodic review of the transfer/transcription of data from the original source to the research record
 
 Other additional details (specify):
5. Who will be the primary monitor of the study data and documentation?
 
Select all that apply:
Principal Investigator

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Study Coordinator or Research Nurse
 
 Other or additional details (specify):
6. How often is study data and documentation monitoring planned (e.g., monthly, twice a year,
annually, after N participants are enrolled, etc.)?
quarterly

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
6. Risks and Beneﬁts
1. Describe the reasonable foreseeable risks or discomforts to the participants:
Subjects who wear glasses may feel self-conscious about wearing glasses with a coating that looks "different" from
standard spectacles. Subjects who do not wear glasses may feel self-conscious about wearing glasses.
2. Describe the potential benefits to society AND to participants (do not include compensation):
If effective, the experimental coating could become the first FDA-approved non-pharmcologic intervention for migraine.
Very few prescription medications are approved by the FDA for use in children and adolescents. The experimental coating
could eventually benefit migraine patients both inside and outside the study. These coatings are not regarded as a "cure";
They could be a useful adjuvant in migraine treatment.
3. Are there any costs to the participants from participation in research?
  Yes No
 
 
If yes, specify:
4. Is there any compensation to the participants?
  Yes No
 
a.
If yes, answer the following:
Specify overall amount:
Up to a maximum of $80
 
b. Specify when participants will be paid (e.g. at each visit, at end of study, etc.):
There will be "prizes" at 3 time points after filling out the required surveys at those time points (end of 1 month, 2
month and 3 months). 
At the conclusion of the study participants will be given the option of keeping the study glasses or returning them to us
and us paying them $20.
 
c. If applicable, please specify payment by visit or other time interval (e.g. $10 per visit, etc.):
Each time participants complete the required surveys (end of month 1, 2, and 3) they will be able to choose form one
of the "prizes" below in the form of a gift card worth up to $20. 
Prizes:
7 Peaks Water Park
Amazon
Barnes and Noble
Baskin Robbins
Boondocks Fun Center
Clark Planitarium
Cold Stone Creamery
Dinosaur Park 
Domino's Pizza
Google Play gift card
Heber Valley Railroad
Hogle Zoo
iTunes gift card
Living Planet Aquarium

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Momentum Indoor Climbing Gym
Pappa John's Pizza
Spotify premium gift card
Thanksgiving Point: Museum of Ancient Life
Thanksgiving Point: Nat Geo Mammoth Screen Theater
The Leonardo Mueseum 
Tracy Aviary
wAIRhouse trampoline park
 
d. If applicable, explain plan for prorating payments if participant does not complete the study:
Participants will receive a gift card each time they complete a required survey. They may choose a gift card worth up
to a maximum of $20 or a $20 check at the end of the study.

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
7. HIPAA and the Covered Entity
1. Does this study involve Protected Health Information (PHI) or de-identified health
information?
  Yes No
a. Select the method(s) of authorization that will be used:
(Consent and) Authorization Document
b. Will PHI be disclosed outside the Covered Entity?
  Yes No
To whom? 
FDA
And for what purposes?
Because the spectacle lenses may be considered an investigational medical device, the FDA may require
access to PHI.
Does this study involve any of the following:
2. The investigational use of a drug?
  Yes No
3. The investigational use of a medical device?
  Yes No
4. Is this an investigator-initiated drug or device trial lead by the Principal Investigator?
  Yes No
5. Exposure to radioisotopes or ionizing radiation?
  Yes No
6. A Humanitarian Device Exemption (HDE)?
  Yes No
7. Genetic testing and/or analysis of genetic data?
  Yes No
8. Creating or sending data and/or samples to a repository to be saved for future research
uses?
  Yes No
9. Are you introducing recombinant or synthetic nucleic acids (such as viral vectors,
plasmids, or oligonucleotides, or cells containing recombinant or synthetic nucleic acids)
or human pathogens (viruses, bacteria, etc.) into human research participants or collecting

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samples (blood, tissue, cells, etc) from human participants for research purposes? 
  Yes No
10. Does this study involve any of the following?
Cancer Patients
Cancer Hypothesis
Cancer risk reduction
Cancer prevention
  Yes No
11. Any component of the Center for Clinical and Translational Science (CCTS)?
  Yes No
The Clinical Services Core (CSC)?
  Yes No

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
Investigational Use of a Device
 
1. What is the initial risk determination of the device study according to the investigator and/or
sponsor?
The study is a non-significant risk (NSR) device study.
 
a. Provide IDE (or HDE) Number(s) for significant risk devices:
IDE #
Device Name
IDE Holder
There are no items to display
 
b. Attach verification of the IDE number for significant risk devices to the Documents and
attachments page.  Please check the method by which you choose to verify the IDE number:
There are no items to display
2. Describe the plan to control, store, and dispense the investigational device. This plan should
ensure that the device is only used by qualified investigator(s) for the participants enrolled in
this research project.
Thin film coatings for spectacles are similar in design to anti-reflective coatings commonly dispensed for prescription and
cosmetic eyewear. These coatings may be purchased without a prescription from a physician. They pose no risk to
subjects. However, because they could be considered a medical "device”, all study lenses will be numbered and stored in
a locked cabinet. Only the PI, co-investigators, and study staff
under the PI's direct supervision will have access to lenses and the PI will use an Excel log to track the location of all
lenses.

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
Non-Signiﬁcant Risk Device
Review the following definition of a non-significant risk (NSR) device:
1. The medical device is not a significant risk device, because all of the following are true:
a. The medical device is NOT intended as an implant that presents a potential for serious risk to the health, safety, or
welfare of a subject.
b. The medical device is NOT purported or represented to be for a use in supporting or sustaining human life that
presents a potential for serious risk to the health, safety, or welfare of a subject.
c. The medical device is NOT for a use of substantial importance in diagnosing, curing, mitigating, or treating
disease, or otherwise preventing impairment of human health that presents a potential for serious risk to the
health, safety, or welfare of a subject.
d. The medical device is does NOT otherwise present a potential for serious risk to the health, safety, or welfare of a
subject.
2. The medical device is not banned.
1. Provide justification of why the investigational medical device used in this study meets the
definition of a NSR device.  
Thin film coatings for spectacles are similar in design to anti-reflective coatings commonly dispensed for prescription and
cosmetic eyewear. These coatings may be purchased without a prescription from a physician. As such, the coatings do
not present a potential for serious risk to the health, safety, or welfare of a subject. 
The coatings are NOT intended as an implant, NOT purported or represented to be for use in supporting or sustaining
human life, and NOT for use in the diagnosis or cure of disease. Although they are intended for the mitigation of migraine
and photophobia, they do not present a serious risk to the health safety, or welfare of subjects.
These coatings are not banned.
Eyewear is not currently regulated by the FDA. Daily wear contact lenses and contact lens cleaning solutions are
specifically cited as examples of NSR devices
(http://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126418.pdf). By extension, it seems reasonable that
the frames, lenses and coatings to be used in this study would also be considered NSR.
 

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
8. Resources and Responsibilities
1. State and justify the qualifications of the study staff: 
All sub-investigators, study coordinators and research assistants to whom study-related tasks are delegated are
qualified by education, training, and experience to perform the tasks the PI delegates to them. A qualified physician, or
a nurse practitioner specialist in neurology, (i.e., the PI or an MD or FNP sub-investigator) is responsible for all
medical-related decisions and care.
 
2. Describe the training that study staff and investigators will receive in order to be informed
about the protocol and understand their research-related duties and functions: 
Staff and investigators will hold regular meetings with the PI to discuss progress of the study, training to perform
specific study procedures delegated by the PI, and training on regulatory requirements and proper conduct of a
research study. The PI will maintain documentation of all
CITI and other study-related training received by study staff.
 
3. Describe the facilities where the research activities will be performed (e.g. hospitals, clinics,
laboratories, classrooms/schools, offices, tissue banks, etc.). 
This study will be conducted at PCMC in the clinics of the investigators. Data analyses will take place in the offices of
the investigators at PCMC, the Moran Eye Center and UUHSC. 
4. Describe the medical or psychological resources available at this site (and other
participating sites, if applicable) that participants might require as a consequence of the
research. If not applicable, please state. 
Not applicable, minimal risk study. 

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
Documents and Attachments
If any of your documents (such as investigational brochures, sponsor protocols, advertisements, etc.) are not available in an electronic format, please scan
and save them as PDF files or contact our office for assistance.
Naming Documents: Please use the title field to clearly indicate the content of each form. The name you enter will be listed on your approval letter. Use
names that will differentiate from earlier versions.
Examples:
Consent Document Control Group 04/14/05
Consent Document Treatment Group 4/14/05
Sponsor Protocol 04/14/05 Version 2
Assent Document(Highlighted Changes)
Apple/Macintosh Users:MS Word documents must have a .doc file extension. See ERICA home page for instructions.
Print View: IRB Draft Protocol Summary
eProtocol Summary:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Consent Documents, Consent Cover Letters, Consent Information Sheets, Consent Scripts, etc.:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Parental Permission Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Assent Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
VA Consent Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Surveys, Questionnaires, Interview Scripts, etc.:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Full Protocol (company protocol, sponsor protocol, investigator-initiated protocol, etc.):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Investigational Brochure (IB) for Investigational Drug or Drug/Device Package Insert:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display

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Literature Cited/References:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Principal Investigator's Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
 CV 2017 April.pdf
0.04
1/15/2016 6:10 PM
7/24/2017 7:15 AM
 
Faculty Sponsor's Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Other Stamped Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Recruitment Materials, Advertisements, etc.:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display
Other Documents:
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
Finish Instructions
 
Finish Instructions
1. To view errors, select the "Hide/Show Errors" option at the top or bottom of the page. If you have errors on
your application, you won't be able to submit it to the IRB.
2. Selecting the Finish button will NOT submit the application to the IRB.
You MUST select the "Submit" option on the workspace once you've selected the "Finish" button.
3. If your study has a faculty sponsor: Once the PI submits the application, it will be sent to the faculty sponsor
for final approval. The IRB cannot review the study until the faculty sponsor submits the application to the IRB.
 

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IRB_00065178
Created: 5/5/2013 4:38 PM  
PI: Bradley Katz M.D., Ph.D.
Submitted: 7/17/2013  
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
 
PCH Administrative Research
Questions
You have indicated Primary Children's Hospital is a study location. Please
complete the following questions so Primary Children's can confirm that
your study:
1. Aligns with Primary Children's Mission, Vision and Values
2. Receives approval from the Primary Children's resources impacted
(e.g.: lab, radiology, infant unit, etc.); and
3. Identifies Primary Children's study related charges from standard of
care charges
If you have any questions or concerns regarding this form or the associated
Primary Children's approval process, please contact:
Brenda Maldonado
Research IRB Coordinator
Pediatric Education Services
Intermountain Primary Children's Hospital
Email: brenda.maldonado@imail.org
Phone: 801-507-9248
Principal Investigator: Bradley Katz , 5-6653, bradley.katz@hsc.utah.edu
Contact Person(s):
Last Name First Name E-Mail
Phone
Harrison
Deborah
deborah.harrison@hsc.utah.edu
5-6645
Nuttall
Elizabeth
Elizabeth.Nuttall@hsc.utah.edu
801-213-3461
Rogers
Katie
katie.rogers@utah.edu
801-585-6647
IRB_00065178
Title: Thin film spectacle coatings to reduce light sensitivity and headaches 
in child and adolescent patients with migraine
Description of Study: 
 
Objectives: The long-term goal of the project is to reduce the severity and
frequency of migraines in child and adolescent patients who are sensitive to

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light.  The goal of this protocol is to test an optical filter that blocks the
wavelengths of light known to trigger migraines.
A co-PI is developing thin film coatings that will be applied to spectacle
lenses. In this protocol, the investigators will determine the efficacy these
prototype filters in a cohort of migraine patients.
Assigned IRB Coordinator: Hannah Owen
Anticipated Length of Study: 2 years
1. Describe how this study furthers excellence in the provision of
health care for children.
Very few treatments are approved for the treatment of migraine in
kids. The spectacle coating we've developed may become the first
non-pharmacologic FDA-approved treatment for pediatric migraine.
2. In simple, brief and specific terms, tell us what this study will
be doing.
We will recruit kids with migraine who are suffering more than 10
headache days per month. For the 1st and 3rd month of the study,
subjects will not wear any special glasses, but will carefully track
the frequency and severity of their headaches. During the 2nd
month, subjects will be asked to wear spectacles with a coating
that has been developed to reduce light sensitivity, migraine
frequency and migraine severity. Subjects who don't already wear
glasses will be given non-prescription spectacles. Subjects who
already where glasses will get custom-coated lenses with their
prescription. The coating is safe for wear indoors and out. We hope
to observe a statistically significant reduction in migraine frequency
and severity in our subjects. 
3. Project Funding Type:
 SponsorSponsor
Type
Sponsor Contact
Information
Prime
Sponsor
Prime
Sponsor
Type
There are no items to display
Where is the funding for the project coming from?
4. Will data be pulled from any PCH or Intermountain electronic
system(s)?
  Yes No 
5. Do you need a qualified data analyst from intermountain to
query an Intermountain or PCH database in order to produce a
limited data set for your study?
  Yes No 
6. Will individuals associated with this study need to be granted
access to PCH or Intermountain information systems?
  Yes No 
7. Will patient consent be obtained for access to the patient
information?
  Yes No 
8. Could there be any inventions developed from this research?
  Yes No 
a. If Yes, can you identify a date of the first written
description or test of each invention?
a patent application for the experimental coating has been
submitted to the USPO and EUPO. 

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b. If Yes, has there been any communication about any
of these inventions to others?
  Yes No 
If yes, identify to whom and on what date.
see above; preliminary patent application is in the public
domain and can be accessed through Google Patents 
9. Does this study involve inpatients?
  Yes No
10. Does this study involve outpatients?
  Yes No 
a. Percent Inpatient:
 
b. Percent Outpatient:
100 
c. Check all that apply:
Other (List)
If Other, please list:
neurology 
11. Will ANY of the participants be non-English speaking?
  Yes No 
12. Does this study involve any other PCH departments?
  Yes No 
13. Will the PI, study coordinator, research assistant or other
person associated with this proposal need access to PCH
facilities, systems, or equipment that they don't already have?
  Yes No 
14. Will PCH staff be required to perform any duties associated
with this study in addition to routine patient care activities?
  Yes No 
15. Are diagnostic studies required as part of this study?
  Yes No 
16. Are any diagnostic studies requested above standard of care
intended to be charged to an institutional account?
  Yes No 
17. This study is not an investigational drug study.
This study is an investigational use of a medical device study.
 
Participants PCH 1st year:
30 
Participants PCH total study:
50 
18. Cybersecurity Questions for
Intermountain

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Intermountain CyberSecurity conducts risk assessments on
research projects involving Intermountain Data. Intermountain Data
is considered to be any information that originates from an
Intermountain owned and/or managed information system. For
example: iCentra, HELP2, Intermountain's EDW, SelectHealth, etc.
The following set of questions is designed to gather study-specific
information regarding data handling and security considerations for
any component of the research project using Intermountain Data or
systems and should be answered within this context.
Chart Review
For the purposes of this study will you export, transcribe,
abstract, or otherwise copy information from an Intermountain
information system?
  Yes No
Please contact us with any questions or concerns regarding completion of this. Please note
both IRB approval and PCH administrative approval is required prior to starting the project.
Thanks again for your support as together we put the Child First and Always.
brenda.maldonado@imail.org || 801-507-9248