Ocular Adaptation and Visual Performance for Accommodative Contact Lens
Phase: NA
Conditions: Functionality of Experimental Contact Lens
Sponsor: Pacific University

Institutional Review Board 
FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Office of Scholarship & Sponsored Projects - 
Proposal to Conduct Research
2 
Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Office of Scholarship & Sponsored Projects - 
Proposal to Conduct Research
2 
Office of Scholarship & Sponsored Projects 
2043 College Way | UC Box A-133 | Forest Grove, OR 97116 
(P) 503.352.1478 | (F) 503.352.1447 | (E) irb@pacificu.edu   
(W) www.pacificu.edu/about-us/offices/research-office
Proposal to Conduct Research
Research Review Boards
Institutional Review Board (IRB)
■
Study Title
Ocular Adaptation and Visual Performance for Accommodative Contact Lens
IRB Proposal and Review Type
If you are not sure if your research is considered human subjects research, please use the Request for Determination of IRB 
Jurisdiction checklist available on the IRB website (www.pacificu.edu/irb) before continuing with this form. If needed, submit 
the Request for Determination of IRB Jurisdiction to the IRB at irb@pacificu.edu. 
Request for Exemption
Proposal to Conduct Human Subjects Research
■
Expedited Review
■
Full Board Review
Research Personnel and Contact Information
Personnel #1
Name
Shun-Nan Yang
Role
Principal Investigator
Institution
Pacific University
Program
College of Optometry
Email
shunnan.yang@pacificu.edu 
Telephone
503-352-2852
Scope
Recruitment
Consent Process
Data Collection
Data Analysis (with personally identifiable information)
■
Data Analysis (de-identified data)
■
Other:

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Office of Scholarship & Sponsored Projects - 
Proposal to Conduct Research
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Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Office of Scholarship & Sponsored Projects - 
Proposal to Conduct Research
3 
Personnel #2
Name
Suan A. Resnick
Role
Co-Investigator
Institution
Farkas, Kassalow, Resnick and Associates, P.C.
Program
Email
sresnick525@gmail.com
Telephone
212-355-5145
Scope
Recruitment
■
Consent Process
■
Data Collection
■
Data Analysis (with personally identifiable information)
Data Analysis (de-identified data)
Other:
Personnel #3
Name
Partick Caroline
Role
Co-Investigator
Institution
Pacific University
Program
College of Optometry
Email
patpacific@aol.com
Telephone
503-352-2768
Scope
Recruitment
■
Consent Process
■
Data Collection
■
Data Analysis (with personally identifiable information)
■
Data Analysis (de-identified data)
■
Other:
Personnel #4
Name
David Geffen
Role
Co-Investigator
Institution
Gordon-Weiss-Schanzlin Vision Institute
Program
Email
dig2020@aol.com
Telephone
858-455-9950
Scope
Recruitment
■
Consent Process
■
Data Collection
■
Data Analysis (with personally identifiable information)
Data Analysis (de-identified data)
Other:
Personnel #5
Name
Timothy R. Poling
Role
Co-Investigator
Institution
Botetourt Eyecare
Program
Email
tpoling2@hotmail.com
Telephone
540-797-2780
Scope
Recruitment
■
Consent Process
■
Data Collection
■
Data Analysis (with personally identifiable information)
Data Analysis (de-identified data)
Other:

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Office of Scholarship & Sponsored Projects - 
Proposal to Conduct Research
4 
Funding and Sponsorship
Funding: 
Funding for this study is: 
Internal (Pacific University)
External
■
This study is not funded
Other:
Be sure to maintain sponsorship records as related to this study. Should this proposal be selected for an internal or external 
audit, all grant and funding documents will need to be available for review during the audit.
Identify the funding source: (*Only as applicable)
Funding Source #1
Name of Funding Source
One Focus Vision
Address of Funding Source
8358 Sanctuary Lane Fernandina Beach, FL 32034 
Funding Agency Award Number*
N/A
Award Amount
 $30,000.00 
Grant Title*
Ocular Adaptation and Visual Performance for Accommodativ
PI Listed on the Grant*
Shun-nan Yang
Deadline for Application Letter (as applicable)*
N/A
Start Date of Project*
Dec. 13, 2018
End Date of Project*
Dec. 13, 2019
Sponsor: 
If this is a clinical investigation, list and describe who is sponsoring this study. Please provide addresses for all sponsors. If the 
sponsor and funding source are the same, please state as such. If you are conducting a clinical investigation, you are required to 
list and describe who is sponsoring this study.  (If the study is not sponsored, then state Not Applicable.)
Same as the funding source.
Conflict of Interest: 
Describe any potential or apparent conflict(s) of interest that may exist. (If the study is neither funded nor sponsored, then state 
Not Applicable.) 
The investigators do not benefit from the outcomes of the proposed study, except the funding provided by the Sponsor to the Pacific 
University and eye clinics associated with this study.   
Describe any other potential conflict(s) of interest that may exist.
None.
Payment of Research Participants
Will you be paying your research participants?
YES
■
NO
N/A
Please refer to the Office of Research's website for current practices regarding payment of research participants. You may be 
required to submit additional documentation to the IRB depending on the source of funding.”

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
IRB Submission Guidance Document
5 
Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
IRB Submission Guidance Document
5 
Institutional Review Board 
2043 College Way | UC Box A-133 | Forest Grove, OR 97116 
(P) 503.352.1478 | (F) 503.352.1447 | (E) irb@pacificu.edu   
(W) www.pacificu.edu/about-us/offices/institutional-review-board
IRB Submission Guidance Document
Study Title
Ocular Adaptation and Visual Performance for Accommodative Contact Lens
Medical Device | Drug Study | Clinical Investigation
Medical Device Information
1. Are you using a medical device in your study that is not the subject of study? The device must be used in 
accordance with its approved indications, with no modifications (on-label use).
YES
NO
■
2. Are you studying a medical device in your proposal? If the medical device is the object of study, is not 
being used in accordance with its approved indications, or has not been cleared for marketing, please select 
YES. (If other medical devices are also being used in the study, please select both options, but provide only 
the information regarding the medical devices being studied on the Medical Device Study form.
YES
■
NO
You are conducting a Medical Device Study. Additional information will be required by the IRB. Please provide all 
required information on the Medical Device Study form. Additionally, please provide labels, informational brochures or 
documents, and other information pertinent to the device(s) that will (a) aide the IRB in review of your proposal and/or (b) be 
made available to participants to reference. Upload these documents as a separate resource on IRBNet. 
Drug Study Information
Are you conducting a drug study?
YES
NO
■
Biologic Information
Are you studying a biologic or other food product for human consumption?
YES
NO
■
Biologic
Other food product for human consumption
Clinical Investigation
Is this project considered a clinical investigation?
YES
■
NO
Clinical Investigation Number
NCT02923232
Consent Forms
I will be collecting signed Informed Consent.
■
Complete the Informed Consent

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
IRB Submission Guidance Document
6 
Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
IRB Submission Guidance Document
6 
I will be submitting a Request to Alter or Waive Informed Consent.
Check all that apply:
The documentation of signed informed consent will be waived.
Alteration of informed consent documentation (modified consent documents, online or
anonymous surveys, for instance).
Request to waive Informed Consent.
Vulnerable and Non-Autonomous Populations
1. Will you be collecting data from (1) children/minors, people who (2) cannot provide their own consent or (3) have a disability 
or impairment?)
YES
NO
■
2. Will you be collecting data from pregnant women?
YES
NO
■
For non-autonomous individuals, researchers must first obtain permission from the parent or guardian, then informed assent 
from the potential participant. Please refer to Informed Consent information on the IRB website for additional information 
regarding the Consent Process, particularly as it applies to Permission and Assent. Based on the answers to these questions, the 
appropriate forms have been added to the proposal.
Prisoners
Does your research involve prisoners?
YES
NO
■
HIPAA and FERPA
HIPAA
Will your research be using data covered by the HIPAA Privacy Rule?
YES
NO
■
N/A
FERPA
Will your research be using student education record data protected by FERPA? 
YES
NO
■
N/A
Release Documentation
Participant Contact Information
Will you be collecting participant's contact information?
YES
NO
■
Recording Release
Will your research include an Audio Recording? 
YES
NO
■
Photograph and Video Recording Release
Will your research use photographs or video to collect data?
YES
NO
■
International Research and Translations

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
IRB Submission Guidance Document
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Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
IRB Submission Guidance Document
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International Research
Will you be conducting research internationally?
YES
NO
■
Translation
Will any verbal or written communication with participants be conducted in a language other than English? 
YES
NO
■
Recruitment and Data Collection
Recruitment
Will you be recruiting participants for your research?
YES
■
NO
1) Please place all recruitment materials in one document, as possible, and upload separately on IRBNet. 
2) List all recruitment materials that will be attached. Recruitment materials include but are not limited to emails, phone 
scripts, announcement scripts, posters, handouts, and flyers. You may also include text of emails, verbal scripts, etc. in the 
recruiting section of the proposal if more appropriate. Please do still indicate recruitment elements below, regardless of 
submission format. 
Phone-Call Script
Announcement Script
Email text
Poster
Handout
Flyer
■
Other (if other, please list all other forms of recruitment below)
Data Collection
1) Place all data collection materials in one document, when appropriate, and upload separately on IRBNet. PDFs of online 
surveys may be uploaded in a second document, as needed. 
2) List all Data Collection materials. Data Collection materials include but are not limited to surveys, handouts, demographic 
forms, assessment tools, and interview questions. 
Assessment Tools
■
Demographic Forms
Interview Questions
Handouts
Online Survey:
Please provide the survey's URL:
Please also provide a PDF of the survey as a separate upload.
Surveys (paper) - Please upload as a separate document.
Other (if other, please list all other forms of data collection below)

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
IRB Submission Guidance Document
8 

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Proposal to Conduct Human Subjects Research
9 
Institutional Review Board 
2043 College Way | UC Box A-133 | Forest Grove, OR 97116 
(P) 503.352.1478 | (F) 503.352.1447 | (E) irb@pacificu.edu   
(W) www.pacificu.edu/about-us/offices/institutional-review-board
Proposal to Conduct Human Subjects Research
Study Title
Ocular Adaptation and Visual Performance for Accommodative Contact Lens
Research Personnel
Investigator(s)
Shun-Nan Yang, Susan Resnick, Patrick Caroline, David Geffen and Timothy Poling
Faculty Investigator (required for student investigator research)
Clinical Investigation
Clinical Investigation
YES
■
NO
Please provide all Clinical Investigation Information on the IRB Proposal Guidance Document.
Purpose
Provide enough relevant information to allow the IRB reviewers to understand the rationale and/or justification for the study and its merits 
(basic and/or applied), including any relevant study hypotheses and dissemination plans.
Presbyopia is an ocular condition resulting from the reduced flexibility and consequent loss of accommodation, an ability to change the 
optical power of the human crystalline lens.  It results in a limited range of focal distances for forming a clear retinal image.  The typical 
clinical solution to presbyopia is the fitting of single-vision or multifocal spectacle lenses.  Alternatively, single- and multi-focal contact lens 
can be fitted for presbyopes who can adapt to contact lens wearing.  Multi-focal lenses provide the convenience of changing focal distances 
with a single lens; however, unwanted aberrations due to transition between optical zones for different focal distances can be a significant 
compromise with these solutions. 
 
OneFocus Vision, Inc. (OFV) has previously bench-tested a proprietary design of accommodative contact lens (ACL), and would like to 
contract the Vision Performance Institute for a non-dispensing (within-laboratory wearing only) clinical test.  This novel design of ACL is 
based on the interaction between the force exerted by the lower eyelid and the fluid (saline or contact lens solution) inside a cavity within 
the contact lens.  The cavity exists within the lens between two layers of hydrogel, and does not get in touch with the corneal surface.  The 
water-absorbing/peameating hydrogel also allows the cavity to be filled with fluid.  When the lens is stored in saline or in lens care solution, 
the cavity will be fillled with saline or lens care solution respectively. When it is taken out of the storage box and worn over the eye during 
the testing, the saline or lens care solution should mostly remain in the cavity, and some (if any) tears might be absorbed into the cavity.  
OFV bench tests have shown that when micro-pressure (from the lower lid) is applied to the surface above the reservoir(s) containing the 
fluid, the fluid is pushed through channel(s) and enters a large reservoir extending throughout the optical zone that covers the pupil. Such 
action in turn changes the optical power of the contact lens that covers the pupil of the eye.   
 
OFV would like the Vision Performance Institute (VPI) at Pacific University and the additional sites (hereafter referred to as Salen, San 
Diego and New York sites or collectively as the "Co-investigational sites") to conduct testing to confirm the functionality of the test lens on 
voluntary participants, and to measure the visual performance afforded by the test lens.  The three sites will hold their own contract with 
OFV, but that all data will be processed and published through the VPI. 

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Proposal to Conduct Human Subjects Research
10 
 
In the proposed non-significant risk study we plan to recruit presbyopes (people who might have a significant  loss of their ability to 
accommodate their crystalline lens in the eye) to wear a test lens and perform typical clinical tests of visual acuity with different luminance 
levels and viewing distances/angles. FDA approved commercial ophthalmic equipment will be used at these sites to take images of the test 
lens on the cornea. These are similar to the typical examinations conducted for regular contact lens wearers.  Results of this testing will be 
used to evaluate the efficacy of test lenses and to provide additional information for revision of test lenses.  If shown to provide adequate 
eye comfort and intended vision correction, this lens design has the potential of allowing tens of millions of presbyopes to utilize contact 
lenses to improve their functional, everyday vision.  
 
Recruitment
1. Describe the Sample Size and relevant demographics.
Sixty four participants will be enrolled into the study.  Up to 110 potential participants will be recruited at the four sites and screened to 
obtain the needed sample size of 64.  Participants should be between 40 and 75 years of age. The number of 64 subjects will allow for 
detection of a .5 Standard Deviation difference in response time and accuracy with 80% statistical power.  This number of participant is 
usually required for a stage 2 clinical study for validating the efficacy of device design.   They will be recruited through flyers posted online 
(websites) and on bulletin boards around the community surrounding the Forest Grove Campus of Pacific University and other associated 
eye clinics (see included Flyers).  
2. Describe and justify the inclusion of any non-autonomous subjects.
N/A
■
3. Eligibility Criteria? 
List and describe the key characteristics necessary for participants in the study.
• Be between 40 and 75 years of age. 
• Have normal/corrected-to-normal monocular acuity of better than 20/25 for both eyes. 
• Have a photopic (with light stimulation) pupil diameter ≥ 2.5 mm. 
• Willing and able to wear multifocal contact lenses in both eyes. 
• Have a current optical prescription (obtained less than 2 years ago).  
• Have spherical equivalent correction equal to or higher than -1.00 Diopter and equal to or less than +0.50 Diopter. 
• Have cylindrical correction equal to less than 0.50 Diopter. 
4. Exclusionary Criteria 
List and describe the criteria that would exclude subject participation in the study (e.g., pregnancy, specific medical condition, English 
language fluency, age, etc.).
• Have no prismatic correction. 
• Without any eye infection, inflammation, disease, or abnormality that contraindicates contact lens wear within the past 6 months. 
• No clinically significant ocular pathology (e.g., cataract, keratoconus, dry eye, diabetic retinopathy, or age-related macular degeneration) 
• Have no photosensitive disorders, including migraine and seizure.  
• Have no binocular dysfunction, including amblyopia, strabismus, and other binocular diseases. 
5. Recruitment Plan
Participants will be recruited from the general population using separate recruiting flyers for the four sites (see Recruiting Flyers).  The 
flyers will be posted on the bulletin boards at affiliated eye clinics and other public places, including community centers, local restaurants, 
and coffee shops.  Research personnel will request to post flyers from the appropriate individuals at each location.  Participants will call one 
of the four sites nearest to them, as noted on the flyer, to express their interest in the study and inquire about study criteria.  An 
optometrist (Drs. Patrick Caroline at VPI, Timothy Poling in Salem, David Geffen in San Diego, or Susan Resnick in New York) will speak 

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Proposal to Conduct Human Subjects Research
11 
with the potential participants on the phone to explain the study criteria and to determine if they meet the criteria included on the 
recruitment flyer. Candidates satisfying the screening criteria will be invited to the first vision exam session and the exam will be scheduled. 
 
At the beginning of the vision exam session, the subject’s consent to the study will be obtained first by the optometrist.  S/he will then be 
examined by the optometrist based on the inclusion and exclusion criteria and tested with their habitually-worn spectacle lenses or contact 
lenses, if any.  Those satisfying the criteria will then be formally entered into the second phase of study. 
Study Methodology
1. Location of the Study
Four sites will be involved in the study:  
 
1. VPI: The study will be conducted in Room 234 of Jefferson Hall at the Forest Grove campus.  Dr. Caroline will conduct the vision 
screening and lens testing.    
2. Salem clinic: Testing will be conducted at 511 Roanoke Blvd Suite 1, Salem, VA 24153. Dr. Poling will conduct the vision screening and 
lens testing.  
3. San Diego clinic: Testing will be conducted at 8910 University Center Lane Suite 800, San Diego, CA 92122.  Dr. Geffen will conduct 
vision screening and lens testing.  
4. New York clinic: Testing will be conducted at 30 East 60th Street, New York, NY 10022. Dr. Resnick will conduct the vision screening 
and lens testing. 
2. Study Materials, Measures, and/or Apparatus to be Applied
• Test lens: Contact lenses manufactured with standard soft contact lens material, hydrogel, will be tested (see Technical Description of 
Test Lens).  Based on the FDA procedure for classifying medical devices, the test lens should have an expected rating as a Class II, 510K 
device: proposed identifier 886.5925; product code, LPL (see FDA Device Regulation Guidance at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm).  The test lens’ biological compatibility also meets the FDA testing 
guidance, as demonstrated by the provided ocular irritation and toxicity reports for soft contact lens (see Ocular Irritation and Toxicity 
Reports)  
• Video image of test lens: Infra-red video camera will be used to record the position of test lens in relation to the edge of pupil and lower 
eyelid. 
• Corneal and test lens profile Image: Ocular coherence topography (OCT) will be taken with Zeiss Cirrus OCT (VPI) or similar anterior 
segment OCT (Co-investigational sites).  Corneal and lens topography will be taken with the Medmont Topography System (VPI) or 
similar corneal topographer (Co-investigational sites)  The OCT and topographer data will be used to visualize the position and shape of 
the test lens relative to the corneal surface. 
• Measure of lens refraction power:  Shin Nippon SRW-5500 Open Field Autorefractor (VPI) or other clinical autorefractor (Co-
investigational sites) will be used to measure the refractive power and pupil size at different distances and downward angles with and 
without the test lens. 
• Visual acuity testing: An M&S visual acuity testing system (VPI) or similar computerized visual acuity testing system (Co-investigational 
sites) will be used to display high (95%) and low-contrast (10%) Snellen letters at distance (6 meters), intermediate (75 cm) and near (40 cm) 
testing distances. 
 
3. Procedures
• Telephone Interview 
 
Each participant will first talk to the optometrist who will determine whether they meet the recruiting criteria. If they meet the criteria, an 
appointment for the vision exam session will be scheduled.   
 
• Visions Exam Session 
 

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Proposal to Conduct Human Subjects Research
12 
During the vision exam session, they will first read, question and sign the consent form. They are now formally enrolled in the study and 
will then be examined by an optometrist (Drs. Caroline, Poling, Geffen or Resnick).  Distant monocular acuity, distance phoria, and 
accommodative amplitude will be measured.  Additional refractive examinations will be conducted to ensure his/her eligibility.  The 
participant will also be screened for any ocular diseases listed in the exclusion criteria.  This will take about 45 to 60 minutes.  Participants 
meeting the screening criteria will be invited back for the lens testing session.  The second testing session can be scheduled immediately 
after the vision exam session or on a subsequent date, if it is more convenient for the patient.  In the event that the participant chooses to 
return on a subsequent date, the optometrist will verbally re-consent the participant before the session begins. 
 
• Testing 
 
The formal testing session will last about 2 hours.  At the beginning of the session, corneal topography will be taken without the test lens.  
The participant will then put on the test lens and corneal topography and corneal ocular coherence topography (OCT) will be taken while 
s/he views with 0, 15, and 25 degrees of downward angle.  The viewing angle is enforced with a forehead/chin rest.   
 
In the second task, participants will be asked to view an eye chart with the 3 downward angles (0, 15, and 25 degrees) and 6m, 75cm, and 
40cm distances while their optical refraction is measured with a power refractor.  The measured results are then compared to the 
accommodative demand at these 3 distances.   
 
In the third task, eye charts will be presented at the 3 distances and corresponding angles (6 m for 0 degree, 75 cm for 15 degree, 40 cm for 
25 degree) 
 
In the fourth task, video images of the ocular surface will be taken while the eye shifts between 0 to 15 and 25 degrees downward angles 
and during eye blinks.  An infra-red video camera will be mounted on a post in front of the measured eye to acquire the eye images at 15 
Hz.  These are done for both eyes. 
 
At the completion of the fourth task, the test lens will be removed from participant’s eyes.  A slit lamp exam will be conducted to at the 
beginning and end of contact lens wearing to ensure there is no damage to the cornea.  The test lens will also be inspected to confirm its 
integrity.  An exit survey will then be conducted and documented to ensure there is no unexpected effect or symptoms except those 
typically observed with the wearing of soft contact lens (see List of Information Shared with the Sponsor). All data will be aggregated at 
VPI and then shared with the sponsor based on the above list of shared information.  
4. Timeline for Recruitment, Data Collection, Analysis, and Dissemination
Recruiting will begin once IRB approval has been obtained. Data collection will begin immediately after IRB approval and continue until 
December 31, 2018.  Data analysis will be completed before September 30, 2019.  Findings will be submitted for publication at an 
optometric conference once data analysis is completed. 
 
After the completion of data collection, a summary of test results and samples of photos and video images will be provided to the sponsor 
(see List of Information Shared with the Sponsor). Data collected from the three other sites will be sent to Pacific University who will then 
share them with the sponsor.  The summary report will not include any individual data.  All individual images and video/photos will be 
prepared in a way so that they cannot be used to identify the participant from whom they are taken.  
Risks
1. Specifically identify and briefly describe the various risks to which participants may be exposed.
Regarding study risk determination, this study is proposed as a non-significant risk study.  Safety testing in accordance with FDA testing 
requirements for a daily wear contact lens indicates the hydrogel material has been deemed as safe for use in human subjects when the lens 
is to be exposed to patients for daily use.  The study is intended as a non-dispensing, feasibility study to evaluate the design of the 
accommodating contact lens and poses minimal risk to subjects under the conditions of the study. 
 
Possible risks during testing include a minimal level of eye symptoms similar to what the participant would experience in wearing contact 
lenses.  The symptoms include dry eye and general discomfort but will be short term in nature – probably not extending beyond the testing 

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Proposal to Conduct Human Subjects Research
13 
session.  There is minimal risk in exposing the participant to 2 hours of testing.
2. Describe the likelihood of these risks occurring, how they can and will be minimized, and how they will be handled 
should they occur.
Viewing discomfort can occur due to dry eye and wearing discomfort.  Breaks will be scheduled after each of the four tasks to keep these 
symptoms at a minimal level.  If the discomfort reaches a level that interferes with task performance (as reported by the participant), the 
task will be paused and the test lens taken out.  This should allow the symptoms to dissipate.  The participant can terminate their 
participation or is allowed to resume the task only after the symptoms dissipate to a level that is acceptable to the participant and does not 
interfere with further participation. 
  
Slit lamp examination will be conducted to confirm the health of the eyes after contact lens wear. 
3. Describe any element(s) of deception of meaningful withholding of information associated with the study 
methodology.
There will be no deception or information withholding involved in the study.
4. Describe any treatment alternatives that may be advantageous to subjects, if clinical investigations are involved.
Alternative treatments available to participants include wearing bi-focal or multi-focal spectacle glasses or contact lenses, or not 
participating in the study. 
Adverse Events
How will adverse events be handled and reported?
Development of any unusual or acute eye discomfort should be relieved immediately by pausing the experiment and taking out the test 
lens.  Although none are expected, any unusually severe and long lasting eye discomfort, that cannot be mitigated by pausing the testing, 
will be noted and reported to the Institutional Review Board on the next business day.  Appropriate modification of the testing procedure 
will be made to reduce such issues and submitted to the IRB before testing of the lenses continues.
Benefit or Compensation
1. Describe the specific unique benefits subjects will realize via their participation in this study, if any.
We expect no direct benefit to the participants.  
2. Describe the payment or other reward participants will receive, if any.
All consented participants will be compensated $50 for the 1-hour vision exam session, and additional $100 for the 2 hours of lens testing 
session.  They will receive $50 if they participate in the vision exam session, but are not invited back for the lens testing session.  They will 
need to provide their Social Security number to receive the payment.  If they are a Pacific University employee, their payment will be 
reported to Payroll (depending on the value of the award/prize, it may be taxable).   
 
For those participating at the VPI site, they will be required to complete the Research Participant Payment Form prior to receiving payment 
for participation.  Additional Pacific University policies regarding payment are included on that form. This form is provided for at the end 
of the consent documentation as a reference for participants.  For those participating at the Salem, San Diego and New York sites, the 
same form and policy documents will also be provided. 
Privacy

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Proposal to Conduct Human Subjects Research
14 
How will you protect the privacy of your participants?
All recorded images, examination records, and behavioral performance results will be numerically coded and kept in a file cabinet within a 
room that is always locked when the research personnel is not in it. Only the PI will have access to the file cabinet.  Consent forms will be 
kept separately from study data.  All documents collected from the Salem, San Diego and New York sites will be sent to the VPI and stored 
separated from study data. 
 
Summary report with group data and de-identified images and videos will be provided to the sponsor for the evaluation of test lens.   
 
Confidentiality will be further preserved by coding individual results with numbers and only mean or group data will be presented in the 
publication of the results.  Any images from the study will be rendered in a way so that the participant cannot be identified.  Through use 
of code numbers, the subjects’ identities will be shielded from subsequent testing and data report.  Study data and consent forms will be 
maintained securely for three years after the completion of the study or the date of publication on a journal.  After the deadline, the date 
and document will be destroyed. 
Informed Consent
1. How will informed consent be obtained and documented? 
Describe the consent process for your study.
After the participant is determined to meet the recruiting criteria based on the phone interview, s/he will be invited to participate in the 
vision exam session.  At the beginning of the vision exam session, a brief description of the vision exam procedure and an explanation of 
the experimental setup for the lens testing session will be given to the participant by an optometrist (Drs. Zheng, Poling, Geffen or 
Resnick) using terms appropriate for them to understand.  They are encouraged to ask any questions they might have about the study.  
 
The participant will then read, question, and sign the consent form approved by the Institutional Review Board at Pacific University.  If the 
subject agrees to participate, s/he will be given a copy of the consent form for their record. 
 
If results of the vision exam meet all criteria, the participant will be invited to participate in the second (lens testing) session.  If the results 
do not meet the criteria, his/her participation will be terminated and s/he will be compensated for the first hour of participation.  An 
explanation will be given to the participant as why her participation is terminated, and documented on the consent form.    
2. How will participant assent be obtained and documented?
Not applicable.

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Medical Device Study Information
15 
Institutional Review Board 
2043 College Way | UC Box A-133 | Forest Grove, OR 97116 
(P) 503.352.1478 | (F) 503.352.1447 | (E) irb@pacificu.edu   
(W) www.pacificu.edu/about-us/offices/institutional-review-board
Medical Device Study Information
Study Title
Ocular Adaptation and Visual Performance for Accommodative Contact Lens
Research Personnel
Investigator(s)
Shun-nan Yang, Patrick Caroline, Timothy Poling, Susan Resnick and David Geffen
Faculty Investigator (required for student investigator research)
Medical Device Information
This form is to be used if a medical device, or multiple medical devices, is the subject of study in this protocol. If medical 
devices are being used for their intended and approved purposes and are not the subject of study, please modify your response 
to the Medical Device Question.
1. Clearance and/or Approval and Use Information 
Medical Device #1
Medical Device Name
Accommodative contact lens
PMA Numbers(s) (as applicable)
Not applicable
501(k) Numbers(s) (as applicable)
Not applicable
Additional Information, as needed
Check all that apply. Please attach the product label information, if available, as a separate document on IRBNet (entitled 
“Product Name” - Label Information).
This study involves research on a medical device that is cleared and/or approved for marketing.
The medical device is being used in accordance with its approved indications, with no modifications (on-label use).
The medical device is not being used in accordance with its approved indications (off-label use).
This study involves research on a medical device that has not been cleared and/or approved for marketing.
■

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Medical Device Study Information
16 
2. Investigation Device Exemption (IDE)
Check all that apply.
This study involves an investigation that is exempt from the IDE requirements (21 CFR 812.2(c)).
This study involves an investigation for which an IDE is required.
IDE approval has been obtained from the FDA (please submit as separate document).
IDE approval has not been obtained from the FDA.
IDE approval is automatic because the study is determined to be non-significant risk.
■
3. Significant Risk (SR) or Non-Significant Risk (NSR) Determination
Check all that apply.
This is a SR medical device (21 CFR 812.3(m)) study.
This is a NSR medical device study.
■
A NSR determination has been obtained from the FDA (please submit as separate document).
A NSR determination has not been obtained from the FDA.
■

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Informed Consent
17 
Institutional Review Board 
2043 College Way | UC Box A-133 | Forest Grove, OR 97116 
(P) 503.352.1478 | (F) 503.352.1447 | (E) irb@pacificu.edu   
(W) www.pacificu.edu/about-us/offices/institutional-review-board
Informed Consent
Study Title
Ocular Adaptation and Visual Performance for Accommodative Contact Lens
Research Personnel and Contact Information
Personnel #1
Name
Shun-nan Yang
Role
Principal Investigator
Institution
Pacific University
Program
College of Optometry
Email
shunnan.yang@pacificu.edu
Telephone
(503)352-2852
Scope
Recruitment
Consent Process
Data Collection
Data Analysis (with personally identifiable information)
■
Data Analysis (de-identified data)
■
Other:
Personnel #2
Name
Site Optometrist
Role
Co-Investigator
Institution
Office Name
Program
Email
corresponding email
Telephone
site number
Scope
Recruitment
■
Consent Process
■
Data Collection
■
Data Analysis (with personally identifiable information)
■
Data Analysis (de-identified data)
■
Other:
Study Invitation | Purpose | Location | Dates
You are invited to participate in a study about a specially designed contact lens.  The lens can help people with presbyopia see both near 
and far objects.  You are invited because the lens is mostly likely to help people around your age (40 to 65 years old) see more clearly at 
different viewing distances.  This consent form informs you about the study so you can decide if you should be in the study or not. 
 
The study involves two sessions at [Specific Site] Office.  In the first session, a 40- to 60-minute vision exam will be conducted by an 
optometrist to determine if you can participate in the second session.  If results of the vision exam indicate that you meet all criteria, you 

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Informed Consent
18 
will be invited to participate in the second session.  You can begin the second session immediately after the vision exam session, or 
schedule it on a later date.  We will ask you to confirm your agreement to participate at the beginning of the second session if it is 
scheduled on a later date.  In the second session you will view simple eye charts while wearing the special contact lens.  The testing will last 
about two hours.  You can take breaks during testing when you need it.  We will use several machines to take images of your eyes to 
evaluate how well the lens fits your eyes.  You will be using a chin/forehead rest to keep your head still while we take these pictures.  You 
can withdraw from this study at any time.   
 
This study has been approved by the Institutional Review Board of Pacific University.  It will take place from January 2018 to December 
31, 2018 at [Specific Site Address].  Although results of this study do not directly benefit you, we might find out information that will help 
improve the design of contact lens for people around your age.  
 
You can ask me, [Site Co-investigator], any questions about this study now.  I can answer questions related to the study for you.  You also 
can talk to the principle investigator (PI), Dr. Shun-nan Yang, about this study.  His phone number is 503-352-2852. After all your 
questions have been answered, you can decide if you would like to be in this study or not. 
Participant Characteristics and Exclusionary Criteria
You are qualified to participate in the study if you can satisfy the following requirements: 
• Be between 40 and 75 years of age. 
• Have normal/corrected-to-normal monocular acuity of better than 20/25 for both eyes. 
• Have a pupil diameter ≥ 2.5 mm under room light. 
• Willing and able to wear multifocal contact lenses in both eyes. 
• Have a current optical prescription (obtained less than 2 years ago).  
• Have spherical equivalent correction equal to or higher than -1.00 Diopter and equal to or less than +0.50 Diopter. 
• Have cylindrical correction equal to less than 0.50 Diopter. 
 
You cannot participate in the study if you have any of the following conditions: 
• Have prismatic correction. 
• Have any eye infection, inflammation, disease, or abnormality that prevents contact lens wear within the past 6 months. 
• Have clinically significant ocular pathology (e.g., cataract, keratoconus, dry eye, diabetic retinopathy, or age-related macular degeneration) 
• Have photosensitive disorders, including migraine and seizure.  
• Have binocular dysfunction, including amblyopia (lazy eyes), strabismus, and other binocular diseases. 
Study Materials and Procedures
In the proposed study we plan to recruit and test up to 110 people who are between 40 and 65 years of age and likely have significantly loss 
in their ability to accommodate their crystalline lens in the eyes.   Participants in this study will wear specially designed contact lenses and 
perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles.  These are similar to the typical 
examinations conducted for regular contact lens wearers.  The duration of eye exam and testing are about 3 hours.  Results of this testing 
will be used to evaluate the efficacy of the test lens and to provide additional information for improving its design.  If shown to provide 
adequate eye comfort and intended vision correction, this lens design has the potential of allowing tens of millions of presbyopes to utilize 
contact lenses to improve their functional, everyday vision.
Risks | Risk Reduction Steps | Clinical Alternatives
1. Anticipated Risks and Strategies to Minimize or Avoid Risk
Possible risks during testing include a minimal level of eye symptoms similar to what you would experience in wearing soft contact lenses.  
The symptoms include dry eye and general discomfort but will be short term in nature – probably not extending beyond the testing session. 
There is minimal risk in exposing the participant to 2 hours of testing.   
 
In addition, this experimental contact lens has not been approved or presented to the FDA for approval, as it is still in the development 

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Informed Consent
19 
phase. The sponsor, OneFocus Vision (8358 Sanctuary Lane, Fernandina Beach, FL 32034; Phone number 404-405-0109) has made 
reasonable efforts to test biologically active elements and have found no evidence that they would cause infection or irritation.  
Additionally, the investigator and sponsor agree that this lens is biologically similar to other products on the market.  However, you as a 
participant need to know that this device is not currently regulated by the FDA, although it may be in the future. If you would like to have 
laboratory results documenting the safety of the lens, we can provide them to you.  
 
2. Unknown Risks
It is possible that participation in this study may expose you to currently unforeseeable risks.
3. Advantageous Clinical Alternatives
The specially designed contact lens is an experimental design but made of the same material as currently commercially available contact lens 
(hydrogel).  Currently the alternative to wearing this kind of special lens is to wear eye glasses or contact lens with single- or multi-focal 
distances.  
Adverse Event Handling and Reporting Plan
In the event that you become sick, injured, distressed, or otherwise uncomfortable as a result of your involvement in the research study, 
you may stop your participation immediately. If such an event occurs, promptly notify the principal investigator or the Pacific University 
Institutional Review Board.
If the investigator(s) become aware of an adverse event, the IRB office will be notified by the next normal business day for any minor 
events, such as persistent visual or physical discomfort you might experience, and within 24 hours for major events such as severe 
physical illness.
If you experience or are directly affected by an adverse event, you will be given the opportunity to withdraw any data collected from 
you during the study up to the point of the publication of the study results.
Direct Benefits and/or Payment to Participants
a. Benefit(s)
We expect no direct benefits to you. Depending on the findings, benefits may accrue to the general population of contact lens wearers 
from which this sample is drawn.
b. Payment(s) or Reward(s)
You will be compensated for $50 for the 1-hour vision exam, and additional $100 for the 2-hour of lens wearing and testing).  You will only 
receive $50 if you participate in the vision exam session but are not invited back for the second lens testing session.  You will need to 
provide personally identifiable information in order to receive the payment.  If you are a Pacific University employee, you payment will be 
reported to Payroll (depending on the value of the award/prize, it may be taxable).   
Promise of Privacy
All recorded images, examination records, and testing results will be identified by only numbers and kept in a locked file cabinet.  Only the 
PI will have access to the file cabinet.  Consent forms will be kept separately from study data.  Results from your testing will be reported as 
grouped data.  Any images or videos from the study will be prepared in a way so that you cannot be identified, even by the PI.  Through 
use of code numbers, your identity will be shielded from subsequent data report.  Study data and consent forms will be maintained securely 
for three years after the completion of the study or the date of publication on a journal.  After the deadline, the date and document will be 
destroyed. 

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Informed Consent
20 
 
A description of this clinical investigation will be available on http://www.clinicaltrials.gov, as required by U.S. law. This website will not 
include information that can identify you. At most, the website will include a summary of the results. You can search this website at any 
time.   
 
As part of ongoing compliance efforts, the Food and Drug Administration (FDA) may inspect any and all records pertaining to this study. 
FDA auditors maintain strict confidentiality of all records reviewed.   
 
In addition, efforts will be made to limit use or disclosure of your personal information to persons approved as study staff.  We cannot 
promise complete confidentiality. Organizations that may inspect and copy your information include the IRB of Pacific University, and 
representatives responsible for the management or oversight of this study. The sponsor will have limited access to data, whereas monitors, 
auditors, the IRB, and the FDA will be granted direct access to your research records to conduct and oversee the study.  We may publish 
the results of this research.  However, we will keep your name and other identifying information confidential. 
Medical Care and Compensation in the Event of Accidental Injury
N/A
During your participation in this project it is important to understand that you are not a patient or client of Pacific University clinic or 
other investigative clinic sites, nor will you be receiving complete eye care as a result of your participation in this study. If you are injured 
during your participation in this study and it is not due to negligence by Pacific University, the investigator(s), or any organization 
associated with the research, you should not expect to receive compensation or medical care from Pacific University, the investigator(s), or 
any organization associated with the study. If you are injured and it directly is related to your participation in this study as a research 
subject, please contact the Pacific University Institutional Review Board at 503-352-1478.
Voluntary Nature of the Study
Your decision whether or not to participate will not affect your current or future relations with Pacific University and associated testing 
clinics. If you decide to participate, you are free to not answer any question or withdraw at any time up until the study data is published 
without prejudice or negative consequences. If you choose to withdraw after beginning the study but prior to publication, you will be 
compensated for the time you have spent and the data collected from you will be destroyed. If significant new findings develop (or are 
discovered) during the course of this research that could impact your decision to continue participation, such findings will be shared with 
you and you will be given the opportunity to withdraw from the study.
Contacts and Questions
The investigator(s) will be happy to answer any questions you may have at any time during the course of the study. If you are 
not satisfied with the answers you receive, please call the Pacific University Institutional Review Board at 503-352-1478 to 
discuss your questions or concerns further. If you have questions about your rights as a research subject, or if you experience a 
research-related injury of any kind, please contact the investigator(s) and/or the IRB office. All concerns and questions will be 
kept in confidence.
Statement of Consent
YES NO
I am 18 years of age or over.
All my questions have been answered.
I have read and understand the description of my participation duties.
I have been offered a copy of this form to keep for my records.
I voluntarily agree to participate in this study and understand that I may withdraw at any time without consequence.

Institutional Review Board | FWA: 00007392 | IRB: 0004173
IRB Number: 120-14 NCT#: 02923232  
Approved: 10/01/2017
Post-Approval Request(s):
Approval Expires: 09/30/2018
Informed Consent
21 
Signature
Date
Printed Full Name
Study Role
Participant
Signature
Date
Printed Full Name
Study Role*
*This individual must be trained in obtaining informed consent and have authorization from the principal investigator and/or faculty advisor to do so.