Conditions: Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis) Central Retinal Vein Occlusion With Macular Edema Exudative Age-Related Macular Degeneration, Unspecified Eye Cystoid Macular Edema Ocular Surface Disease Dry Eye Sensation Eye Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 124
Healthy volunteers: yes

Brief summary:
Background and Objective: To evaluate the efficacy of cooled versus room temperature artificial tears in reducing post intravitreal injection (IVI) ocular discomfort.

Patients and Methods: Patients receiving IVI were randomized to either cooled or room temperature tears intervention groups. Both groups rated their ocular discomfort following IVI before intervention and again after administration of cooled or room temperature tears.

Detailed description:

Arms:
arm 1: Stored at 4 degree Celsius arm 2: Stored at 25 degree Celsius

Interventions: intervention 1: Refresh Plus Preservative-free Lubricant Eye Drops
Intervention descriptions: intervention 1: Refresh Plus Preservative-free Lubricant Eye Drops at either 4 or 25 degree Celsius

Protocol document:
Prot_001.pdf: 
1 
 
Study Title: Randomized Controlled Study of Cooled Versus Room-Temperature Artificial Tears for 
Reducing Surface Irritation Following Intravitreal Injection 
NCT05832996 
Document Date: 04/25/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


2 
 
Project Title: The Effect of Cooled Artificial Tears in Reducing Ocular Surface Irritation after 
Povidone-Iodine Preparation of Intravitreal Injection. 
Principle Investigator: Douglas Jin, MD 
Purpose:  
The use of Povidone-iodine (PVI) is the standard of care when preparing for intravitreal injections. 
However, PVI is also known to be toxic to the corneal epithelium and delays ocular surface healing. 
Although guidelines on pre and peri-injection antiseptic techniques are well-studied, there has 
been a relative lack of consensus on ocular surface management to reduce the severity and 
duration of post-injection pain and discomfort. Patients frequently report post-injection ocular 
discomfort (e.g. tearing, burning, redness, and foreign body sensation) similar to symptoms of dry 
eye disease, and the main culprit is the application of PVI to prevent eye infections. Many have 
studied the effect of cooling eye drops, such as certain glaucoma and anesthetic drops to alleviate 
their initial stinging sensation upon instillation. Similarly, people have tried cooling the eye itself as 
an effective numbing effect to dull the pain associated with intravitreal injections. Oftentimes 
patients are advised to try using artificial tears on an as-needed basis to alleviate any dry-eye 
sensation post-injection, and we propose that cooling the artificial tears will further reduce 
patients' ocular discomfort level associated with eye injections. 
Study aims or hypotheses:  
Does the use of cooled artificial tears (4 C) reduce ocular discomfort compared to that of room-
temperature artificial tears (~23C) measured by the standard questionnaires (e.g. Ocular Surface 
Disease Index and subjective stinging feeling scale) in patients who receive intravitreal injections? 
Procedure:  
Any patient who comes to the injection clinic and reports subjective sensation of ocular discomfort 
will be allowed to participate in the study. The subject will be randomized into either the room-
temperature group or the cooled group, and they will use the respective artificial tears for up to 12 
hours in the immediate post-injection period. A telephone survey will be administered within 48 
hours of the clinic visit to administer a standard questionnaire to assess their ocular discomfort 
level. 
Background and significance: 
Intravitreal injection (IVI) is the most commonly performed ophthalmic procedure (2.5 million in 
2011) in the United States. Povidone-iodine (PVI) has been widely studied as an antiseptic agent 
and its application is considered the standard of care when preparing for IVI. PVI is also known to 
be toxic to the corneal epithelium and delays ocular surface healing. Although guidelines on pre 
and peri-injection antiseptic techniques are well-studied, there has been a relative lack of 
consensus on ocular surface management to reduce the severity and duration of post-injection 
pain and discomfort. Patients frequently report post-injection ocular discomfort (e.g. tearing, 
burning, redness, and foreign body sensation) similar to symptoms of dry eye disease. Many have 
studied the effect of cooling eye drops, such as certain glaucoma and anesthetic drops to alleviate 
their initial stinging sensation upon instillation. Similarly, people have tried cooling the eye itself as 


3 
 
an effective numbing effect to dull the pain associated with intravitreal injections. Oftentimes 
patients are advised to try using artificial tears on an as-needed basis to alleviate any dry-eye 
sensation post-injection, and we propose that cooling the artificial tears will further reduce 
patients' ocular discomfort level associated with eye injections. 
Target Enrollment: 300 
Age of Subjects: 18-105 years 
Inclusion Criteria:  
Patients were eligible if they were receiving standard intravitreal injections for their exudative age-
related macular degeneration, cystoid macular edema, diabetic macular edema, proliferative 
diabetic retinopathy, retinal vein occlusion with macular edema, or retinal neovascularization.  
Exclusion criteria 
• 
Inability or lack of willingness to participate in the study 
• 
Active ocular infection including infectious uveitis 
• 
First time receiving intravitreal injection 
• 
Those who reported never having ocular discomfort following intravitreal injections on the 
pre-injection questionnaire 
• 
Less than 18 years of age. 
Arms and Interventions:  
 
 
 
 
 
 
 
 
Outcome Measure:  
1) The Efficacy of Cooled Versus Room Temperature Artificial Tears in Reducing Post 
Intravitreal Injection Ocular Discomfort as Measured by Pain Scale Survey. The level of 
subjectively reported pain scale from 1 to 10, where 1 is minimal pain and 10 is extreme 
pain measured within 72 hours of the intervention. 
 
 
Arms 
Assigned Interventions 
Experimental: Cooled artificial tear 
group 
Stored at 4 degree Celsius 
Drug: Refresh Plus Preservative-free Lubricant Eye Drops 
Refresh Plus Preservative-free Lubricant Eye Drops at 
either 4 or 25 degree Celsius 
Active Comparator: Room temperature 
artificial tear group 
Stored at 25 degree Celsius 
Drug: Refresh Plus Preservative-free Lubricant Eye Drops 
Refresh Plus Preservative-free Lubricant Eye Drops at 
either 4 or 25 degree Celsius 


4 
 
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factor (VEGF) injection: A comprehensive review. Int J Retina Vitreous. 2015;1:9-015-0010-y. 
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2. Patel SN, Gangaputra S, Sternberg P,Jr, Kim SJ. Prophylaxis measures for postinjection 
endophthalmitis. Surv Ophthalmol. 2020. 
3. Grzybowski A, Kanclerz P, Myers WG. The use of povidone-iodine in ophthalmology. Curr Opin 
Ophthalmol. 2018;29(1):19-32. 
4. Avery RL, Bakri SJ, Blumenkranz MS, et al. Intravitreal injection technique and monitoring: 
Updated guidelines of an expert panel. Retina. 2014;34 Suppl 12:S1-S18. 
5. Hinkle JW, Wykoff CC, Lim JI, et al. “Iodine allergy” and the use of povidone iodine for 
endophthalmitis prophylaxis. Journal of VitreoRetinal Diseases. 2020;4(1):65-68. 
6. Wykoff CC, Flynn HW,Jr, Han DP. Allergy to povidone-iodine and cephalosporins: The clinical 
dilemma in ophthalmic use. Am J Ophthalmol. 2011;151(1):4-6 
7. Laude A, Lim JW, Srinagesh V, Tong L. The effect of intravitreal injections on dry eye, and 
proposed management strategies. Clin Ophthalmol. 2017;11:1491-1497. 
8. Saedon H, Nosek J, Phillips J, Narendran N, Yang YC. Ocular surface effects of repeated 
application of povidone iodine in patients receiving frequent intravitreal injections. Cutan Ocul 
Toxicol. 2017;36(4):343-346. 
9. Chaturvedi R, Wannamaker KW, Riviere PJ, Khanani AM, Wykoff CC, Chao DL. Real-world trends 
in intravitreal injection practices among american retina specialists. Ophthalmol Retina. 
2019;3(8):656-662. 
10. Green-Simms AE, Ekdawi NS, Bakri SJ. Survey of intravitreal injection techniques among retinal 
specialists in the united states. Am J Ophthalmol. 2011;151(2):329-332. 
11. Grzybowski A, Told R, Sacu S, et al. 2018 update on intravitreal injections: Euretina expert 
consensus recommendations. Ophthalmologica. 2018;239(4):181-193. 
12. Ridder WH,3rd, Oquindo C, Dhamdhere K, Burke J. Effect of povidone iodine 5% on the cornea, 
vision, and subjective comfort. Optom Vis Sci. 2017;94(7):732-741. 
13. Marcet MM, Shtein RM, Bradley EA, et al. Safety and efficacy of lacrimal drainage system plugs 
for dry eye syndrome: A report by the american academy of ophthalmology. Ophthalmology. 
2015;122(8):1681-1687. 
14. Jehangir N, Bever G, Mahmood SM, Moshirfar M. Comprehensive review of the literature on 
existing punctal plugs for the management of dry eye disease. J Ophthalmol. 2016;2016:9312340. 
15. Ngo W, Situ P, Keir N, Korb D, Blackie C, Simpson T. Psychometric properties and validation of 
the standard patient evaluation of eye dryness questionnaire. Cornea. 2013;32(9):1204-1210. 


5 
 
16. Pflugfelder SC, Solomon A, Stern ME. The diagnosis and management of dry eye: A twenty-five-
year review. Cornea. 2000;19(5):644-649. 
17. Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other 
dry eye tests. Cornea. 2003;22(7):640-650. 
18. Miller KL, Walt JG, Mink DR, et al. Minimal clinically important difference for the ocular surface 
disease index. Arch Ophthalmol. 2010;128(1):94-101. 
19. Asiedu K, Kyei S, Mensah SN, Ocansey S, Abu LS, Kyere EA. Ocular surface disease index (OSDI) 
versus the standard patient evaluation of eye dryness (SPEED): A study of a nonclinical sample. 
Cornea. 2016;35(2):175-180. 
20. Segal O, Segal-Trivitz Y, Nemet AY, Cohen P, Geffen N, Mimouni M. Anxiety levels and perceived 
pain intensity during intravitreal injections. Acta Ophthalmol. 2016;94(2):203-204. 
21. Vaze A, Fraser-Bell S, Gillies M. Reasons for discontinuation of intravitreal vascular endothelial 
growth factor inhibitors in neovascular age-related macular degeneration. Retina. 2014;34(9):1774-
1778. 
22. Blaha GR, Tilton EP, Barouch FC, Marx JL. Randomized trial of anesthetic methods for 
intravitreal injections. Retina. 2011;31(3):535-539. 
23. Davis MJ, Pollack JS, Shott S. Comparison of topical anesthetics for intravitreal injections : A 
randomized clinical trial. Retina. 2012;32(4):701-705. 
24. Dohlman TH, Lertsuwanroj B, D'Amico DJ, Ciralsky JB, Kiss S. Evaluation of signs and 
symptoms of ocular surface disease after intravitreal injection. Acta Ophthalmol. 
2019;97(8):e1154-e1156. 
25. Shibata Y, Tanaka Y, Tomita T, et al. Evaluation of corneal damage caused by iodine 
preparations using human corneal epithelial cells. Jpn J Ophthalmol. 2014;58(6):522-527. 
26. Klenkler B, Sheardown H, Jones L. Growth factors in the tear film: Role in tissue maintenance, 
wound healing, and ocular pathology. Ocul Surf. 2007;5(3):228-239. 
27. Ervin AM, Law A, Pucker AD. Punctal occlusion for dry eye syndrome: Summary of a cochrane 
systematic review. Br J Ophthalmol. 2019;103(3):301-306. 
28. Pflugfelder SC. Tear dysfunction and the cornea: LXVIII edward jackson memorial lecture. Am J 
Ophthalmol. 2011;152(6):900-909.e1. 
29. Crabb MG, Liu E, Freeman A, et al. The intravitreal injection pain study: A randomized control 
study comparing subjective pain with injection technique. Acta Ophthalmol. 2019;97(8):e1153-
e1154. 
30. Jandorf S, Krogh Nielsen M, Sorensen TL. Irrigating the eye after intravitreal injection reduces 
epithelial damage but not patient discomfort. Acta Ophthalmol. 2019;97(4):e670-e671. 
31. Bitton E. Response to re: Does the temperature of an artificial tear affect its comfort? Clin Exp 
Optom. 2019;102(2):191-192. 


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32. Bitton E, Crncich V, Brunet N. Does the temperature of an artificial tear affect its comfort? Clin 
Exp Optom. 2018;101(5):641-647. 
33. Bozic M, Stojkovic M, Knezevic M, Marjanovic I, Bobic-Radovanovic A. Is the use of refrigerated 
fixed combination of dorzolamide 2%-timolol 0.5% (COSOPT) associated with less ocular 
discomfort: A pilot study. J Ocul Pharmacol Ther. 2018;34(9):642-646. 
34. Fujishima H, Yagi Y, Shimazaki J, Tsubota K. Effects of artificial tear temperature on corneal 
sensation and subjective comfort. Cornea. 1997;16(6):630-634. 
35. Hu Youwei J, Chang B. Effect of cooling proparacaine 0.5% eye drops on patient's comfort 
during instillation. Eye (Lond). 2015;29(8):1112-1113. 
36. Karkkainen TR. The effect of refrigeration on the osmolality and pH of nonpreserved artificial 
tears containing carboxymethylcellulose. Optom Vis Sci. 2001;78(1):37-39. 
37. McMonnies CW. Re: Does the temperature of an artificial tear affect its comfort? Clin Exp 
Optom. 2019;102(2):191. 
38. Meduri A, Bergandi L, Oliverio GW, et al. The cold eye irrigation BSS solution used during 
phacoemulsification reduces post-surgery patients discomfort preventing the inflammation. Eur J 
Ophthalmol. 2021:11206721211018377. 
39. Soltani AE, Ganji M, Goodarzi M, Moghimi S. Cooling tetracaine to reduce pain of instillation 
before surgery. Eye (Lond). 2009;23(6):1470. 

ICF_003.pdf: 
Study Title: Randomized Controlled Study of Cooled Versus Room-Temperature Artificial Tears for 
Reducing Surface Irritation Following Intravitreal Injection  
NCT05832996  
Document Date: 04/25/2022 


INFORMED CONSENT DOCUMENT
Project Title:
The Effect of Cooled Artiﬁcial Tears in Reducing Ocular Surface Irritation after 
Povidone-Iodine Preparation of Intravitreal Injection 
Principal Investigator:
Haoxing (Douglas) Jin
Research Team Contact:
Douglas Jin, MD;  Email: douglas-jin@uiowa.edu; Phone: 319-356-0382  
This consent form describes the research study to help you decide if you want to participate.  This form 
provides important information about what you will be asked to do during the study, about the risks and 
beneﬁts of the study, and about your rights as a research subject.  
If you have any questions about or do not understand something in this form, you should ask the 
research team for more information.  
You should discuss your participation with anyone you choose such as family or friends.  
Do not agree to participate in this study unless the research team has answered your questions 
and you decide that you want to be part of this study. 
WHAT IS THE PURPOSE OF THIS STUDY?
This is a research study.  We are inviting you to participate in this research study because you routinely 
receive an intravitreal injection in your eye(s) as part of your eye care.  Your eye surface is prepared 
with povidone-iodine (PVI) to prevent infection prior to the intravitreal injection.  The povidone-iodine 
can cause discomfort, tearing, burning, redness, dryness and stinging sensations. After the procedure 
most patients receive saline (artiﬁcial drops) to rinse out the eye. This study plans to use the artiﬁcial eye 
drops that are either cooled down or at room temperature. 
The purpose of this research study is to see if the temperature of saline eye drops used to ﬂush out the 
povidone-iodine (PVI) after your intravitreal injection may improve your eye comfort level. 
HOW MANY PEOPLE WILL PARTICIPATE?
Approximately 200  people will take part in this study conducted by investigators at the University of 
Iowa. 
HOW LONG WILL I BE IN THIS STUDY?
If you agree to take part in this study, your involvement will last 1 visit and a follow up phone call 12 to 
72 hours after your clinic visit.  Each will take 15 minutes.  
WHAT WILL HAPPEN DURING THIS STUDY?


At your UIHC Ophthalmology Retina Service Injection Clinic appointment, you will be invited to 
participate in a research project prior to your intravitreal injection.  If you decide to enroll in the study, 
the following will occur. 
You will be asked a short questionnaire about your eye(s) surface comfort before your injection. After 
your intravitreal injection you will receive artiﬁcial tear drops to rinse your eye(s). They will are either 
be at room temperature or cooled down (refrigerated).  You will randomly be assigned which eye drops 
will be given. This means the group your assigned is determined purely by chance, like ﬂipping a coin. 
You will have a 50/50 chance of receiving the cooled down (refrigerated) or room temperature drops. 
You and the technician will know which type of eye drops you were assigned.  The physician will not 
know. Most patients use artiﬁcial tears after injection per instruction, as needed, to alleviate any eye 
surface discomfort. This will take 15 minutes of you time.
A research team member will telephone you 12 to 72 hours after your clinic visit.  You will be asked the 
questions about your eye surface comfort after the injection. You may decline to answer any questions 
you feel uncomfortable answering. The telephone call will take 15 minutes.
 
After the follow up telephone call you will have completed your participation in the study.
Data Storage for Future Use 
As part of this study, we are obtaining data from you.  We would like to study your data  in the future, 
after this study is over.  Your sample, information, and/or data may be placed in a central repository or 
other national repositories sponsored by the National Institutes of Health or other Federal agencies. If 
this happens, it may be stripped of identiﬁers (such as name, date of birth, address, etc).  Other qualiﬁed 
researchers who obtain proper permission may gain access to your sample and/or data for use in 
approved research studies that may or may not be related to in the purpose of this study.  
The procedure we might want to use to study may not even exist at this time.  Therefore, we are asking 
for your permission to store your data so that we can study them in the future.  These future studies may 
provide additional information that will be helpful in understanding eye condition, but it is unlikely that 
what we learn from these studies will have a direct beneﬁt to you.  It is possible that your data might be 
used to develop products tests, or discoveries that could be patented and licensed.  In some instances, 
these may have potential commercial value and may be developed by the Investigators, University of 
Iowa, commercial companies, organizations funding this research, or others that may not be working 
directly with this research team.  However, donors of data do not retain any property rights to the 
materials.  Therefore, there are no plans to provide ﬁnancial compensation to you should this occur.  
 
Your data will be stored without your name or any other kind of link that would enable us to identify 
which sample(s) are yours.  Therefore, if you give permission to store your data , it will be available for 
use in future research studies indeﬁnitely and cannot be removed.
WHAT ARE THE RISKS OF THIS STUDY?
You may experience one or more of the risks indicated below from being in this study. In addition to 


these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this 
study.  There is a minimal risk of scratching the eye surface (cornea) during self-administration of the 
saline artiﬁcial drops. Most patients already use artiﬁcial tears after the injection, as needed, per 
instruction to alleviate any ocular surface stinging sensation.
WHAT ARE THE BENEFITS OF THIS STUDY?
You will not beneﬁt from being in this study.
However, we hope that, in the future, other people might beneﬁt from this study because 
WILL IT COST ME ANYTHING TO BE IN THIS STUDY?
You will not have any costs for being in this research study.
            
You and/or your medical/hospital insurance carrier will remain responsible for your regular medical care 
expenses.
WILL I BE PAID FOR PARTICIPATING?
You will not be paid for being in this research study.  
WHO IS FUNDING THIS STUDY?
The University and the research team are receiving no payments from other agencies, organizations, or 
companies to conduct this research study.
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY?
If you are injured or become ill from taking part in this study, medical treatment is available at the 
University of Iowa Hospitals and Clinics.
The University of Iowa does not plan to provide free medical care or payment for treatment of any 
illness or injury resulting from this study unless it is the direct result of proven negligence by a 
University employee. 
If you experience a research-related illness or injury, you and/or your medical or hospital insurance 
carrier will be responsible for the cost of treatment.
WHAT ABOUT CONFIDENTIALITY?
We will keep your participation in this research study conﬁdential to the extent permitted by law. 
However, it is possible that other people such as those indicated below may become aware of your 
participation in this study and may inspect and copy records pertaining to this research.  Some of these 


records could contain information that personally identiﬁes you. 
•
federal government regulatory agencies, 
•
the U.S. Food and Drug Administration 
•
auditing departments of the University of Iowa, and 
•
the University of Iowa Institutional Review Board (a committee that reviews and approves 
research studies) 
 
To help protect your conﬁdentiality, we will store the research data on University of Iowa compliant 
device with password protection and deidentify your data with a code that does not directly link you 
back to the study. If we write a report or article about this study or share the study data set with others, 
we will do so in such a way that you cannot be directly identiﬁed.
The University of Iowa Hospitals and Clinics generally requires that we document your participation in 
research occurring in a University of Iowa Health Care facility.  This documentation will be in either 
your medical record or a database maintained on behalf of the institution reﬂecting that you are 
participating in this study. The information included will provide contact information for the research 
team as well as information about the risks associated with this study. We will keep this Informed 
Consent Document in our research ﬁles; it will not be placed in your medical record chart.
WILL MY HEALTH INFORMATION BE USED DURING THIS STUDY?
The Federal Health Insurance Portability and Accountability Act (HIPAA) requires University of Iowa 
Health Care to obtain your permission for the research team to access or create “protected health 
information” about you for purposes of this research study.  Protected health information is information 
that personally identiﬁes you and relates to your past, present, or future physical or mental health 
condition or care.  We will access or create health information about you, as described in this document, 
for purposes of this research.  Once University of Iowa Health Care has disclosed your protected 
health information to us, it may no longer be protected by the Federal HIPAA privacy regulations, but 
we will continue to protect your conﬁdentiality as described under “Conﬁdentiality.”
We may share your health information related to this study with other parties including federal 
government regulatory agencies, the University of Iowa Institutional Review Boards and support staff, .
You cannot participate in this study unless you permit us to use your protected health information.  If 
you choose not to allow us to use your protected health information, we will discuss any non-research 
alternatives available to you.  Your decision will not affect your right to medical care that is not 
research-related.  Your signature on this Consent Document authorizes University of Iowa Health Care 
to give us permission to use or create health information about you.
Although you may not be allowed to see study information until after this study is over, you may be 
given access to your health care records by contacting your health care provider. Your permission for us 
to access or create protected health information about you for purposes of this study has no expiration 
date. You may withdraw your permission for us to use your health information for this research study by 
sending a written notice to Dr. Jonathan F Russell or Dr. Douglas Jin, MD, University of Iowa 
Hospitals & Clinics, Department of Ophthalmology & Visual Sciences, 200 Hawkins Drive – PFP, 
Iowa City IA 52242.   However, we may still use your health information that was collected before 


withdrawing your permission.  Also, if we have sent your health information to a third party, such as the 
study sponsor, or we have removed your identifying information, it may not be possible to prevent its 
future use.  You will receive a copy of this signed document.
IS BEING IN THIS STUDY VOLUNTARY?
Taking part in this research study is completely voluntary.  You may choose not to take part at all.  If you 
decide to be in this study, you may stop participating at any time.  If you decide not to be in this study, or 
if you stop participating at any time, you won’t be penalized or lose any beneﬁts for which you 
otherwise qualify.
What if I Decide to Drop Out of the Study?
If you decide to leave the study early, we will ask you to complete the follow up telephone call.
Will I Receive New Information About the Study while Participating?
If we obtain any new information during this study that might affect your willingness to continue 
participating in the study, we’ll promptly provide you with that information.
Can Someone Else End my Participation in this Study?
Under certain circumstances, the researchers might decide to end your participation in this research 
study earlier than planned.  This might happen because in our judgment it would not be safe for you to 
continue.
WHAT IF I HAVE QUESTIONS?
We encourage you to ask questions.  If you have any questions about the research study itself, please 
contact: Dr. Jonathan F. Russell or Dr. Douglas Jin at 319-356-3185; and ask for the ophthalmology 
fellow or resident on call and to tell operator you are a research subject.    
If you have questions, concerns, or complaints about  your rights as a research subject or about research 
related injury, please contact the Human Subjects Ofﬁce, 105 Hardin Library for the Health Sciences, 
600 Newton Rd, The University of Iowa, Iowa City, IA  52242-1098, (319) 335-6564, or e-mail 
irb@uiowa.edu.  General information about being a research subject can be found by clicking “Info for 
Public” on the Human Subjects Ofﬁce web site, http://hso.research.uiowa.edu/. To offer input about your 
experiences as a research subject or to speak to someone other than the research staff, call the Human 
Subjects Ofﬁce at the number above.
This Informed Consent Document is not a contract. It is a written explanation of what will happen 
during the study if you decide to participate. You are not waiving any legal rights by signing this 
Informed Consent Document. Your signature indicates that this research study has been explained to 
you, that your questions have been answered, and that you agree to take part in this study.  You will 
receive a copy of this form.


Subject's Name (printed):  __________________________________________________________
__________________________________________
_______________________________
(Signature of Subject)
(Date)
Statement of Person Who Obtained Consent
I have discussed the above points with the subject or, where appropriate, with the subject’s legally 
authorized representative.  It is my opinion that the subject understands the risks, beneﬁts, and 
procedures involved with participation in this research study.
__________________________________________
_______________________________
(Signature of Person who Obtained Consent)
(Date)