Clinical trial NCT03864133
Conditions: Cataract
Sponsor: Wake Forest University Health Sciences
Start date: 2019-07-08; Completion date: 2021-08-16
Enrollment: 94 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluates the effect of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery. Participants will receive infusions of Phenylephrine/Ketorolac during surgery instead of receiving topical NSAID drops pre and post operatively.

Detailed description:
Topical NSAIDs have been known to reduce post-operative macular edema, inflammation and pain in patients undergoing cataract surgery. Routine cataract surgery without the protection of topical NSAIDs results in an increase of the number of patients with macular edema and macular thickening.

Omidria (phenylephrine and ketorolac injection 1%/0.3%) infusion is used in patients during cataract surgery to decrease post-operative pain and inflammation. It is also indicated to maintain pupil dilation during cataract surgery.

This study will evaluate whether treating patients with Omidria during cataract surgery will control post-operative pain and inflammation as well as reduce or eliminate macular edema without the use of adjunctive topical NSAIDs.

Arms: arm 1: Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.
Interventions: intervention 1: Omidria
Intervention descriptions: intervention 1: Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.

Protocol documents:
Prot_SAP_001.pdf: 
 
 
Title:  No Drop Cataract Surgery: The effect of Intraocular Phenylephrine/Ketorolac 
Infusion on Retinal Thickness and Macular Edema in Cataract Surgery 
 
 
Protocol ID:  IRB00050415 
 
 
 
NCT03864133 
 
 
 
IRB-Approved Date:  3/12/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Study Title: No Drop Cataract Surgery: The effect of Intraocular 
Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract 
Surgery.   
 
Principle Investigator, Co-investigator(s): Keith Walter MD, Ken Weinlander, MD; 
Amber Hoang, MD 
 
Sponsor or funding source: Omeros Corporation, Seattle WA.  
 
Background, Rationale and Context 
 
Patient compliance and insurance coverage with eye drops in cataract surgery has become 
a major hurdle in successful cataract surgery. One of the major complications of cataract 
surgery is post-operative pain and cystoid macular edema (CME).1,2 Multiple topical 
drugs have been used to prevent pain and macular edema in cataract surgery and include 
both topical steroid eye drops as well as non-steroidal anti-inflammatory agents 
(NSAIDs). Issues with these drops include patient difficulty in application, compliance, 
generic substitution and insurance coverage. A large percentage of patients aren’t able to 
afford these drops or often aren’t covered by their insurance. In addition, pharmacists 
often substitute the intended therapy for a generic version or inadequate drug alternative.3 
Recently, Omidria (phenylephrine and ketorolac injection 1% / 0.3%) was FDA approved 
for post-operative pain and inflammation in patients undergoing cataract surgery. It is 
also indicated to maintain pupil dilation during cataract surgery, and is therefore the main 
reason it is used. Omidria is not a topical drug but a constant infusion of phenylephrine 
and ketorolac added to the irrigate used during cataract surgery.  
 
Topical NSAIDs have been known to reduce post-operative CME as well as control pain 
and inflammation, whether alone or with a steroid.4 Reduction of CME is a major goal of 
cataract surgery safety. Typically, routine cataract surgery without the protection of a 
topical NSAID results in 3-4 percent of patient with reduced visual acuity from CME and 
up to 30% with macular thickening.4 Prostaglandins formed as a result of the activation 
of the inflammatory cascade during cataract surgery have been implicated in producing 
pain, inflammation and macular edema.5 Prostaglandin formation is drastically reduced 
by NSAIDs via inhibition of cyclo-oxygenase enzymes (COX 1&2)6. In animal studies, 
sustained suppression of COX enzymes has been shown in all ocular tissues measured up 
to 12 hours after cataract surgery with the use of Omidria.7 
 
All FDA guided studies regarding approval of a topical NSAID, have included a control 
arm where no anti-inflammatory agents are used. Typically, the control arm subjects 
require a rescue drug at 2-8%, despite having more anterior chamber inflammation than 
the study subjects.8 
 
We propose to observe whether treating patients with Omidria (phenylephrine and 
ketorolac injection 1% / 0.3%) during cataract surgery, will not only control post-
operative pain and inflammation but also reduce or eliminate cystoid macular edema 
without adjunctive topical NSAIDs. Potentially all of Dr. Walter’s patients undergoing 


cataract surgery would be recruited by a study team member, as Omidria is beneficially 
in maintaining pupil dilation during cataract surgery, and makes the surgery less risky. 
Only patients which meet an exclusion criterion, such as an allergy to NSAIDs, would 
not be recruited to participate in the study.  
 
Objectives 
 
Primary Objective:  To determine whether intracameral infusion of Omidria is sufficient 
alone to prevent post-operative CME and macular thickening. 
• Hypothesis 1: The administration of Omidria will be sufficient to reduce 
macular thickening without topical NSAIDs or corticosteroids. 
• Hypothesis 2: The administration of Omidria will be sufficient to prevent 
post-operative cystoid macular edema (CME) after routine cataract 
surgery.  
 
Secondary Objective: To observe whether any patients need additional topical therapy 
besides the intraoperative medication.  
• Hypothesis 1.  The administration of Omidria during cataract surgery will 
preclude any additional need for topical anti-inflammatory drops. 
 
Methods and Measures  
 
• Design 
 
A prospective interventional study looking at whether Omidria infusion alone during cataract 
surgery is effective at eliminating post-operative cystoid macular edema and/or macular 
thickening. We will recruit 200 volunteers undergoing elective routine cataract surgery. Patients 
may elect to enroll one or both eyes as desired, with both eyes undergoing surgery a week or two 
apart according to standard cataract surgery protocol. Patients will have no topical anti-
inflammatory drops used or provided during the perioperative period. Macular scans via OCT 
will be taken pre-operatively for baseline measurements, then at about 2 weeks and 6 weeks post-
operatively. 
 
We will collect the following demographic data:  age, gender, and race. In addition, the presence 
of macular cysts will be recorded, as well as central macular thickness. Best corrected spectacle 
acuity will be recorded as well and all data will be stored on a password protected and encrypted 
computer.  
 
• Setting 
 
The study will be performed at Davie Medical Center at Bermuda Run and will only 
involve patients undergoing cataract surgery by Dr. Walter. 
 
Subject selection criteria  
 


Subjects will be recruited through direct asking by a study team member (not Dr. Walter) at the 
time of cataract diagnosis and selected to participate based on the following inclusion and 
exclusion criteria.  
 
• Inclusion criteria:    
o Adults age 55-90 years with visual significant cataracts in one or both eyes.   
o Healthy individuals able to tolerate outpatient cataract surgery under local 
anesthesia via either phacoemulsification and/or femtosecond assisted cataract 
surgery. Well-controlled diabetes, hypertension will be included.  
o Females of childbearing potential must agree to use a reliable method of birth 
control while participating in this study. Reliable methods of birth control are: 
abstinence, oral contraceptives, intrauterine device (IUD), DepoProvera, tubal 
ligation or vasectomy of the partner (with confirmed negative sperm counts) 
in monogamous relationship (same partner). An acceptable, although less 
reliable, method involves the careful use of condoms and spermicidal foam or 
gel and/or cervical cap or sponge. A pregnancy test is required at least 10 days 
from the last normal menstrual period, if the patient is a sexually active female 
of childbearing potential. 
 
 
• Exclusion criteria:  
o Allergy to Phenylephrine or NSAIDs.  
o Inability to sit steady and upright for the OCT.  
o Complications during surgery, including posterior capsular rupture, vitreous 
loss, zonular dialysis, or iris trauma.  
o Macular thickness above 300 microns at baseline 
o Currently taking a prostaglandin analogue  
o Presence of an epiretinal membrane on the preoperative OCT.  
o Retained lens fragment post-operatively.  
o Inability to return for follow appointments 
o Female patients who are pregnant, lactating or planning to become pregnant 
during the course of treatment.  
 
Sample size: 200 patients total.  
 
 
Study Procedure  
 
• 
Informed Consent Process: After the patient has been evaluated and meets all of the 
inclusion and exclusion criteria, a study team member besides Dr. Walter will introduce 
the study at the time of the subjects’ cataract evaluation or at the pre-operative work up. 
This typically will occur 1 to 8 weeks prior to surgery. The study will be discussed in 
detail and consent form (appendix 1) will be provided for the patient to review. Written 
informed consent will be obtained at either at the pre-op holding area or the week prior at 
the work up for surgery. Written informed consent will only be obtained once the patient 
has been given time to fully understand the study. If the patient agrees, patients will plan 
to forsake topical NSAIDs during the perioperative period and will agree to have Omidria 


infusion during cataract surgery. As per standard for cataract surgery, patients will return 
the following day, where the usual measurements will be taken including visual acuity, 
intraocular pressure, and measurement of anterior cell and flare. The subjects will also 
return for post op visits at 2 and 6 weeks, where in addition to the above measurements, 
the macular OCT will be obtained.  
• 
Study Procedure: The enrolled subjects will undergo standard topical 
phacoemulsification (with or without laser assistance) using Omidria, as labeled by the 
FDA, throughout the cataract surgery.  The Omidria will be provided at no cost to the 
patient nor the hospital, and will be provided by Omeros. The subjects will be monitored 
for any usual or atypical outcomes post-operatively. If the patients have atypical eye pain, 
anterior chamber cell greater than 2+, or macular thickening greater than 50 microns 
above baseline as documented via the OCT, the patients will be instructed to start a 
topical NSAID, like bromfenac, and will be used as per standard cataract surgery.   
 
Outcome Measures  
 
• Best corrected visual acuity at baseline (pre-op), 2 weeks and 6 weeks.  
• Presence of Cystoid Macular Edema at 2 weeks and 6 weeks 
• Macular thickness at baseline (pre-op), 2 weeks and 6 weeks 
• Need for a topical NSAID (rescue med) and reason 
• Anterior chamber cell and flare at 1 day, 2 weeks and 6 weeks.   
 
Analytical Plan 
 
Results will be analyzed initially using descriptive statistics where applicable.  This is not 
intended to be a comparative study but a utilization, efficacy and safety study. Results will 
be compared to historical controls with known outcomes in the general population 
undergoing routine cataract surgery. For example, a recent peer-reviewed paper with a 
large cohort where bromfenac was used in routine cataract showed an incidence of CME at 
3.6%9. Dr. Walter, with unpublished data using Omidria on routine cataract surgery, has 
noted a low incidence of CME at less than 0.5%. We are hoping to show that the use of 
Omidria is accounting for this reduced rate of CME and macular thickening.  
 
Human Subjects Protection 
  
Subject Recruitment Methods 
 
Subjects will be recruited though direct asking at the time of scheduling their cataract surgery. 
Patients who decline to participate will be treated exactly the same during and after surgery as 
those that consent to participate.  Participants will be not compensated directly but will likely 
benefit from not having to pay a co-pay on the normally used topical NSAID. Because of the 
potential conflict of interest with Omeros, Dr. Walter will not participate in recruiting nor during 
the consenting process. Dr. Mathew Giegengack will be the medical safety monitor and will 
review charts and insure no patients were inappropriately recruited or consented. 
 
Informed Consent  
 
Signed informed consent will be obtained from each subject. The study will be introduced by the 
study coordinator and informed consent will be obtained formally by a study team member once 


the patient fully understands the study. Informed consent will be given 1 or more weeks prior to 
the patient’s surgery, giving them plenty of time to decide and fully understand the study. Final 
written consent will be obtained by the day the surgery or at the pre-operative work up.  
 
Confidentiality and Privacy  
 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that 
could directly identify subjects, and maintaining all study information in a secure manner.  
To help ensure subject privacy and confidentiality, only a unique study identifier will 
appear on the data collection form.  Any collected patient identifying information 
corresponding to the unique study identifier will be maintained on a linkage file, store 
separately from the data.  The linkage file will be kept secure, with access limited to 
designated study personnel.  Following data collection subject identifying information will 
be destroyed 3 years after the study is published. They will be destroyed by deleting all files 
and shredding any documents consistent with data validation and study design, producing 
an anonymous analytical data set.  Data access will be limited to study staff.  Data and 
records will be kept locked and secured, with any computer data password protected.  No 
reference to any individual participant will appear in reports, presentations, or publications 
that may arise from the study. 
 
Data and Safety Monitoring  
 
Dr. Giegengack will be responsible for the overall monitoring of the data and safety of study 
participants.  The principal investigator will be assisted by other members of the study 
staff. The study will cease to enroll patients if the CME rate rises above 20%, or if more 
than half of the patients have atypical pain and/or inflammation requiring a topical NSAID. 
Greg Russell or a member of his team will help with statistical analysis as we begin data 
collection.  
 
Pregnancy in Female Patients 
 
Female patients of childbearing potential will be instructed to notify the investigator 
immediately (no more than 24 hours after learning of the pregnancy) if pregnancy occurs 
during the study. If pregnancy occurs, the patient will be withdrawn from the study, and 
the investigator will discuss the risk of pregnancy and the possible effects to the fetus. 
Monitoring of the pregnancy will occur until the conclusion of the pregnancy. 
 
 
Reporting of Unanticipated Problems, Adverse Events, or Deviations  
 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of 
the research team to the IRB and sponsor or appropriate government agency if 
appropriate. Dr. Giegengack has agreed to serve as an unbiased medical monitor.  
 
 
References. 


1) Yang J, et al. Risk factors for and diagnosis of pseudophakic 
cystoid macular edema after cataract surgery in diabetic 
patients. J Cataract Refract Surg. 2017 Feb;43(2):207-214. 
2) Wielders LH, et al. Prevention of Cystoid Macular Edema After 
Cataract Surgery in Nondiabetic and Diabetic Patients: A 
Systematic Review and Meta-Analysis. Am J Ophthalmol. 2015 
Nov;160(5):968-981 
3) Novack GD. Quality of generic ophthalmic drugs. Ocul Surf. 2013 
Jan;11(1):54-6. 
4) Kessel L, et al. Post-cataract prevention of inflammation and 
macular edema by steroid and nonsteroidal anti-inflammatory eye 
drops: a systematic review. Ophthalmology. 2014 Oct;121(10):1915-
24 
5) Henderson BA, et al. Clinical pseudophakic cystoid macular edema. 
Risk factors for development and duration after treatment. J 
Cataract Refract Surg. 2007 Sep;33(9):1550-8. 
6) Bucci FA Jr, Waterbury LD. Comparison of ketorolac 0.4% and 
bromfenac 0.09% at trough dosing: aqueous drug absorption and 
prostaglandin E2 levels. J Cataract Refract Surg. 2008 
Sep;34(9):1509-12. 
7) Waterbury LD. Alternative Drug Delivery for Patients Undergoing 
Cataract Surgery as Demonstrated in a Canine Model. J Ocul 
Pharmacol Ther. 2018 Jan/Feb;34(1-2):154-160 
8) Kim SJ, Flach AJ, Jampol LM. Nonsteroidal anti-inflammatory drugs 
in ophthalmology. Surv Ophthalmol. 2010 Mar-Apr;55(2):108-33 
9) Wielders LHP, et.al. European multicenter trial of the prevention 
of cystoid macular edema after cataract surgery in nondiabetics: 
ESCRS PREMED study report 1. J Cataract Refract Surg. 2018 
Apr;44(4):429-439 
 
 

ICF_000.pdf: 
Title:  The Effects of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular 
Edema in Cataract Surgery
Date: 12/14/2020
NCT03864133


Page 1 of 10
Adult Consent Form
Version: _____3________
IRB Template Version 2.17.16
Department/Section of Department of Ophthalmology 
No Drop Cataract Surgery: The effect of Intraocular Phenylephrine/Ketorolac Infusion on 
Retinal Thickness and Macular Edema in Cataract Surgery.
Informed Consent Form to Participate in Research
Keith Walter MD; Principal Investigator
INTRODUCTION
You are invited to be in a research study. Research studies are designed to gain scientific 
knowledge that may help you and/or other people in the future. You are being asked to take part 
in this study because you are scheduled to undergo cataract surgery for one eye or both eyes 
within 1- 4 weeks of each other most likely 2 weeks apart.  Your participation is voluntary. 
Please take your time in making your decision as to whether or not you wish to participate. Ask 
the study staff to explain any words or information contained in this informed consent document 
that you do not understand. You may also discuss the study with your friends and family.
WHY IS THIS STUDY BEING DONE?
The purpose of this research study is to test if we can eliminate the use of a post-operative eye 
drop. This would mean patients would no longer need to use any eye drops after cataract surgery. 
Over the last decade, we have reduced the number of drops needed from 3 prescriptions to just 
one anti-inflammatory drop, specifically a Non-Steroidal Anti-inflammatory Drug (NSAID). 
NSAIDS are drugs that help to control pain and inflammation. Issues with these drops include 
difficulty with placing the drops in the eye, using the drops as directed by the doctor, generic 
substitution and insurance coverage. A large number of patients aren’t able to afford these drops, 
or these drops aren’t covered by insurance. Pharmacists often substitute the prescribed drug for a 
generic version or a similar drug that does not work as well. Recently, Omidria (phenylephrine 
and ketorolac injection 1% / 0.3%) was approved by the Food and Drug Administration (FDA) 
for post-operative pain and inflammation in patients having cataract surgery. Omidria is a 
combination drug consisting of phenylephrine and ketorolac, and is used as an irrigating solution 
applied to the eye during cataract surgery. Ketorolac is a strong NSAID, and stops prostaglandins 
which cause pain, inflammation, and swelling. Animal studies have shown that Omidria can 
prevent prostaglandin production nearly 100% for over 12 hours post cataract surgery when 
given during surgery.  
In the study we will be using Omidria with the fluid used in “washing” out the cataract. Since 
Omidria was FDA approved for cataract surgery 3 years ago, we use it quite often to help with 
pain, inflammation and the added benefit of maintaining a dilated pupil during surgery which 
helps to prevent complications from cataract removal. We now wonder if the post-operative 
topical NSAID eye drop is even needed. We would like to eliminate as many unneeded drops as 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00050415
Meeting Date Approved 12/14/2020
Version Valid Until: 12/13/2021


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Adult Consent Form
Version: _____3________
IRB Template Version 2.17.16
possible. We will be monitoring you post op to determine the success of your surgery and to 
measure your pain, inflammation and any unexpected swelling. These measures are standard for 
cataract surgery patients, and will be done routinely as part of your follow up exams after your 
cataract removal surgery even if you do not choose to participate in the study. If needed you may 
be prescribed a NSAID drop if you develop pain, inflammation or unexpected swelling after 
your surgery.
You can elect to enroll one or both eyes if you wish. You can withdraw from the study at any 
time, even if the first eye was already done successfully.  
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
Up to 200 people will take part in this study.
WHAT IS INVOLVED IN THE STUDY?
If you agree to be in the research study you can choose to remain enrolled from the time of your 
first cataract surgery to about 6 weeks following your second cataract surgery which may be 
scheduled from 1 to 4 weeks (typically 2 weeks) after the first surgery. 
If you take part in this study, you will have the following tests and procedures:
Visit 1: Your first visit will be the clinic visit where you will be evaluated to see if you are 
eligible to be enrolled in the research study. If you meet all the criteria for the study, a study 
coordinator will discuss the study with you. You will be given plenty of time to review the 
consent and the opportunity to ask questions so you can make a decision on whether you would 
like to participate. This will likely be the same visit where you are evaluated for cataracts and 
determine to be eligible for cataract surgery. 
Visit 2: Day of your first cataract surgery. On this day you will undergo your scheduled cataract 
surgery on the first eye. You will be given Omidria during your cataract surgery at no cost to 
you.  This drug will be administered frequently to the eye to control the pupil size during cataract 
surgery and to control post-op pain. 
Visit 3: 18-24 hours post cataract surgery. This is a standard post op required visit. On this day, 
you will be asked to come into the clinic where all the standard tests will be conducted, such as 
pupil size measurement, and intraocular pressure will be measured. Your vision and comfort 
levels will also be evaluated at this time. This is standard testing we do for any patient whether in 
the study or not.
Visit 4: 1-2 weeks post-surgery. This is a standard post op visit. Your vision and comfort levels 
will also be evaluated at this time, as well as intraocular pressure and inflammation checked and 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00050415
Meeting Date Approved 12/14/2020
Version Valid Until: 12/13/2021


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Adult Consent Form
Version: _____3________
IRB Template Version 2.17.16
recorded. A macular scan will be performed to check if there is any swelling. 
Visit 5: 5-6 weeks post-surgery. This is also a standard post op visit. Your vision and comfort 
levels will also be checked at this time, as well as intraocular pressure and inflammation 
monitored and recorded. A macular scan will be performed to determine if there is any swelling. 
 
If you have decided to have both eyes enrolled in the study, the same procedures will be done for 
the second eye. If you decide to enroll both eyes some visits will likely be done at the same time. 
For example, if you have the second eye done 2 weeks after the first, then when study eye 1 will 
be at visit #3 (two weeks); study eye 2 will be at visit #2 (one day). This means that you won’t 
likely complete 10 visits if you enroll both eyes but only 6-8 total visits.  The total number of 
visits is the same whether you elect to participate in the study or not.
HOW LONG WILL I BE IN THE STUDY?
You will be in the study for from the time of your first cataract surgery to 6 weeks following 
your second cataract surgery which may be scheduled from 1 to 4 weeks after the first surgery. If 
you choose to only enroll one eye then you will be enrolled in this study from the time of the 
surgery for the eye enrolled in the study until 6 weeks after your surgery. 
You can stop participating at any time. If you decide to stop participating in the study we 
encourage you to talk to the study doctor or study staff first to learn about any potential health or 
safety consequences. You will likely need to be prescribed topical medication, and continue to 
do our normal post op visits.
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you. You should discuss the risk of being in this study 
with the study staff. Allergies to Omidria or NSAIDs would prevent you from participating in 
this study, so please let the study staff know if you have a rash or hives from prior NSAIDs. You 
may be allergic to Omidria or NSAIDs, and be unaware. Allergies can be a threat to your health, 
including death which is rare. Systemic exposure to phenylephrine, a part of Omidria, could 
cause your blood pressure to rise. Your blood pressure will be monitored during your surgery, 
and treated if needed. 
If you enroll, we do not plan on using any topical eye drops, such as NSAIDs or corticosteroids 
after your surgery. There may be complications or risks involved that can’t be predicted. Some 
of those risks may include:

Pain

tenderness

 light sensitivity
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00050415
Meeting Date Approved 12/14/2020
Version Valid Until: 12/13/2021


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Adult Consent Form
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
 Blurred vision from macular edema or swelling in the back of the eye
Common side effects of Omidria may include:

Inflammation inside your eye

Increased Intraocular Pressure

Posterior Capsule Opacification or a cloudiness behind the lens (seen in routine cataract 
surgery about 30% of the time and treatable in the office with a laser)

Eye Irritation

Foreign Body Sensation in Eyes or feeling as though something is in your eye
These risks are uncommon, but do occur with cataract surgery in general, and often occur even 
with topical drops are used. There is a small risk that you will still need these prescribed topical 
drugs, and that you will have to pay for them or use your insurance. All of these risks are 
treatable with additional drops or medications, or a laser treatment. Please discuss these risk and 
the treatment options with the study doctor.
There is a slight risk of a breach of confidentiality which is when your private information is 
disclosed without your consent.  We will do our best to protect your confidential information.  
There also may be other side effects that we cannot predict. You should tell the research staff 
about all the medications, vitamins and supplements you take and any medical conditions you 
have. This may help avoid side effects, interactions and other risks.
The risk of harm or discomfort that may happen as a result of taking part in this research study is 
not expected to be more than in daily life or from routine physical or psychological examinations 
or tests.  You should discuss the risk of being in this study with the study staff.
Taking part in this research study may involve providing information that you consider 
confidential or private.  Efforts, such as coding research records, keeping research records secure 
and allowing only authorized people to have access to research records, will be made to keep 
your information safe.
Reproductive Risks and other Issues to Participating in Research
Due to unknown risks and potential harm to the unborn fetus, sexually active women of 
childbearing potential must use a reliable method of birth control while participating in this 
study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, 
intrauterine device (IUD), DepoProvera, tubal ligation, or vasectomy of the partner (with 
confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, 
although less reliable, method involves the careful use of condoms and spermicidal foam or gel 
and/or a cervical cap or sponge. We encourage you to discuss this issue further with your 
physicians if you have any questions.
Pregnant women are excluded from participation in this study. Because some methods of birth 
control are not 100% reliable, a pregnancy test is required at least 10 days from your last normal 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00050415
Meeting Date Approved 12/14/2020
Version Valid Until: 12/13/2021


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Adult Consent Form
Version: _____3________
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menstrual period, if you are a sexually active woman of childbearing potential.
Pregnant women are excluded from participation in this study. If you are a sexually active 
woman of childbearing potential and have not been using a reliable method of birth control, two 
negative pregnancy tests performed 15 days apart are required to check for possible early 
pregnancy prior to starting treatment.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
If you agree to take part in this study, there may or may not be direct benefit to you. 
. We hope the information learned from this study will benefit other people in the future. The 
benefits of participating in this study may be: eliminating the need for eye drops before and after 
surgery. This may save you money, time and hassle of placing frequent drops for the month after 
surgery. Omidria is FDA approved for maintaining an acceptable pupil size during cataract 
surgery. This may make the surgery easier and faster for you and the surgeon. 
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study to receive treatment. You should talk to the study team 
members about all the choices you have. Instead of being in this study, you have these options:

Use the routine eye drop, bromfenac, obtained from the pharmacy, starting 2 days before 
and continuing for at least 4 weeks after surgery. 
WHAT ARE THE COSTS?
All study costs, including any study medications and procedures related directly to the study, will 
be paid for by the study. Costs for your regular medical care, such as the cataract surgery itself, 
the use of the laser, or a premium lens, which are not related to this study, will be your own 
responsibility. We will not bill you nor your insurance company for the additional post op visit, 
but your insurance will be billed for the cataract surgery as we would any non-study patient. 
The cost of the Omidria will be covered by the study. You or your insurance company will not 
be billed for the Omidria used for the purposes of this study.. Any additional tests, will not be 
charged, and are part of the routine post-operative care we provide any patient undergoing 
cataract surgery. 
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical meetings or published 
in scientific journals. Your identity and/or your personal health information will not be disclosed 
except as authorized by you or as required by law. However, there is always some risk that even 
de-identified information might be re-identified. 
Participant information may be provided to Federal and other regulatory agencies as required.  
The Food and Drug Administration (FDA), for example, may inspect research records and learn 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00050415
Meeting Date Approved 12/14/2020
Version Valid Until: 12/13/2021


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Adult Consent Form
Version: _____3________
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your identity if this study falls within its jurisdiction.
WILL YOU BE PAID FOR PARTICIPATING?
You will receive no payment or other compensation for taking part in this study.
WHO IS SPONSORING THIS STUDY?
This study is being sponsored by Dr. Keith Walter and the Department of Ophthalmology. In 
addition, Omeros will be providing the drug at no cost.  
Dr. Walter has a relationship with Omeros and receives income, separate from this study, for 
consulting and speaking services for Omeros. Dr. Walter will not receive any additional income 
from Omeros for participating in this study. 
What Happens if You Experience an Injury or Illness as a Result of 
Participating in this Study?
Should you experience a physical injury or illness as a direct result of your participation in this 
study, Wake Forest University School of Medicine maintains limited research insurance 
coverage for the usual and customary medical fees for reasonable and necessary treatment of 
such injuries or illnesses. To the extent research insurance coverage is available under this policy 
the reasonable costs of these necessary medical services will be paid, up to a maximum of 
$25,000. Wake Forest University Baptist Medical Center holds the insurance policy for this 
coverage. It provides a maximum of $25,000 coverage for each claim and is limited to a total of 
$250,000 for all claims in any one year. The Wake Forest University School of Medicine, and 
the North Carolina Baptist Hospitals, Incorporated do not assume responsibility to pay for these 
medical services or to provide any other compensation for such injury or illness. Additional 
information may be obtained from the Medical Center’s Director of Risk and Insurance 
Management, at 
.
WHAT ABOUT MY HEALTH INFORMATION?
In this research study, any new information we collect from you and/or information we get from 
your medical records about your health or behaviors is considered Protected Health Information. 
The information we will collect for this research study includes: patient name, age, gender, 
patient MRN, date of birth, gender, race, visual acuity, eye pressure, date of surgery, eye(s) 
involved, complications, pain scores, inflammation scores, macular thickness by OCT. , pupil 
sizes, eye color, intraocular pressure, and photo of your eyes 
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study will be placed in your medical record, 
and may be used to help treat you, arrange payment for your care, or assist with Medical Center 
operations. 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00050415
Meeting Date Approved 12/14/2020
Version Valid Until: 12/13/2021


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Adult Consent Form
Version: _____3________
IRB Template Version 2.17.16
Laboratory test results and other medical reports created as a result of your participating in the 
research study may be entered into the computer systems of Wake Forest University Health 
Sciences and North Carolina Baptist Hospital. These will be kept secure, with access to this 
information limited to individuals with proper authority, but who may not be directly involved 
with the research study.
A North Carolina Baptist Hospital (NCBH) medical record will be created for all study 
participants. Information about your participation in the study will be placed in the NCBH 
medical record, along with any routine medical test results that were obtained at NCBH as part 
of this study.
If you choose to participate in this study, your medical record at Wake Forest University Medical 
Center will indicate that you are enrolled in a clinical trial. Information about the research and 
any medications or devices you are being given as a participant may also be included in your 
medical record. This part of the medical record will only be available to people who have 
authorized access to your medical record. If you are not a patient at this Medical Center, a 
medical record will be created for you anyway to ensure that this important information is 
available to doctors in case of an emergency. 
We will make every effort to keep your Protected Health Information private. We will store 
records of your Protected Health Information in a cabinet in a locked office or on a password 
protected computer. 
Your personal health information and information that identifies you (“your health information”) 
may be given to others during and after the study. This is for reasons such as to carry out the 
study, to determine the results of the study, to make sure the study is being done correctly, to 
provide required reports and to get approval for new products.  
Some of the people, agencies and businesses that may receive and use your health information 
are the research sponsor; representatives of the sponsor assisting with the research; investigators 
at other sites who are assisting with the research; central laboratories, reading centers or analysis 
centers; the Institutional Review Board; representatives of Wake Forest University Health 
Sciences and North Carolina Baptist Hospital; representatives from government agencies such as 
the Food and Drug Administration (FDA), the Department of Health and Human Services 
(DHHS) and similar agencies in other countries.
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations.  Your health information may be disclosed if required by law. Your health 
information may be used to create information that does not directly identify you. This 
information may be used by other researchers. You will not be directly identified in any 
publication or presentation that may result from this study unless there are photographs or 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00050415
Meeting Date Approved 12/14/2020
Version Valid Until: 12/13/2021


Page 8 of 10
Adult Consent Form
Version: _____3________
IRB Template Version 2.17.16
recorded media which are identifiable.
If required by law or court order, we might also have to share your Protected Health Information 
with a judge, law enforcement officer, government agencies, or others. If your Protected Health 
Information is shared with any of these groups it may no longer be protected by federal or state 
privacy rules.
Any Protected Health Information collected from you in this study that is maintained in the 
research records will be kept for at least six years after the study is finished. At that time any 
research information not already in your medical record will either be destroyed or it will be de-
identified. You will not be able to obtain a copy of your Protected Health Information in the 
research records until all activities in the study are completely finished. 
You can tell Dr. Keith Walter MD that you want to take away your permission to use and share 
your Protected Health Information at any time by sending a letter to this address:
Keith Walter MD
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
By signing this form you give us permission to use your Protected Health Information for this 
study.
A description of this clinical trial 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 Web site at any time.
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT?
Taking part in this study is voluntary. You may choose not to take part or you may leave the 
study at any time. Refusing to participate or leaving the study will not result in any penalty or 
loss of benefits to which you are entitled. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. The investigators also have the right to stop your participation in the study 
at any time. This could be because you need additional medication to control pain, inflammation 
or macular swelling. Additionally, if you fail to make the post op visits or are unable to 
participate in testing. 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00050415
Meeting Date Approved 12/14/2020
Version Valid Until: 12/13/2021


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Adult Consent Form
Version: _____3________
IRB Template Version 2.17.16
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study 
investigator, Dr. Keith Walter MD at 
.
The Institutional Review Board (IRB) is a group of people who review the research to protect 
your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions or want to offer input, or you want to obtain 
additional information, you should contact the Chairman of the IRB at 
You will be given a copy of this signed consent form. 
SIGNATURES
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form.  If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me.  I have had a chance to 
ask questions about being in this study and have those questions answered.   By signing this 
consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution or its agents from liability for negligence.
I consent to a) one eye (right or left) 
                          OR
                 b) both eyes
Subject Name (Printed):_____________________________
Subject Signature:________________________________Date:________Time________am pm
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent: ___________________________ Date:_________ Time:________ am pm
Circle One
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00050415
Meeting Date Approved 12/14/2020
Version Valid Until: 12/13/2021


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Adult Consent Form
Version: _____3________
IRB Template Version 2.17.16
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00050415
Meeting Date Approved 12/14/2020
Version Valid Until: 12/13/2021