Outcomes Comparison Between Baerveldt 350 and Ahmed ClearPath 250 Tube Shunts for the Treatment of Glaucoma
Phase: NA
Conditions: Glaucoma
Sponsor: State University of New York at Buffalo

 
Page 1 of 38 
 
Cover Page for Protocol, Statistical Plan and ICF 
 
Official Title: 
Outcomes Comparison Between Baerveldt 350 and 
Ahmed ClearPath 250 Tube Shunts for the Treatment 
of Glaucoma 
NCT number: 
NCT04542616 
Document Type: 
Study Protocol 
Date of the 
Document: 
08/12/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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IRB Version: 5/6/19 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Cover Page for Protocol, Statistical Plan and ICF ............................................ 1 
Template Instructions ....................................................................................................... 3 
1.0 
Study Summary ....................................................................................................... 5 
2.0 
Objectives* ............................................................................................................. 6 
3.0 
Scientific Endpoints* .............................................................................................. 6 
4.0 
Background* ........................................................................................................... 6 
5.0 
Study Design* ......................................................................................................... 8 
6.0 
Study Intervention/Investigational Agent ............................................................... 8 
7.0 
Local Number of Subjects .................................................................................... 10 
8.0 
Inclusion and Exclusion Criteria* ......................................................................... 11 
9.0 
Vulnerable Populations* ....................................................................................... 12 
10.0 
Eligibility Screening* ........................................................................................... 14 
11.0 
Recruitment Methods ............................................................................................ 14 
12.0 
Procedures Involved* ............................................................................................ 15 
13.0 
Study Timelines* .................................................................................................. 18 
14.0 
Setting ................................................................................................................... 18 
15.0 
Community-Based Participatory Research ........................................................... 19 
16.0 
Resources and Qualifications ................................................................................ 20 
17.0 
Other Approvals .................................................................................................... 21 
18.0 
Provisions to Protect the Privacy Interests of Subjects ......................................... 21 
19.0 
Data Management and Analysis* ......................................................................... 22 
20.0 
Confidentiality* .................................................................................................... 23 
A. 
Confidentiality of Study Data ............................................................................ 23 
B. 
Confidentiality of Study Specimens .................................................................. 24 
21.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects* ....................... 25 
22.0 
Withdrawal of Subjects* ....................................................................................... 27 
23.0 
Risks to Subjects* ................................................................................................. 27 
24.0 
Potential Benefits to Subjects* ............................................................................. 29 
25.0 
Compensation for Research-Related Injury .......................................................... 29 
26.0 
Economic Burden to Subjects ............................................................................... 30 
27.0 
Compensation for Participation ............................................................................ 30 
28.0 
Consent Process .................................................................................................... 30 
29.0 
Waiver or Alteration of Consent Process .............................................................. 35 
30.0 
Process to Document Consent .............................................................................. 36 
31.0 
Multi-Site Research (Multisite/Multicenter Only)* .............................................. 36 
32.0 
Banking Data or Specimens for Future Use* ....................................................... 38 
 
 
 

 
Page 3 of 38 
IRB Version: 5/6/19 
Template Instructions 
Sections that do not apply: 
• In several sections, the addition of checkboxes for Not Applicable have been 
added to the template as responses.   
o If an N/A checkbox is present, select the appropriate justification 
from the list.   
o If an N/A checkbox is not present, or if none of the existing 
checkboxes apply to your study, you must write in your own 
justification. 
• In addition: 
o For research where the only study procedures are records/chart 
review:  Sections 6, 21, 22, 24, 25, 26 and 27 do not apply. 
o For exempt research:  Section 6 may not apply. Section 6.1 will 
still apply if there is a study intervention. 
 
Studies with multiple participant groups: 
 
• If this study involves multiple participant groups (e.g. parents and children), 
provide information in applicable sections for each participant group. Clearly 
label responses when they differ.  For example: 
Response Example 
Intervention Group:  
Control Group: 
Formatting: 
• Do not remove template instructions or section headings when they do not apply 
to your study. 
If you are pasting information from other documents using the “Merge Formatting” 
Paste option will maintain the formatting of the response boxes. 
Amendments: 
• When making modifications or revisions to this and other documents, use the 
Track Changes function in Microsoft Word. 
• Update the version date or number on Page 3. 
 
 

 
Page 4 of 38 
IRB Version: 5/6/19 
PROTOCOL TITLE: 
Include the full protocol title. 
Response:  
Outcomes comparison between Baerveldt 350 and Ahmed ClearPath 250 tube 
shunts for the treatment of glaucoma 
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Asher Weiner, MD 
Department of Ophthalmology/Ross Eye Institute 
(716) 881 7900 
aweiner7@gmail.com 
 
VERSION NUMBER/DATE: 
Include the version number and date of this protocol. 
Response:  
Version 1: 12Aug2020 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
FUNDING: 
Indicate any funding for this proposal. This should match the Funding Sources 
page in Click IRB. 
Response:  
This study is not funded 

 
Page 5 of 38 
IRB Version: 5/6/19 
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  
For a grant with multiple aims, indicate which aims are covered by this research 
proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response:  
Protocol is not funded by a grant 
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been 
closed.  The repository should include, at minimum, copies of IRB 
correspondence (approval, determination letters) as well as signed consent 
documents.  This documentation should be maintained for 3 years after the study 
has been closed.   
Response:  
Location: Ross Eye Institute 
Address: 1176 Main Street, Buffalo, NY, 14209 
Department: Department of Ophthalmology 
1.0 Study Summary 
 
Study Title 
Outcomes comparison between the Baerveldt 350 
and Ahmed ClearPath 250 tube shunts for the 
treatment of glaucoma 
Study Design 
Prospective randomized clinical trial 
Primary Objective 
To compare will compare the safety and efficacy of 
Baerveldt 350 and Ahmed ClearPath 250 tube shunts in 
lowering Intraocular pressure (IOP). 
Secondary 
Objective(s) 
N/A  
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Standard of care tube shunt implantation; comparison 
between two types of FDA-approved, commercially 
available, commonly used glaucoma tube shunts. 
IND/IDE #  
N/A  
Study Population 
Patients from the Ross Eye Institute glaucoma clinic 
Sample Size 
70 eyes of 70 patients 
Study Duration for 
individual 
participants 
24 months 

 
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IRB Version: 5/6/19 
Study Specific 
Abbreviations/ 
Definitions  
Intraocular pressure (IOP) 
2.0 Objectives* 
2.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  
We will compare the safety and efficacy of Baerveldt 350 and Ahmed ClearPath 
250 tube shunts in lowering IOP in glaucoma patients. 
2.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to 
happen in your study that corresponds with your above listed objectives. 
Response: 
We hypothesize that the ClearPath 250 tube shunt is as effective as 
Baerveldt 350 in IOP reduction despite the difference in plate size (250 vs. 
350 mm2), and as safe with a similar rate of post-operative complications. 
3.0 Scientific Endpoints* 
 
3.1    Describe the scientific endpoint(s), the main result or occurrence under 
study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine 
whether the objectives of the study have been met and to draw conclusions from the data.  
Include primary and secondary endpoints.  Some example endpoints are:  reduction of 
symptoms, improvement in quality of life, or survival.  Your response should not be a 
date.   
Response: 
Primary endpoint is postoperative IOP with a reduction of ≥20% from 
baseline and IOP ranging between 6-21 mmHg. 
Secondary endpoints are reduced need for glaucoma medications, and 
postoperative complications including corneal edema, iritis, hyphema, hypotony, 
vitreous hemorrhage, cystoid macular edema, vision loss and others.  
4.0 Background* 
4.1 Provide the scientific or scholarly background, rationale, and significance 
of the research based on the existing literature and how it will contribute to 
existing knowledge.  Describe any gaps in current knowledge.  Include 
relevant preliminary findings or prior research by the investigator.  
Response:  
Tube shunt implantation is a common type of surgery considered standard of care 
for treating significant potentially-blinding glaucoma where medical and laser 
treatment, and previous surgeries, have failed to control IOP sufficiently to stop 
glaucoma progression towards blindness. 

 
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Since a larger plate tube (e.g., Baerveldt 350) is more difficult to implant 
requiring longer surgical time and intraoperative ocular muscle manipulation with 
possible patient discomfort, a smaller plate tube shunt (e.g., Ahmed ClearPath 
250) requiring shorter surgical time and no ocular muscle manipulation may have 
an advantage if the long term surgical outcomes were the same. 
However, the literature is lacking regarding the effect of the tube plate size on the 
final outcomes of tube shunt implantation. Most published comparisons are 
between totally different types of tube shunts regardless of plate size, often made 
of different materials,1,2 often comparing valved vs. non-valved tube shunts,3-5 
combining different plate sizes in the same study groups,5 mixing tubes with or 
without combined cataract surgery in the same study groups,5 or comparing 
surgeries performed by several surgeons utilizing different surgical methods.1-5 
Further, all these studies utilize tubes implanted into the anterior chamber (AC) 
thus increasing the risk of corneal failure, with no comparisons al all between tube 
shunts implanted through the ciliary sulcus of the eye designed to reduce the risk 
of corneal failure. Our Principle Investigator (AW) is specializing and well-
published in this type of tube shunt implantation.6-8 
This prospective randomized trial is designed to resolve all these confusing 
factors in the literature and finally provide the answer of whether tube plate size 
has an effect on the final outcomes of tube shunt implantation by performing a 
"clean" study that would isolate the effect of tube plate size on long term 
outcomes. To achieve this goal our study will utilize two non-valved tube shunts 
with a different plate size (350 vs. 250 mm2) made of identical materials, in eyes 
that have already had cataract surgery, and all performed by the same surgeon 
(AW) through the ciliary sulcus. 
4.2 Include complete citations or references.  
Response: 
Pandav SS, Seth NG, Thattaruthody F, Kaur M, Akella M, Vats A, 
Kaushik S. Long-term outcome of low-cost glaucoma drainage device 
(Aurolab aqueous drainage implant) compared with Ahmed glaucoma 
valve. Br J Ophthalmol 2020;104:557–562. doi:10.1136/bjophthalmol-
2019-313942 
2. Hafeezullah N, AlHilali S, Alghulaydhawi F, Edward DP, Ahmad S, 
Malik R. A preliminary comparison of the Aravind aurolab drainage 
implant with the Baerveldt glaucoma implant: A matched case-control 
study. European Journal of Ophthalmology 
2020;https://doi.org/10.1177/1120672120912383 
3. Budenz DL, Barton K, Gedde SJ, Feuer WJ, Schiffman J, Costa VP, 
Godfrey DG, Buys YM. Five-Year Treatment Outcomes in the Ahmed 
Baerveldt Comparison Study. Ophthalmology 2015;122:308-316. 
https://doi.org/10.1016/j.ophtha.2014.08.043. 
4. Tsai JC, Johnson CC, Kammer JA, Dietrich MS. The Ahmed Shunt 
versus the Baerveldt Shunt for Refractory Glaucoma II: Longer-term 

 
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Outcomes from a Single Surgeon. Ophthalmology 2006;113:913-917. 
https://doi.org/10.1016/j.ophtha.2006.02.029. 
5. Dixon MW, Moulin TA, Margolis MS, Palko JR, Mortensen P, Conner 
IP, Sheybani A. Comparative Outcomes of the Molteno3 and Baerveldt 
Glaucoma Implants. Ophthalmology Glaucoma 2020;3:40-50. 
https://doi.org/10.1016/j.ogla.2019.10.003. 
6. Weiner A, Cohn AD†, Balasubramaniam M, Weiner AJ. Glaucoma tube 
shunt implantation through the ciliary sulcus in pseudophakic eyes with 
high risk of corneal decompensation J Glaucoma. 2010;19:405-411. 
PMID: 19907341. 
7. Weiner Y, Faridi O†, Weiner A. Clinical experience with sulcus-
implanted Baerveldt glaucoma tube shunts fully concealed behind the iris 
in undilated pseudophakic eyes J Glaucoma. 2013;22:667-671. PMID: 
23787336 
8. Weiner AJ, Weiner Y, Severson ML, Weiner A•. (March) Clinical 
experience with urgent tube shunt implantation through the ciliary sulcus 
in phakic eyes. Int Ophthalmol. 2019;39:639–649. 
https://doi.org/10.1007/s10792-018-0863-9. PMID: 29426968 
 
5.0 Study Design* 
5.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response:  
This is a prospective randomized interventional clinical study. Only 
patients requiring tube shunt implantation as their next standard-of-care 
treatment for their significant uncontrolled glaucoma will be recruited as 
long as they meet the inclusion/exclusion criteria. However, the patients 
will be randomized as to which tube shunt will be implanted. More than 
one eye per patient may be included in the study.  
All patients with significant uncontrolled glaucoma will be recruited from 
the Ross Eye Institute, University at Buffalo glaucoma clinic. The patients 
will be screened to see if they meet the inclusion/exclusion criteria. 
Informed consent will be obtained from all candidates prior to 
participation in the study. All surgeries will be performed by the same 
surgeon (AW). IOP, IOP-lowering medications and visual acuity and all 
standard glaucoma parameters will be measured preoperatively and during 
follow up visits. All intra and post-operative complications such as 
hypotony, corneal edema, hyphema and posterior segment complications 
will be recorded. 
 
6.0 
Study Intervention/Investigational Agent 

 
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6.1  
Describe the study intervention and/or investigational agent (e.g., 
drug, device) that is being evaluated. 
Response:  
Comparison between Baerveldt 350 tube shunt (Advanced Medical 
Optics, Santa Ana, CA) and Ahmed ClearPath 250 tube shunt (New World 
Medical, Rancho Cucamonga, CA). 
6.2 
Drug/Device Handling: If the research involves drugs or 
device, describe your plans to store, handle, and administer those 
drugs or devices so that they will be used only on subjects and be 
used only by authorized investigators. 
• 
If the control of the drugs or devices used in this protocol will 
be accomplished by following an established, approved 
organizational SOP (e.g., Research Pharmacy SOP for the 
Control of Investigational Drugs, etc.), please reference that 
SOP in this section. 
Response:  
One of the two tube shunts will be implanted in an ambulatory surgery center 
(ASC) as done routinely, and only in patients that require tube shunt implantation 
as their standard-of-care for their uncontrolled glaucoma. Both tubes are FDA-
approved and commercially available and the ASC will order the tubes from the 
corresponding companies as done routinely. The tube shunts will be implanted as 
usual by Dr. Asher Weiner who is an experienced glaucoma surgeon who has 
implanted many of these two devices as part of his routine glaucoma practice. 
None of the devices or procedures is experimental. 
 
6.3 If the drug is investigational (has an IND) or the device has an IDE 
or a claim of abbreviated IDE (non-significant risk device), include 
the following information: 
• 
Identify the holder of the IND/IDE/Abbreviated IDE. 
• 
Explain procedures followed to comply with sponsor 
requirements for FDA regulated research for the following: 

 
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IRB Version: 5/6/19 
 
Applicable to: 
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated 
IDE studies 
21 CFR 11 
X 
X 
 
21 CFR 54 
X 
X 
 
21 CFR 210 
X 
 
 
21 CFR 211 
X 
 
 
21 CFR 312 
X 
 
 
21 CFR 812 
 
X 
X 
21 CFR 820 
 
X 
 
Response: N/A 
 
7.0 Local Number of Subjects 
7.1 Indicate the total number of subjects that will be enrolled or records that 
will be reviewed locally. 
Response:  
70 subjects (70 eyes) will be recruited. The minimum "n" required based on the 
UB statistician’s recommendation is 24 patients in each of the two groups to a 
total of 48 patients, and we're adding a safety margin expecting that some patients 
will fail to return for follow-up during the full length of the study due to illness, 
death, noncompliance, moving away, etc. 
 
7.2 If applicable, indicate how many subjects you expect to screen to reach your 
target sample (i.e. your screen failure rate).  
Response:  
All patients will be recruited from the glaucoma clinic of the Ross Eye Institute. 
Only patients that require tube shunt implantation based on the clinical course of 
their disease and the mutual decision of the surgeon and patient, and meet the 
inclusion and exclusion criteria will be offered to participate in this study. 
 
7.3 Justify the feasibility of recruiting the proposed number of eligible subjects 
within the anticipated recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit? 
Response:  
The glaucoma clinic of the Ross Eye Institute is caring for large numbers of 
patients with severe glaucoma, the typical population that requires tube shunt 
implantation. Since the principle investigator’s practice focuses on the care of 
patients with significant glaucoma, a large portion of the patients in this practice 
are expected to be good candidates for tube shunt implantation. 

 
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8.0 Inclusion and Exclusion Criteria* 
8.1 Describe the criteria that define who will be included in your final study 
sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  
Inclusion criteria: 
1. Significant uncontrolled glaucoma despite medical, laser or previous surgical 
therapy that requires tube shunt implantation as standard-of-care to stabilize the 
glaucoma and preserve vision. 
2. Pseudophakia 
3. Patients who are willing to participate and are able to understand and sign the 
study consent form. 
4. Age ≥18 years. 
 
8.2 Describe the criteria that define who will be excluded from your final study 
sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
1. Phakic eyes (no previous cataract surgery). 
2. Age <18 years. 
3. Women of child-bearing age. 
4. Patients unable to comprehend and sign the study consent form. 
5. Patients without or with well-controlled glaucoma. 
6. Women who are pregnant. 
 
8.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in 
your study unless you indicate this in your inclusion criteria. 
Response:  None of these vulnerable populations will be used for this study  
☒ 
Adults unable to consent 
☒ 
Individuals who are not yet adults (infants, children, teenagers) 
☒ 
Pregnant women 

 
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☒ 
Prisoners 
 
8.4 Indicate whether you will include non-English speaking individuals in your 
study.  Provide justification if you will exclude non-English speaking 
individuals.  
In order to meet one of the primary ethical principles of equitable selection 
of subjects, non-English speaking individuals may not be routinely excluded 
from research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to 
investigate areas that would necessarily require certain populations who 
may not speak English, the researcher is required to make efforts to recruit 
and include non-English speaking individuals.  However, there are studies 
in which it would be reasonable to limit subjects to those who speak 
English.  Some examples include pilot studies, small unfunded studies with 
validated instruments not available in other languages, studies with 
numerous questionnaires, and some non-therapeutic studies which offer no 
direct benefit. 
Response:  
We would not include non-English speaking individuals for the following 
reasons: 
The majority of the Principal Investigator’s patients are English-speaking and we 
will be able to easily reach the targeted sample size in this population.  
Understanding the study risks, outcomes and benefits is paramount and dependent 
on any candidate’s linguistic skills. As this is an unfunded study, there are no 
resources available to hire a translation service to produce all of the necessary 
study documents in other languages, in the unlikely event that we encounter an 
eligible non-English speaker.  
Additionally, the procedures used in this study are considered Standard of Care 
and are available to any non-English speaking patient as part of their regular 
treatment. Excluding non-English speakers will not inequitably withhold any 
benefit from them. These non-English speakers, as well as anyone else excluded 
for any reason, or is unwilling to participate in this study, will still receive the 
surgery they need as Standard of Care regardless of their participation in this 
study. 
9.0 Vulnerable Populations* 
If the research involves special populations that are considered vulnerable, 
describe the safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you 
have provided adequate detail regarding safeguards and protections. You do not, 
however, need to provide these checklists to the IRB. 

 
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9.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
It is relatively rare to have patients at a child-bearing age needing glaucoma 
surgery in our practice due to age.  As a safety measure, we plan to exclude any 
woman who can or might be pregnant any time throughout the study. Women will 
be asked when their last menstrual period was to determine if they are of child 
bearing potential. To that end, we find it insufficient to test a candidate for 
pregnancy before the study since pregnancy may occur any time during our study 
two-year follow-up. 
 
☒ 
N/A:  This research does not involve pregnant women. 
9.2 For research that involves neonates of uncertain viability or non-viable 
neonates, safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
 
☒ 
N/A:  This research does not involve non-viable neonates or neonates of 
uncertain viability. 
9.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
 
☒ 
N/A:  This research does not involve prisoners. 
9.4 For research that involves persons who have not attained the legal age for 
consent to treatments or procedures involved in the research (“children”), 
safeguards include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
 
☒ 
N/A:  This research does not involve persons who have not attained the 
legal age for consent to treatments or procedures (“children”). 
9.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
 
☒ 
N/A:  This research does not involve cognitively impaired adults. 

 
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9.6 Consider if other specifically targeted populations such as students, 
employees of a specific firm, or educationally or economically 
disadvantaged persons are vulnerable.  Provide information regarding 
their safeguards and protections, including safeguards to eliminate 
coercion or undue influence. 
Response:  
This research will not target any vulnerable populations 
10.0 
Eligibility Screening* 
10.1 Describe screening procedures for determining subjects’ eligibility.  
Screening refers to determining if prospective participants meet inclusion and 
exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response: 
As part of routine clinical care, the principal investigator will perform clinical 
examination on new and follow up patients presenting to the Ross Eye Institute 
glaucoma service during the study recruitment period. 
After a detailed eye examination and comparison with previous visits results, if 
significant glaucoma is diagnosed or confirmed and is not properly controlled, 
and if the next most appropriate therapeutic step per standard-of-care is to proceed 
with tube shunt implantation with the goal of stabilizing the glaucoma and 
preventing further vision loss, the principal investigator will discuss the next 
treatment options with the patients. 
Once a mutual (surgeon and patient) decision is made to proceed with tube shunt 
implantation, the surgeon (principal investigator) will evaluate the clinical patient 
data to determine if the patient meets the inclusion and exclusion criteria. If so, 
the principal investigator will explain the surgical procedure, clinical outcome and 
informed consent process to the patients in detail. The patients will then be given 
an opportunity to read the informed consent form and make their decision whether 
to participate in the study. 
Patients who decline to participate in the study will still be treated in the exact 
same manner, including tube shunt implantation, as we follow routine clinical 
practice standard-of-care. 
All patients regardless of study participation will be contacted by the surgical 
coordinator to schedule their surgery. 
 
☐ 
N/A:  There is no screening as part of this protocol. 
11.0 
Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be 
recruited.  NOTE:  If you select this option, please make sure that 

 
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all records review procedures and inclusion/exclusion screening 
are adequately described in other sections. 
11.1 Describe when, where, and how potential subjects will be recruited.  
NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. 
searching charts for specific ICD code numbers, Research Participant Groups, 
posted advertisements, etc.). 
Response:  
Once a patient has been determined eligible to participate in this study, the 
principle investigator will approach the patient one-on-one in the glaucoma clinic 
at the Ross Eye Institute and explain the study. Participants will be given 
sufficient time to reply verbally to the one-on-one communication after being 
provided with the relevant study information and having any questions answered 
by the principal investigator. The consent process will follow once the participant 
affirmatively agrees to participate in the study 
 
11.2 Describe how you will protect the privacy interests of prospective subjects 
during the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself.   
Response:  
Every care will be taken to ensure that the recruitment procedures are conducted 
only in a private clinical workroom setting and only in the presence of the 
principal investigator, study coordinator and those authorized by the patient. 
 
11.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final 
audio/video tape.  NOTE:  You may submit the wording of the advertisement prior 
to taping to ensure there will be no IRB-required revisions, provided the IRB also 
reviews and approves the final version. 
 Response:  
All subjects will be recruited during the usual course of their regularly scheduled 
standard-of-care appointments at Ross Eye Institute. 
 
12.0 
Procedures Involved* 

 
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12.1 Provide a description of all research procedures or activities being 
performed and when they are performed once a subject is screened and 
determined to be eligible. Provide as much detail as possible.   
NOTE:  This should serve as a blueprint for your study and include enough detail 
so that another investigator could pick up your protocol and replicate the research.  
For studies that have multiple or complex visits or procedures, consider the 
addition of a schedule of events table in in your response. 
Response:  
-The study will be explained to and discussed with eligible patients by the 
principal investigator  
-Inform consents will be obtained once the patients inform the principal 
investigator of their interest to participate in the study. 
- Pre and post-surgical follow up visits will be scheduled the same regardless of 
study participation. Visits will be scheduled for before, and day 1 after surgery, 
and continuously as needed over at least the following 24 months at the frequency 
determined by the glaucoma status and clinical course. 
- Patients vision, IOP, visual field testing, fundus photos, OCT measurements and 
any post-surgical complications will be noted at scheduled visits. 
- These measurements will be performed by trained ophthalmic assistants under 
the supervision of the principal Investigator. This is a standard-of-care process.  
- Pre-operative and post-operative data will be collected from the patients EMR 
and will be used for data analysis. 
- All the above mentioned steps are done as a part of standard-of-care, except: 
     a. the randomization process to decide if the patient receives the Baerveldt 350 
shunt or the ClearPath 250 shunt.  You will have a 1:1 chance of receiving either 
Baerveldt 350 or ClearPath 250. It will be similar to flipping a coin. Every other 
patient will received Baerveldt 350. 
     b. the final step where the research data is extracted from the patients' EMR 
and transferred into an Excel sheet at each follow up visit.  
- The extracted data will be statistically analyzed to illustrate the results and 
findings of the study 
- The data will be presented at conferences and publications with all the patient 
identifiers removed. 
 
12.2 Describe what data will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, 
consider the addition of a schedule or table in your response. 
Response:  

 
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Patient EMR/ID, Gender, Date of Birth, Age at Baseline, Race, Medical Hx, 
conditions, Eye, Pre-Op Diagnosis, Glaucoma stage, Procedure and Procedure 
date.  
Pre-Op Findings include: Intra Ocular Pressure (IOP), Max IOP, Visual Acuity 
(VA), number of Medications, Cup-Disc Ratio, Visual Field parameters, OCT 
global RNFL and GCC, Central Corneal Thickness, Axial Length, Anterior 
Chamber Depth, Refraction (Sph Eq). 
Post-Op Findings include: IOP, VA, number of medications, measured at least on 
Day1, Week1, 2,3 and Months 1, 3, 6, 12, 18 and 24. Cup to disc ratio and visual 
fields parameters measured at least at month 6, 12, 18 and 24. OCT RNFL and 
GCC will be collected post-op at year 1, year 2. 
Complications such as hypotony, corneal edema, hyphema, iritis, vit. hemorrhage 
and CME will be recorded. Additional information would include information 
about secondary procedures or surgery, and random notes.  
 
 
 
The relevant research data from the patients EMR will be entered into a 
spreadsheet excluding private information and identifiers. 
 
12.3 List any instruments or measurement tools used to collect data 
(e.g. questionnaire, interview guide, validated instrument, data collection 
form).   
 
Include copies of these documents with your submission. 
Response:  
Snellen/LogMAR Visual Acuity chart, Slit Lamp, Applanation Tonometer, 
Gonioscope, Visual Field Analyzer and Spectralis OCT Device. These 
instruments are generally used on all patients during their routine clinical visits. A 
data collection form will be submitted on “Click” along with the protocol. 
 
12.4 Describe any source records that will be used to collect data about subjects 
(e.g. school records, electronic medical records). 
Response:  
Electronic Medical Records, NexTech, HIPAA compliant used at the Ross Eye 
Institute, maintained by UBMD, will be used to collect the study data 
12.5 Indicate whether or not individual subject results, such as results of 
investigational diagnostic tests, genetic tests, or incidental findings will be 
shared with subjects or others (e.g., the subject’s primary care physician) 
and if so, describe how these will be shared. 
Response:  
No, nothing beyond routine care will be collected and shared with the subject  
 

 
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12.6 Indicate whether or not study results will be shared with subjects or others, 
and if so, describe how these will be shared. 
Response:  
We plan to share aggregate study results in peer reviewed journal articles and 
meeting presentations 
 
13.0 
Study Timelines* 
13.1 Describe the anticipated duration needed to enroll all study subjects. 
Response:  
2 years from the date of study approval. 
 
13.2 Describe the duration of an individual subject’s participation in the study. 
Include length of study visits, and overall study follow-up time. 
Response:  
Pre-op/surgery then postsurgical follow up visits on at least 1 day, week 1, 2 3, 
months1, 3 months, 6 months, 12 months, 18 months, and 24 months after 
surgery.  
 
13.3 Describe the estimated duration for the investigators to complete this study 
(i.e. all data is collected and all analyses have been completed). 
Response:  
The cumulative study enrollment and post-surgical observation follow-up would 
last between 4-5 years 
 
14.0 
Setting 
14.1 Describe all facilities/sites where you will be conducting research 
procedures.  Include a description of the security and privacy of the 
facilities (e.g. locked facility, limited access, privacy barriers).  Facility, 
department, and type of room are relevant.  Do not abbreviate facility 
names.   
NOTE:  Examples of acceptable response may be: “A classroom setting in the 
Department of Psychology equipped with a computer with relevant survey 
administration software,” “The angiogram suite at Buffalo General Medical 
Center, a fully accredited tertiary care institution within New York State with 
badge access,” or, “Community Center meeting hall.” 
Response:  

 
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The research procedures will be conducted in a clinical work room setting within 
the 3 offices of University at Buffalo Department of Ophthalmology, Ross Eye 
Institute  
1176 Main Street, Buffalo, NY 14209 
3580 Sheridan Dr, 150 Amherst, NY 14226 
301 Sterling Drive, Orchard Park, NY 14127       
The surgery is performed as usual at an ASC in West Seneca, NY.  
The work room setting has controlled access and includes a computer that has 
access to the EMR and that is secure and locked between each use. The patient 
data are stored on password-protected network computers as required by 
University at Buffalo. The data analysis will be carried out in private office of 
principal investigator or research coordinator or with a statistician. 
 
14.2 For research conducted outside of UB and its affiliates, describe: 
• Site-specific regulations or customs affecting the research 
• Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside 
UB, i.e. research conducted in the community, school-based research, 
international research, etc.  It is not referring to multi-site research.  UB affiliated 
institutions include Kaleida Health, ECMC, and Roswell Park Cancer Institute.   
Response:  
There are no site specific regulations or customs and no scientific or ethical 
review requirements beyond what is required by the organization 
 
☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
15.0 
Community-Based Participatory Research 
15.1 Describe involvement of the community in the design and conduct of the 
research.  
NOTE:  Community-Based Participatory Research (CBPR) is a collaborative 
approach to research that equitably involves all partners in the research process 
and recognizes the unique strengths that each brings.  CBPR begins with a 
research topic of importance to the community, has the aim of combining 
knowledge with action and achieving social change to improve health outcomes 
and eliminate health disparities. 
Response:  
 
☒ 
N/A:  This study does not utilize CBPR. 

 
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15.2 
Describe the composition and involvement of a community advisory 
board. 
Response:  
 
☒ 
N/A:  This study does not have a community advisory board. 
16.0 
Resources and Qualifications 
16.1 Describe the qualifications (e.g., education, training, experience, expertise, 
or certifications) of the Principal Investigator and staff to perform the 
research.  When applicable describe their knowledge of the local study sites, 
culture, and society.  Provide enough information to convince the IRB that 
you have qualified staff for the proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research 
assistant, co-investigator, or pharmacist), a change to that person will not usually 
require prior approval by the IRB, provided that the person meets the 
qualifications described to fulfill their roles. 
Response:  
Primary Investigator: Asher Weiner, MD: A Board-certified Ophthalmologist 
with sub-specialty in glaucoma, working at UBMD Ross Eye Institute, who has 
been performing glaucoma procedures including tube shunt implantation routinely 
for many years, and is the only surgeon for this study. 
Research Coordinator: Sharon Michalovic, CCRC (CITI/GCP certified and assist 
in patient recruitment, taking consent, data compiling)  
Resident: Tyler Junttila, MD will assist with data management, overseeing visit 
schedules and taking patients' consent. 
Statistician (for assistance in data analysis) 
 
Describe other resources available to conduct the research.  
16.2 Describe the time and effort that the Principal Investigator and research 
staff will devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours 
per week.  The question will elicit whether there are appropriate resources to 
conduct the research. 
Response:  
5-6 hours per week: may be more or less weekly depending on the extent of 
extracting information from the EMR, finding the patients that meet the eligibility 
criteria, number of surgeries scheduled during each week, and transferring the 
data into spread sheet for data analysis 
 

 
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16.3 Describe the availability of medical or psychological resources that subjects 
might need as a result of anticipated consequences of the human research, if 
applicable. 
NOTE:  One example includes: on-call availability of a counselor or psychologist 
for a study that screens subjects for depression. 
Response:  
The study is being conducted at Ross Eye Institute and arrangements with the 
principal investigator have been made to provide treatment for any post-surgical 
event or complications. The principle investigator will provide all surgical and 
post-surgical care as performed routinely, and he and other Ophthalmologists on-
call will be available 24/7, 365 days a year, to evaluate and treat all study subjects 
in case of an emergency 
 
16.4 Describe your process to ensure that all persons assisting with the research 
are adequately informed about the protocol, the research procedures, and 
their duties and functions. 
Response:  
All persons involved with the research will sit one-on-one with the primary 
investigator to discuss the background of the project, the IRB application, and the 
study protocol. There will also be built in time for questions, as well as freedom 
to ask questions at any time during their involvement in the project 
The ophthalmic technicians are extensively trained by the principal investigator to 
measure visual acuity and visual field tests. The intraocular pressure, slit lamp 
findings and cup disc ratio will be measured either by the principal investigator or 
a resident physician under the supervision of the principal investigator 
17.0 
Other Approvals 
17.1 Describe any approvals that will be obtained prior to commencing the 
research (e.g., school, external site, funding agency, laboratory, radiation 
safety, or biosafety). 
Response:  
☒ 
N/A:  This study does not require any other approvals. 
18.0 
Provisions to Protect the Privacy Interests of Subjects 
18.1 Describe how you will protect subjects’ privacy interests during the course 
of this research. 
NOTE:  Privacy refers to an individual’s right to control access to him or herself.  
Privacy applies to the person.  Confidentiality refers to how data collected about 
individuals for the research will be protected by the researcher from release.  
Confidentiality applies to the data.   
Examples of appropriate responses include: “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the 

 
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participant is reminded that they are free to refuse to answer any questions that 
they do not feel comfortable answering.”   
Response:  
Patients are informed during the consent process that they can voluntarily 
withdraw their participation from the research study without penalty or denial of 
any further care. Patients are reminded that they are free to refuse to answer any 
questions that they are not comfortable answering. Privacy is maintained all the 
time where the patient communicates with the principal investigator or research 
coordinator in a clinical work room setting that no one can over hear 
18.2 Indicate how the research team is permitted to access any sources of 
information about the subjects.   
NOTE:  Examples of appropriate responses include:  school permission for review 
of records, consent of the subject, HIPAA waiver.  This question does apply to 
records reviews. 
Response:  
The screening occurs during a patient’s regularly scheduled Standard-of-care 
(SOC) appointment and the principal investigator will evaluate the clinical patient 
data to determine if the patient meets the inclusion and exclusion criteria. Once 
the eligible patients have been identified and have indicated willingness to 
participate, the patients will provide their signed consent and HIPAA 
authorization for continued access to their EMR data for this study.  
19.0 
Data Management and Analysis* 
19.1 Describe the data analysis plan, including any statistical procedures.  This 
section applies to both quantitative and qualitative analysis.  
Response:  
Quantitative analysis of the data will be done using the built-in features of 
MicrosoftTM Excel or other software tools including T-test, Linear Regression, 
Kaplan-Meier survival analysis and Chi-Squared test. Further statistical analysis 
would involve a statistician. 
19.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records 
reviews, survey studies, or observational studies.  This question is asked to elicit 
whether the investigator has an adequate sample size to achieve the study 
objectives and justify a conclusion.  
Response:  
A power analysis was done and a sample size was determined by the Statistician 
at University at Buffalo. 70 subjects (70 eyes) will be recruited. The minimum "n" 
required based on the UB statistician’s recommendation is 24 patients (more than 
one eye per patient may be included) in each of the two groups to a total of 48 
patients, and we're adding a safety margin expecting that some patients will fail to 

 
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return for follow-up during the full length of the study due to illness, death, 
noncompliance, moving away, etc. 
 
 
19.3 Describe any procedures that will be used for quality control of collected 
data. 
Response:  
Visual acuity will be measured in a sufficient room illumination that is normally 
used in every clinical routine eye examination 
Measures are taken to make sure that the applanation tonometer instrument to 
measure intraocular pressure is calibrated once every two weeks  
The visual field tests and the optic nerve imaging will be conducted by a trained 
Ophthalmic Assistant 
 
20.0 
Confidentiality* 
 
A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data 
and any records that will be reviewed for data collection.   
 
20.1 
A.  Where and how will all data and records be stored?  Include 
information about:  password protection, encryption, physical controls, 
authorization of access, and separation of identifiers and data, as applicable.  
Include physical (e.g. paper) and electronic files. 
Response:  
The clinical staff will enter the clinical findings into the patient EMR during 
routine eye examination. The relevant study data from the clinical findings will be 
transcribed into a spread sheet and stored in password protected electronic files on 
a password protected network computer. The Excel data will include patient MRN 
to refer back to patients EMR to enter the study data. The MRN and DOB, and 
dates of surgery are the identifiers and the data is accessible only to the principal 
investigator, research coordinator and study team members. However, all 
identifiers will be removed once all the data of all the patients is extracted. A 
separate code key is not maintained.  
 
20.2 
A.  How long will the data be stored? 
Response:  

 
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Most of the study data include information that is usually collected in a routine 
eye examination. The relevant study data will be extracted from the EMR and 
transcribed into a spread sheet for data analysis. The de-identified transcribed data 
and any study related electronic file will be stored for at-least 3 years after the 
study has ended or kept indefinitely if the PI desires, or deleted at the PI’s 
discretion. Identifiers will be removed from this spreadsheet once all of the data is 
extracted from the EMR. The signed consent forms and IRB correspondence 
letters will be stored for 3 years after the study has been closed. 
 
20.3 
A.  Who will have access to the data? 
Response:  
Principal Investigator, Study Coordinator and other authorized research personnel 
involved in the study. De-identified data will be given to statistician for data 
analysis 
 
20.4 
A.  Who is responsible for receipt or transmission of the data? 
Response:  
Principal Investigator and Study Coordinator are responsible for authorization of 
transmission and for any communication of information 
 
20.5 
A.  How will the data be transported? 
Response: 
The research data from the EMR will be transferred to electronic files by 
manually entering the required data points into a spread sheet. The electronic files 
will be accessible only to Principal Investigator, Study Coordinator and other 
research personnel involved in the study 
 
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study 
specimens.   
 
☒ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 21.0) 
 
20.6 
B.  Where and how will all specimens be stored?  Include information 
about:  physical controls, authorization of access, and labeling of specimens, as 
applicable.   
Response:  

 
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20.7 
B.  How long will the specimens be stored? 
Response:  
 
20.8 
B.  Who will have access to the specimens? 
Response:  
 
20.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
 
20.10 B.  How will the specimens be transported? 
Response: 
 
 
21.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects* 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
 
NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require 
monitoring.  Some examples include:  exercising to exertion, or instruments that elicit 
suicidality or substance abuse behavior.  In such cases, N/A is not an acceptable 
response. 
 
21.1 Describe the plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Response:  
The intraocular pressure, visual acuity, cup-disc ratio, visual field testing, optic 
nerve imaging and medication list will be periodically evaluated for any changes. 
If the intraocular pressure seems elevated, or if any worsening in visual field 
testing or optic nerve imaging is detected, then the frequency of glaucoma 
medication will be changed to normalize the intraocular pressure. 
 
21.2 Describe what data are reviewed, including safety data, untoward events, 
and efficacy data. 
Response:  

 
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The intraocular pressure, visual acuity, visual field testing, optic nerve imaging, 
medication frequency and any surgical related complications will be reviewed 
 
21.3 Describe any safety endpoints. 
Response:  
Intra ocular pressure is attempted to be maintained to be less than 21mm Hg and 
is considered to be within normal limits. Any worsening of the glaucoma as 
determined by intraocular pressure elevation, reduced visual acuity, visual field 
testing, and optic nerve imaging will be monitored in follow-up visits 
 
21.4 Describe how the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Response:  
The information will be collected at patients follow up visits 
 
21.5 Describe the frequency of safety data collection. 
Response:  
Post-surgical Day 1, Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, 
and Month 24 
 
21.6 Describe who will review the safety data. 
Response:  
Principal Investigator 
 
21.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response:  
Once every (at least) 6 months 
 
21.8 Describe the statistical tests for analyzing the safety data to determine 
whether harm is occurring. 
Response:  
Mean percentage change in intraocular pressure, changes to visual acuity, increase 
or decrease in the medication and other surgical related complications will be 
analyzed 
 

 
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21.9 Describe any conditions that trigger an immediate suspension of the 
research. 
Response:  
The research involves a post-surgical follow up observation and there is no trigger 
for immediate suspension of study 
 
22.0 
Withdrawal of Subjects* 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
22.1 Describe anticipated circumstances under which subjects may be withdrawn 
from the research without their consent. 
Response:  
If a participant is unavailable for follow up visits and do not respond to contact 
requests 
 
22.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  
Include whether additional follow up is recommended for safety reasons for 
physical or emotional health. 
Response:  
There will be no need for termination procedures as the data involves post-
surgical follow up observation as a part of routine clinical follow up after surgery 
 
22.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial 
withdrawal from procedures with continued data collection, as applicable. 
Response:  
There will be no need for withdrawal procedures because record collected during 
routine eye examination can be used for continued evaluation of the treatment 
provided. The de-identified data up to the time of withdrawal will be retained and 
analyzed. 
23.0 
Risks to Subjects* 
23.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related to their participation in the research. 
Consider physical, psychological, social, legal, and economic risks.  Include 
a description of the probability, magnitude, duration, and reversibility of the 
risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 

 
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Response:  
There is risk of intra and post-operative complications and discomfort as in any 
routine eye surgery in general, and in any routine tube implantation procedure in 
particular as part of a patient’s standard of care. There is also risk of a breach of 
confidentiality of identifiable subject data. This risk is low as data will be stored 
on a network-connected, password protected computer. Also, the data is extracted 
from HIPPA compliant EMR records 
Economic Risk: Since tube shunt implantation is a routine surgical procedure for 
glaucoma and not experimental you and your insurance company will be billed 
for the health care services that you would ordinarily be responsible to pay for. In 
some cases, insurance will not pay for services ordinarily covered because these 
services were performed in relation to a research study. You should always check 
with your insurance to verify which services will be covered by your insurance 
and which you will be responsible to pay for.  
 
23.2 Describe procedures performed to lessen the probability or magnitude of 
risks, including procedures being performed to monitor subjects for safety. 
Response:  
In case of post-operative complication immediate treatment will be provided by 
the investigator to resolve the complication. Also, the primary and secondary end 
points will be monitored as per the scheduled visits to notify any deviation from 
the normal measurements. Clinical finding data of the patient is stored on the UB 
EMR. Data will be collected and stored on a password- protected, network 
computers as required by UB.  
 
Please see section 20.1 for procedures performed to mitigate the risk of breach of 
confidentiality.  
 
23.3 If applicable, indicate which procedures may have risks to the subjects that 
are currently unforeseeable. 
Response:  
There are no procedures in this research study that may have risks to the subjects 
that are currently unforeseeable 
 
23.4 If applicable, indicate which research procedures may have risks to an 
embryo or fetus should the subject be or become pregnant. 
Response:  
There are no procedures in this research study that may have risks to an embryo 
or fetus should the subject be or become pregnant. However, some SOC 

 
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medications may have an effect and we would exclude young females from the 
study to avoid such an issue. 
 
23.5 If applicable, describe risks to others who are not subjects. 
Response:  
There are no procedures in this research study that may have risks to others who 
are not subjects 
 
24.0 
Potential Benefits to Subjects* 
24.1 Describe the potential benefits that individual subjects may experience by 
taking part in the research.  Include the probability, magnitude, and 
duration of the potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response:  
There is no direct benefit to the participant by taking part in this study, which 
compares two available Standard of Care procedures. Possible benefits to patients 
are to identify which shunt is safer or more successful in lowering intraocular 
pressure. 
25.0 
Compensation for Research-Related Injury 
☐ 
N/A:  The research procedures for this study do not present risk of 
research related injury (e.g. survey studies, records review studies).  This 
section does not apply.   
25.1 
If the research procedures carry a risk of research related injury, 
describe the available compensation to subjects in the event that such 
injury should occur.   
Response: 
Research related injury is not anticipated and therefore there is no plan to 
compensate for study related injury 
 
25.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE:  If the contract is not yet approved at the time of this submission, submit the 
current version here.  If the contract is later approved with different language 
regarding research related injury, you must modify your response here and 
submit an amendment to the IRB for review and approval. 
Response:  
This is unfunded research and done as a part of clinical care and therefore there is 
no contract regarding compensation for research related injury 

 
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26.0 
Economic Burden to Subjects 
26.1 
Describe any costs that subjects may be responsible for because of 
participation in the research.   
NOTE:  Some examples include transportation or parking. 
Response:  
The patient’s private or public health insurance company (for example Medicare) 
will be billed for the procedure and the patient will be responsible for any co-
payment, co-insurance or deductible. The patient will not be charged for the cost 
of collecting the data for this study and other clinic visits and diagnostic tests 
done solely for the purposes of this study 
 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
27.0 
Compensation for Participation 
27.1 
Describe the amount and timing of any compensation to subjects, 
including monetary, course credit, or gift card compensation. 
Response:  
There is not compensation to subjects for participating in this study 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records 
review procedures only.  This section does not apply. 
☒ 
N/A:  There is no compensation for participation.  This section 
does not apply. 
28.0 
Consent Process 
28.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will 
be obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 29.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 29.0) 
 
28.2 Describe where the consent process will take place.  Include steps to 
maximize subjects’ privacy. 
Response:  
The consent will be taken by the Principal Investigator, Study Coordinator or 
research team member in a private examination room at the Ross Eye Institute 
with the door closed to respect the patient’s privacy 

 
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28.3 Describe how you will ensure that subjects are provided with a sufficient 
period of time to consider taking part in the research study.   
NOTE:  It is always a requirement that a prospective subject is given sufficient 
time to have their questions answered and consider their participation.  See “SOP: 
Informed Consent Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response: 
After providing subjects with information about the study and reviewing the 
consent documentation, patients will be given time to consider their participation, 
ask questions and sign the consent form before being enrolled in the study. If they 
would still like to review the consent documentation further they will be allowed 
to take the document home to review. Study staff will contact that individual 
within a week to answer any further questions and the subject will be provided 
study staff contact information if they decide to proceed at a later time. 
28.4 Describe any process to ensure ongoing consent, defined as a subject’s 
willingness to continue participation for the duration of the research study.   
Response:  
The patients are informed that their participation is voluntary and that they are 
free to withdraw from the study at any time and it will not be held against them. If 
a participant withdraws from the study, there will be no need for any withdrawal 
procedures because record collected during routine eye examination and follow-
up procedures will be used for continued evaluation of the treatment provided as a 
part of SOC. However, any data collected prior to withdrawal will be used for 
data analysis. Any future clinical notes after study withdrawal will not be used for 
data analysis 
28.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” Pay particular attention to Sections 5.4-5.9. If not, 
or if there are any exceptions or additional details to what is covered in the 
SOP, describe: 
• 
The role of the individuals listed in the application who are involved in 
the consent process 
• 
The time that will be devoted to the consent discussion 
• 
Steps that will be taken to minimize the possibility of coercion or 
undue influence 
• 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
☒ 
We have reviewed and will be following “SOP: Informed Consent Process 
for Research (HRP-090).” 
 
Non-English Speaking Subjects  

 
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☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 28.8) 
28.6 Indicate which language(s) other than English are likely to be 
spoken/understood by your prospective study population or their legally 
authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to 
Section 8.4 of this protocol. 
Response:  
 
28.7 If subjects who do not speak English will be enrolled, describe the process 
to ensure that the oral and written information provided to those subjects 
will be in that language, how you will ensure that subjects are provided with 
a sufficient period of time to consider taking part in the research study, and 
any process to ensure ongoing consent. Indicate the language that will be 
used by those obtaining consent.  
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research 
(HRP-090).” 
Response:  
Non English speaking subjects will not be recruited 
 
 
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 28.9) 
28.8   Describe the process to determine whether an individual is capable of 
consent.  
Response:  
 
 
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 28.13) 
When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 28.9 and 
28.10) and, where possible, assent of the individual should also be solicited 
(Sections 28.11 and 28.12). 

 
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28.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013)” for research in New 
York State.  
NOTE:  Examples of acceptable response includes: verifying the electronic 
medical record to determine if an LAR is recorded. 
Response:  
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
28.10 For research conducted outside of New York State, provide information 
that describes which individuals are authorized under applicable law to 
consent on behalf of a prospective subject to their participation in the 
research. One method of obtaining this information is to have a legal 
counsel or authority review your protocol along with the definition of 
“legally authorized representative” in “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).” 
Response:  
This study will only take place in NY State 
 
28.11 Describe the process for assent of the adults: 
• 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent 
and which will not. 
Response:  
None 
 
• 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response:  
It is not anticipated that the persons with cognitive impairment will be 
enrolled in this study 
 
28.12 Describe whether assent of the adult subjects will be documented and the 
process to document assent.   
NOTE:  The IRB allows the person obtaining assent to document assent on the 
consent document using the “Template Consent Document (HRP-502)” Signature 
Block for Assent of Adults who are Legally Unable to Consent. 
Response:  

 
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It is not anticipated that the persons with cognitive impairment will be enrolled in 
this study 
 
 
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☒ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 29.0) 
28.13 Describe the criteria that will be used to determine whether a prospective 
subject has not attained the legal age for consent to treatments or 
procedures involved in the research under the applicable law of the 
jurisdiction in which the research will be conducted (e.g., individuals under 
the age of 18 years).  For research conducted in NYS, review “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013)” 
to be aware of which individuals in the state meet the definition of 
“children.”  
NOTE:  Examples of acceptable responses include: verification via electronic 
medical record, driver’s license or state-issued ID, screening questionnaire. 
Response:  
This study does not involve children under age 18, who will be screened out 
during eligibility assessment by means of DOB verification from the medical 
record. 
 
28.14For research conducted outside of New York State, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved the research, under the applicable law of 
the jurisdiction in which research will be conducted.  One method of 
obtaining this information is to have a legal counsel or authority review 
your protocol along the definition of “children” in “SOP: Legally 
Authorized Representatives, Children, and Guardians (HRP-013).” 
Response:  
This study will only take place in NY State 
 
28.15 Describe whether parental permission will be obtained from: 
Response:  
This study does not involve children 
☐  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the 
child. 

 
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☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for 
the care and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is 
being requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination 
made by the IRB based on the risk level of the research.  For guidance, review the 
“CHECKLIST: Children (HRP-416).”  
28.16Describe whether permission will be obtained from individuals other than 
parents, and if so, who will be allowed to provide permission.  Describe 
your procedure for determining an individual’s authority to consent to the 
child’s general medical care. 
Response:  
This study does not involve children 
 
28.17 Indicate whether assent will be obtained from all, some, or none of the 
children.  If assent will be obtained from some children, indicate which 
children will be required to assent. 
Response:  
This study does not involve children 
 
28.18 When assent of children is obtained, describe how it will be documented. 
Response:  
This study does not involve children 
 
29.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☒ 
N/A:  A waiver or alteration of consent is not being requested. 
29.1 If the research involves a waiver or alteration of the consent process, please 
review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-
410)” to ensure that you have provided sufficient information for the IRB to 
make the determination that a waiver or alteration can be granted.   
NOTE:  For records review studies, the first set of criteria on the “CHECKLIST: 
Waiver or Alteration of Consent Process (HRP-410)” applies.  
Response:  

 
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A waiver is not being requested 
 
29.2 If the research involves a waiver of the consent process for planned 
emergency research, please review the “CHECKLIST: Waiver of Consent 
for Emergency Research (HRP-419)” to ensure you have provided sufficient 
information for the IRB to make these determinations.  Provide any 
additional information necessary here: 
Response:  
A waiver is not being requested 
 
30.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 31.0) 
30.1 Indicate whether you will be following “SOP: Written Documentation of 
Consent (HRP-091).” If not or if there are any exceptions, describe whether 
and how consent of the subject will be obtained including whether or not it 
will be documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written documentation of consent is normally 
required outside of the research context, the IRB will generally waive the 
requirement to obtain written documentation of consent.  This is sometimes 
referred to as ‘verbal consent.’  Review “CHECKLIST: Waiver of Written 
Documentation of Consent (HRP-411)” to ensure that you have provided sufficient 
information.  
If you will document consent in writing, attach a consent document with your 
submission.  You may use “TEMPLATE CONSENT DOCUMENT (HRP-
502)”.  If you will obtain consent, but not document consent in writing, attach the 
script of the information to be provided orally or in writing (i.e. consent script or 
Information Sheet).   
Response:  
 
☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
31.0 
Multi-Site Research (Multisite/Multicenter Only)* 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This 
section does not apply. 
 
31.1 
Indicate the total number of subjects that will be enrolled or records that 
will be reviewed across all sites. 

 
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Response:  
 
31.2 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as the following.  
• 
All sites have the most current version of the IRB documents, including 
the protocol, consent document, and HIPAA authorization. 
• 
All required approvals have been obtained at each site (including 
approval by the site’s IRB of record). 
• 
All modifications have been communicated to sites, and approved 
(including approval by the site’s IRB of record) before the 
modification is implemented. 
• 
All engaged participating sites will safeguard data as required by 
local information security policies. 
• 
All local site investigators conduct the study appropriately in 
accordance with applicable federal regulations and local laws. 
• 
All non-compliance with the study protocol or applicable requirements 
will be reported in accordance with local policy. 
Response:  
 
31.3 Describe the method for communicating to engaged participating sites.  
• 
Problems (inclusive of reportable events) 
• 
Interim results 
• 
Study closure 
Response:  
 
31.4 
If this is a multicenter study where you are a participating 
site/investigator, describe the local procedures for maintenance of 
confidentiality.  
• 
Where and how data or specimens will be stored locally? 
• 
How long the data or specimens will be stored locally? 
• 
Who will have access to the data or specimens locally? 
• 
Who is responsible for receipt or transmission of the data or 
specimens locally? 
• 
How data and specimens will be transported locally? 
Response:  
 
31.5 
If this is a multicenter study and subjects will be recruited by methods not 
under the control of the local site (e.g., call centers, national 

 
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advertisements) describe those methods.  Local recruitment methods are 
described elsewhere in the protocol. 
• 
Describe when, where, and how potential subjects will be 
recruited. 
• 
Describe the methods that will be used to identify potential 
subjects. 
• 
Describe materials that will be used to recruit subjects. (Attach 
copies of these documents with the application. For 
advertisements, attach the final copy of printed advertisements. 
When advertisements are taped for broadcast, attach the final 
audio/video tape. You may submit the wording of the 
advertisement prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final 
audio/video tape.) 
Response:  
 
32.0 
Banking Data or Specimens for Future Use* 
☒ 
N/A:  This study is not banking data or specimens for future use or 
research outside the scope of the present protocol.  This section does not 
apply. 
32.1 If data or specimens will be banked (stored) for future use, that is, use or 
research outside of the scope of the present protocol, describe where the 
data/specimens will be stored, how long they will be stored, how the 
data/specimens will be accessed, and who will have access to the 
data/specimens.  
NOTE:  Your response here must be consistent with your response at the “What 
happens if I say yes, I want to be in this research?” Section of the Template 
Consent Document (HRP-502). 
Response:  
 
32.2 List the data to be stored or associated with each specimen. 
Response:  
 
32.3 Describe the procedures to release banked data or specimens for future 
uses, including: the process to request a release, approvals required for 
release, who can obtain data or specimens, and the data to be provided with 
specimens. 
Response: