70 Versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in Situ Keratomileusis
Phase: NA
Conditions: Operative Incision
Sponsor: University of Utah

Study Title:  70 versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in situ Keratomileusis 
NCT Number:  NCT03122535 
Document Date: 05 July 2018 
The following Protocol and Statistical Analysis Plan were in place at the time of study closeout with the 
IRB.  IRB closeout occurred on 05 July 2018. 

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IRB_00074858
View: 1. Study Introduction
Date: Wednesday, December 23, 2020 12:14:41 PM
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in Femtosecond
Laser-assisted in situ Keratomileusis
 
1. Study Introduction
1. Responsible Investigator:
Mark Mifflin
Email
Training
CoI Date
mark.mifflin@hsc.utah.edu 6/12/2020 MCG
9/19/2020
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
2/24/2020 MCG
Elizabeth Nuttall
Elizabeth.Nuttall@hsc.utah.edu
2/4/2020 MCG
3. Guests of the Responsible Investigator:
Last Name
First Name
E-Mail
church-livingston
myrna
myrna.church@hsc.utah.edu
4. What type of application is being submitted?
New Study Application (or Amendment/Continuing Review)
5. Title Of Study:
70 versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in situ Keratomileusis
6. Study Purposes and Objectives:
Different side-cut angles have been used in Femtosecond Laser-assisted in Situ Keratomileusis (FS-LASIK), but no
study has compared the safety and efficacy of 70 and 110 degrees side-cut angles. We aim to conduct a prospective
trial comparing 70 and 110 degrees side-cut angles on same patient undergoing FS-LASIK. One angle will
be performed on the right eye and the other on the left eye. The study will evaluate uncorrected visual acuity, best
corrected visual acuity, intraoperative, and postoperative complications. By performing different side-cut angles on a
same individual will allow a direct comparison of outcomes, minimizing confounding variables. Additionally, the LASIK
flap will be performed using either the Abbott Medical Optics Intralase femtosecond laser or the Alcon Wavelight
FS200 femtosecond laser.

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7. Is this a multi-site study, where more than one site needs IRB approval?
    Yes No
8. Background and Introduction:
Laser-assisted in Situ Keratomileusis has become the preferred corneal procedure to correct certain refractive errors.
Technological advances have increase the accuracy and precision of current treatments. One of the major
advancements in LASIK has been the introduction of Femtosecond Laser technology for flap creation. Several
studies have compared microkeratome and femtosecond laser technology, showing superior accuracy and precision
of flap dimensions in the latter.
The Femtosecond Laser technology provides different parameters and settings that can be changed according to the
surgeon's preference. One of such parameters is the side-cut angle. Some of the most common side-cut angles used
today include 45, 70, 90, and 110 degrees. Previous studies have reported on the visual outcomes of side-cut angles,
but head to head comparisons are lacking.  Currently, there are no studies comparing the safety and efficacy of the
70 and 110 side-cut angles in FS-LASIK. Information regarding the outcomes and complication rates between these
side-cut angles will provide an objective measure that can be used when deciding which one is more suitable in FS-
LASIK.

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IRB_00074858
View: 2. Location and Sponsor
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in
Femtosecond Laser-assisted in situ Keratomileusis
 
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 University of Utah
Mark Mifflin
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_00074858
View: View/Edit
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in Femtosecond
Laser-assisted in situ Keratomileusis
 
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) 
Mark Mifflin
Email
Training
CoI Date
mark.mifflin@hsc.utah.edu 6/12/2020
MCG
9/19/2020
a. Position of the Site Principal Investigator
Faculty or Non-Academic Equivalent
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
Deborah Harrison
deborah.harrison@hsc.utah.edu
2/24/2020 MCG
Elizabeth Nuttall
Elizabeth.Nuttall@hsc.utah.edu
2/4/2020 MCG
4. Site Staff and Sub-Investigators
Name
Email
Training Obtaining
Consent
CoI Date
Ashley
Brundrett
ashley.brundrett@hsc.utah.edu
 

8/25/2017
Christopher
Smith
christopherb.smith@hsc.utah.edu  

7/12/2017
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:
Recruitment
Consent/Enrollment
Research observation/intervention with participants

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Data collection
Data analysis
Do you have an enrollment goal or anticipated enrollment number
for this site?
 
Yes
No
8. Select the University of Utah department responsible for this research:
OPHTHALMOLOGY
9. Add any additional sites that are part of this performance group
There are no items to display

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IRB_00074858
View: 3. Participants
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in Femtosecond
Laser-assisted in situ Keratomileusis
 
3. Participants
1. Ages of Participants: 
18 and older
(Consent form needed)
2. Specific age range of participants (e.g., 7-12 years old, 60+, etc.): 
21 years and older
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: 200
 
At Utah prior to October 2019: 200
5. Characteristics of Participants/Inclusion Criteria: 
Subjects who are deemed suitable candidates for bilateral LASIK will be considered elegible for participation in this study.
Correction will be distance for both eyes. Patients must be at least 21 years of age.
6. Participant Exclusion Criteria: 
Selection will be consistent with current standard of care. Any patient that is not a suitable candidate for LASIK will not be
included.
7. Is a substantial percentage of the participant population anticipated to be non-English
speaking? 
  Yes No

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IRB_00074858
View: 4. Study Information
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in Femtosecond
Laser-assisted in situ Keratomileusis
 
4. Study Information
1. Design of Study (select all that apply):
Non-Experimental and/or Descriptive Research Design:
There are no items to display
Experimental and/or Interventional Research Design:
Prospective Biomedical Intervention or Experiment
Randomized Trial
 Development of a research resource (repositories, databases, etc.)
 Other
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.)
Other
Information will be included on the moran eye center website, moran eye center facebook, and moran eye
center twitter account. 
http://healthcare.utah.edu/moran/patient_care/refractive_surgery_lasik/ 
https://www.facebook.com/moraneyecenter 
https://twitter.com/MoranEyeCenter
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.):
When patients come in requesting refractive surgery, they are asked if they would like to participate in the study.
An advertisement will be included on the Moran Eye Center website, facebook page, and twitter account, as
well as in newsprint.
5. How will consent be obtained?
Informed Consent Process (with or without a document)

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6. Describe all the procedures chronologically, from screening/enrollment through study closeout, which will be
completed in the research project.
Patients who are interested and eligible to participate in this study will sign the study informed consent prior to
surgery. As is standard for our LASIK cases, they will also be required to watch an informational video, read and sign
the “Consent to Have Refractive Surgery” and respond to a brief test concerning its content.
All surgical procedures will be performed according to the surgeons’ standard practices. The study outcome
measures are standard of care for pre-operative and post-operative evaluation of refractive surgery patients.
All study outcome measures will be evaluated for both eyes at every visit. Patient will be masked as to the treatment
they receive in either eye so as not to influence their sunjective responses and visual measurements.  Post-operative
evaluations will be performed at 1 day, 1 week (± 3 days), 1 month (± 10 days), 3 months (± 14 days), 6 months (± 1
month), and 12 moths (± 1 month). Interim examinations may be performed as necessary according to the surgeon’s
usual care, but are not considered part of the study data.
Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated
as per protocol. Patients have the right to withdraw at any time and future medical care will not be influenced by their
lack of participation.
Patients will be evaluated with the following procedures:
·       Manifest refraction (sphere, cylinder and axis): Pre op and post-op months 1 (± 10 days), 3 (± 14 days), 6 (± 1
month), and 12 (± 1 month).
·       Uncorrected corrected visual acuity: Pre-op and post-op day 1, week 1, and months 1 (± 10 days), 3 (± 14
days), 6 (± 1 month), and 12 (± 1 month) using the Snellen Eye chart
·       Best corrected visual acuity: Pre-op and post-op months 3 (± 14 days), 6 (± 1 month), and 12 (± 1 month).
·       Pupil size measured in the dark: Pre-op only
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):
Data collection and analysis are for research purposes only.
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.
Summary statistics will be calculated and used to describe the treatment groups (70 versus 110 degrees side-cut
angles) in terms of all study variables: manifest refraction, corrected and uncorrected visual acuity and LASIK system
used (FS200 or intralase). Statistics will be compiled for the one week, one month, three month, six month and 12
month time points post operatively.  Paired t-tests will be used to analyze the difference of corrected and uncorrected
visual acuity obtained by each group at the post-op time points, as well as the average change from pre-op to post op
corrrected and corrected visual acuities. In order to provide a statitistically significant beta values, a N number of 200
patients will be needed.

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IRB_00074858
View: 4.2 Consent Process
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in Femtosecond
Laser-assisted in situ Keratomileusis
 
Consent Process
1. The following investigators and internal staff will obtain consent (as indicated on the Study Location and
Sponsors Page):
Ashley Brundrett
University of Utah
Mark Mifflin
(PI) University of Utah
Christopher Smith
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.
Moran Eye Center Clinics
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).
Consent will be obtained following standard of care evaluations that determine if an individual is a candidate for bilateral
LASIK surgery. This occurs during a series of pre-operative clinic visits. Signed consent will be obtained prior to surgery.
4. Describe what measures will be taken to minimize the possibility of coercion or undue influence.
Patients are free to have LASIK or other refractive surgery that is appropriate for them with the investigators without
participating in the study.
5. Describe the provisions that are made to allow adequate time to exchange information and questions between
the investigator and participant.
Several pre-op exams are performed prior to surgery so the patient has multiple opportunities to ask questions and
discuss with the surgeons.
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.
b. Justification for the waiver is one of the following:
There are no items to display

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IRB_00074858
View: 5. Data Monitoring Plan
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in
Femtosecond Laser-assisted in situ Keratomileusis
 
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
Other or additional details (specify):
 
 Other or additional details (specify): 
Surgery and all study procedures will be performed in private exam areas in the Moran clinics and laser surgery.
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
Other or additional details (specify):
 
 
Other or additional details (specify): 
Patient information will be maintained in the confidential medical records in accordance with all applicable regulations.
Study specific data will be stored on password protected computers and/or locked cabinets or offices.
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
 
 Other additional details (specify): 
5. Who will be the primary monitor of the study data and documentation?
 
Select all that apply: 
Principal Investigator
Other or additional details (specify):

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 Other or additional details (specify): 
sub-investigators
6. How often is study data and documentation monitoring planned (e.g., monthly, twice a year,
annually, after N participants are enrolled, etc.)? 
Annually.

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IRB_00074858
View: 6. Risks and Benefits
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in Femtosecond
Laser-assisted in situ Keratomileusis
 
6. Risks and Beneﬁts
1. Describe the reasonable foreseeable risks or discomforts to the participants: 
Risks to study participants are the same as though for any patient undergoing LASIK refractive surgery, including loss of
vision, visual side effects, and over- or under-correction.
2. Describe the potential benefits to society AND to participants (do not include compensation): 
Evaluation of vision and complications on an individual patient who has undergone 70 degrees side-angle cut in one eye
and 110 degrees side-angle cut in the other will afford a greater understanding of the safety and efficacy of using this two
common side-cut angulations.  There is no direct benefit to participants.
3. Are there any costs to the participants from participation in research? 
  Yes No 
 
 
If yes, specify: 
Subjects will be charged the research-discounted price for LASIK ($1200 per eye).
4. Is there any compensation to the participants? 
  Yes No 
 
a.
If yes, answer the following: 
Specify overall amount: 
 
b. Specify when participants will be paid (e.g. at each visit, at end of study, etc.): 
 
c. If applicable, please specify payment by visit or other time interval (e.g. $10 per visit, etc.): 
 
d. If applicable, explain plan for prorating payments if participant does not complete the study: 

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IRB_00074858
View: 7. HIPAA
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in Femtosecond Laser-
assisted in situ Keratomileusis
 
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
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:
Collecting samples of blood, organs or tissues from participants for research purposes;  
Introducing Recombinant or Synthetic Nucleic Acids (e.g. viral vectors, oligonucleotides) or cells
containing recombinant nucleic acids (e.g. CAR-T) into participants; OR  
Introducing other biological materials (e.g. bacteria, viruses) into participants.  

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  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_00074858
View: 8. Resources & Responsibilites
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in
Femtosecond Laser-assisted in situ Keratomileusis
 
8. Resources and Responsibilities
1. * State and justify the qualifications of the study staff: 
Dr Mark Mifflin specializes in the medical and surgical treatment of corneal and anterior segment eye diseases. His expertise includes all types of corneal
transplantation, cataract surgery, and vision correction using lasers, intra-ocular lenses, and conductive keratoplasty.
Sub-investigators are ophthalmology fellows (M.D.s) and will work under the supervision of Dr. Mifflin.
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: 
The investigators have completes the CITI human subjects training. The PI has trained the sub-investigators on the
protocol.
3. * Describe the facilities where the research activities will be performed (e.g. hospitals,
clinics, laboratories, classrooms/schools, offices, tissue banks, etc.). 
Physical resources required to implement the study protocol are available at the Moran Eye Center clinics. Clinical
care services at the John A. Moran Eye Center include three fully equipped operating rooms, minor procedure rooms,
25 examination rooms, minor procedure rooms, laser suites, an optical shop, and a pharmacy.
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. 
The investigators will be available to answer any questions or discuss any concerns the participants have, both during
study visits, and over the phone. Dr. Mifflin has the expertise and medical resources to handle any medical
consequences of the research study appropriately.

12/23/2020
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IRB_00074858
View: 9. Documents and Attachments
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in
Femtosecond Laser-assisted in situ Keratomileusis
 
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
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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
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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
Mifflin CV 04.09.2014.pdf(0.01)
0.01
7/14/2015 3:23 PM
7/14/2015 3:23 PM
 
MifflinCV11-04-2016.doc(0.01)
0.01
2/21/2017 7:55 PM
2/21/2017 7:55 PM
 
Faculty Sponsor's Scholarly Record (CV/Resume):
Name
Version
Date Created
Date Modified
Date Approved
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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

12/23/2020
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IRB_00074858
View: 10.4. uTRAC Application - GN3 - Popup
IRB_00074858
Created: 6/23/2014 8:21
PM
 
PI: Mark
Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut
Angles in Femtosecond Laser-assisted in
situ Keratomileusis
 
uTRAC
University TRAcking of Clinical research (uTRAC)
All prospective clinical research studies conducted at the University of Utah must complete a uTRAC application prior to IRB
approval and the initiation of research procedures.  Based on the responses provided in your IRB application, a uTRAC
application is necessary for this study. 
For more information about uTRAC and the requirements, please contact the Clinical Research Compliance and Education
(CRCE) Office at: 
Phone: 801-213-3601 
Email: utrac-support@umail.utah.edu 
Website: https://pulse.utah.edu/site/comser/clreco
If you do not have a uTRAC account, please have your department’s account requestor request one. If you are unable to
locate an account requestor please contact uTRAC support utrac-support@umail.utah.edu.
Instructions:
1. If you have already created a uTRAC application, click the Select button below to link the trial to the ERICA
application.
2. If your study has been given an exemption from the CRCE office, please attach it where indicated below. 
Clinical Trials: 
Link
PI
Title
FP00005465 Mifflin 70 versus 110 Degrees Side-cut Angles in Femtosecond Laser-assisted in situ Keratomileusis
CRCE Exemption Attachments: 
Name
Version
Date Created
Date Modified
Date Approved
There are no items to display

12/23/2020
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IRB_00074858
View: 12. Finish Instructions
IRB_00074858
Created: 6/23/2014 8:21 PM  
PI: Mark Mifflin M.D.
Submitted: 7/28/2014  
Title: 70 versus 110 Degrees Side-cut Angles in Femtosecond
Laser-assisted in situ Keratomileusis
 
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.