Conditions: Retinal Detachment
Keywords: Scleral Buckle Triamcinolone Acetonide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 14
Healthy volunteers: no

Brief summary:
PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery.

METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.

Detailed description:

Arms:
arm 1: No additional drug given arm 2: receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation

Interventions: intervention 1: Triamcinolone Acetonide 40mg/mL
Intervention descriptions: intervention 1: Sub-tenon irrigation 1cc

Protocol document:
Prot_SAP_000.pdf: 
Using Triamcinolone Acetonide to Reduce Pain after Scleral Buckle Surgery 
VT Research Protocol version 1.0.0 
Page 1 of 26 
Revised: February 9, 2019 
 
PROTOCOL TITLE: 
Using Triamcinolone Acetonide to Reduce Pain after Scleral Buckle Surgery 
 
PROTOCOL NUMBER: 
IRB 19-377 
 
PRINCIPAL INVESTIGATOR: 
Dr. Vishak John M.D. 
Retinal Surgery 
Vistar Eye Center, Virginia Tech Carilion School of Medicine  
 
FUNDING: 
 
This study does not require funding 
 
VERSION NUMBER/DATE: 
2.0     11.20.2019 
 
REVISION HISTORY:  
Use this table to keep track of changes. Add more rows as needed. 
 
Revision 
# 
Version Date 
Brief Summary of Changes  
(i.e., the different sections) 
Consent 
Change? 
0 
4/1/19 
 
 
1 
6/4/19 
Added compensation, pain protocol, 6 mo f/u, 
changed from WIRB to BRANY 
Yes 
2 
11/20/19 
Removed LGH study site 
Yes 
 
 
 
 
 
 
 
 
 
 
 


Using Triamcinolone Acetonide to Reduce Pain after Scleral Buckle Surgery 
VT Research Protocol version 1.0.0 
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Revised: February 9, 2019 
Table of Contents 
1.0 
Study Summary 
3 
2.0 
Objectives 
3 
3.0 
Background 
4 
4.0 
Study Endpoints 
6 
5.0 
Study Design and Statistical Analysis Plan 
6 
6.0 
Setting 
7 
7.0 
Study Intervention(s)/Investigational Agent(s) 
7 
8.0 
Procedures Involved 
8 
9.0 
Data and Specimen Long Term Storage and Use 
11 
10.0 Sharing of Results with Subjects 
12 
11.0 Study Timelines 
13 
12.0 Inclusion and Exclusion Criteria 
13 
13.0 Vulnerable Populations 
14 
14.0 Number of Subjects 
14 
15.0 Recruitment Methods 
15 
16.0 Withdrawal of Subjects 
15 
17.0 Risks to Subjects 
16 
18.0 Potential Benefits to Subjects 
19 
19.0 Data Management and Confidentiality 
19 
20.0 Provisions to Protect the Privacy Interests of Subjects 
20 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
21 
22.0 Compensation for Research Related Injury 
22 
23.0 Economic Burden to Subjects 
22 
24.0 Consent Process 
22 
25.0 Process to Document Consent in Writing 
24 
26.0 Resources Available 
24 
27.0 Multi-Site Research 
25 
 
 
 


Using Triamcinolone Acetonide to Reduce Pain after Scleral Buckle Surgery 
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1.0 
Study Summary 
 
Study Title 
Using Triamcinolone Acetonide to Reduce Pain after Scleral 
Buckle Surgery 
Study Design 
Simple Randomized Control Trial 
Primary Objective 
To assess pain reduction following scleral buckle surgery 
with sub-tenon irrigation of triamcinolone acetonide, as 
measured by 11-point Numerical Rating Scale at 24 hrs 
post-op 
Secondary 
Objective(s) 
• 
Pain at 1-2 week post-op visit (11 pt NRS scale) 
• 
Pain at 6 mo post-op phone call 
• 
Post-operative analgesic consumption 
• 
Post-operative nausea and vomiting score (0-6) 
Study Population 
Patients undergoing Scleral Buckle Surgery for 
rhegmatogenous retinal detachment at Vistar Eye Center 
Sample Size 
N = 48 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
• 1 cc Triamcinolone sub-tenon irrigation 
• Self-report survey at 24-hrs post-operative including 
11 pt pain scale, nausea and vomiting score 
• Pill Count at 24-hrs post-operative 
• Self-report survey at 1-2 week post-operative 
including 11 pt pain scale, analgesic consumption, 
nausea and vomiting score 
• Pill Count at 1-2 weeks post-operative 
• Intra-ocular pressure measurement at 24 hrs post-
operative 
• Intra-ocular pressure measurement at 1-2 week post-
operative 
Study Duration for 
Individual 
Participants 
90 mins for the surgery (standard medical procedure) + 30s 
for experimental procedure + 2 minutes for each survey 
Each pt. is enrolled for 2 weeks. 
Acronyms and 
Definitions  
IOP- Intraocular Pressure 
NRS- Numerical Rating Scale for Pain  
EMR- Electronic Medical Record 
TA- Triamcinolone Acetonide 
 
 
2.0 
Objectives 
2.1 The purpose of this study is to determine if sub-tenon irrigation with 
triamcinolone acetonide at the time of surgery for rhegmatogenous retinal 
detachment will reduce the pain and inflammation caused by scleral 
buckle surgery. 
2.2 Primary Hypothesis: Sub-tenon irrigation with 1cc (40 mg) Triamcinolone 
Acetonide will significantly reduce post-operative pain at 24 hrs post-


Using Triamcinolone Acetonide to Reduce Pain after Scleral Buckle Surgery 
VT Research Protocol version 1.0.0 
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Revised: February 9, 2019 
operation in patients undergoing scleral buckle surgery for 
rhegmatogenous retinal detachment. 
 
Secondary Hypotheses: 
Peri-bulbar irrigation with 1cc (40 mg) Triamcinolone Acetonide will 
significantly reduce post-operative analgesic consumption at 24 hrs post-
operation in patients undergoing scleral buckle surgery for 
rhegmatogenous retinal detachment 
Peri-bulbar irrigation with 1cc (40 mg) Triamcinolone Acetonide will 
significantly reduce post-operative nausea and vomiting score at 24 hrs 
post-operation in patients undergoing scleral buckle surgery for 
rhegmatogenous retinal detachment 
Peri-bulbar irrigation with 1cc (40 mg) Triamcinolone Acetonide will 
significantly reduce post-operative pain at 1-2 week post-operation in 
patients undergoing scleral buckle surgery for rhegmatogenous retinal 
detachment. 
Peri-bulbar irrigation with 1cc (40 mg) Triamcinolone Acetonide will 
significantly reduce post-operative pain at 6 month post-operation in 
patients undergoing scleral buckle surgery for rhegmatogenous retinal 
detachment. 
Peri-bulbar irrigation with 1cc (40 mg) Triamcinolone Acetonide will 
significantly reduce post-operative analgesic consumption at 1-2 week 
post-operation in patients undergoing scleral buckle surgery for 
rhegmatogenous retinal detachment 
Peri-bulbar irrigation with 1cc (40 mg) Triamcinolone Acetonide will 
significantly reduce post-operative nausea and vomiting score at 1-2 week 
post-operation in patients undergoing scleral buckle surgery for 
rhegmatogenous retinal detachment 
 
3.0 
Background 
3.1 Summarize the relevant prior research on this topic and gaps in current 
knowledge within the field of study. 
Scleral buckle surgery is a widely used ophthalmic surgery for the 
correction of primary rhegmatogenous retinal detachment. Research 
suggests that it is of equal efficacy as pars plana vitrectomy and that most 
eyes retain visual acuity for 20 years after surgery. Studies also suggest 
that eye pain is a common and underestimated occurrence after 
vitreoretinal surgery for retinal detachment, with 56% of patients reporting 
intense pain post-operatively. Levels of post-operative nausea were also 
correlated to the level of pain experienced.1 In a study on chronic pain 
following scleral buckle surgery, it was shown that all patients 


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experienced pain following the surgery, with a wide range of subject pain 
scores. 18% of these patients experienced chronic pain for >6 months 
following surgery. Patients who experienced chronic pain showed higher 
pain scores in the immediate post-operative period.2 Local inflammation 
has been shown to be associated with eye pain in the first few days after 
surgery.1 It has also been shown that reduction of swelling following 
scleral buckle surgery reduces pain following surgery.3 Triamcinolone 
acetonide is a corticosteroid that is used extensively in ophthalmology for 
many indications including uveitis, vasculitis, proliferative 
vitreoretinopathy, macular degeneration, and macular edema. 
Triamcinolone works by inhibiting phospholipase A2 induction, and 
thereby downregulating inflammatory mediators including interleukins, 
prostaglandins and tumor necrosis factor. Corticosteroids also have been 
shown to have profound anti-angiogenic effects, vasoconstrictive effects, 
anti-permeability effects, ability to help maintain blood-retinal barrier, and 
facilitation of exudate reabsorption. Furthermore, triamcinolone has 
relatively small particles, allowing it to be injected in or around the eye, 
and has a duration of action of several months.4 Surgery in and around the 
eye has been shown to cause intraocular inflammation, called uveitis. 
Corticosteroids are currently the cornerstone of treatment for uveitis. A 
study of perioperative intravitreal injection of triamcinolone during pars 
plana vitrectomy for open globe trauma demonstrated a improvement in 
visual acuity, likely due to the anti-inflammatory effects of triamcinolone.5 
Another study using triamcinolone with bupivacaine as a peribulbar 
injection at the conclusion of surgery for retinal detachment demonstrated 
a reduction in the use of hydrocodone following surgery, and 
demonstrated a trend of reduced pain, though it did not reach full 
significance.6 As of yet, there is no definitive management method for 
reducing pain and swelling following scleral buckle surgery. We will be 
employing a sub-tenon irrigation approach to deliver 1cc of 40 mg / mL 
triamcinolone directly on the sutured area to reduce pain following surgery 
to try to address this gap. 
 
3.2 Describe any relevant preliminary data 
The use of Triamcinolone Acetonide sub-tenon irrigation has been done as 
standard at Vistar for scleral buckle surgeries for the last 2 years by Dr. 
Vishak John and Dr. Michael McClintock. Observations by the two 
surgeons suggest that there is a great analgesic effect for patients 24 hours 
post-surgically when compared to patients not given TA. There have been 
no noted adverse effects resulting from this use.  
3.3 Based on the existing literature, provide the scientific or scholarly 
rationale for and significance of your research and how will it add to 
existing knowledge. 


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Currently, there does not appear to be any definitive standard of care for 
reduction of post-operative pain and swelling following scleral buckle 
surgery, as demonstrated by the wide variety of techniques employed.7 
Multiple Vistar surgeons currently use Triamcinolone Acetonide for all 
scleral buckle surgeries within the system, but this practice has not yet 
been proven in a randomized control trial. Some physicians are 
prescribing opioids to control pain following scleral buckle surgery6; in 
today’s environment of opioid crises, this is something we would like to 
avoid. The significance of this study is that if the outcome is positive, it 
will help to determine a definitive standard of care for reducing pain and 
swelling following scleral buckle surgery that will allow reduced 
prescription of narcotics.  
4.0 
Study Endpoints 
4.1 Describe the primary and secondary study endpoints 
Primary Endpoint: 
• Statistically significant reduction in pain as measured by 11-
point Numerical Rating Scale at 1-day post-op. We are 
powered to detect a reduction in 2 points on the NRS scale. 
 
Secondary Endpoints: 
• Statistically significant reduction in pain as measured by 11-
point Numerical Rating Scale at 1-2 weeks post-op. 
• Statistically significant reduction in pain as measured by 11-
point Verbal Rating Scale at 6 months post-op. 
• Significant reduction in analgesics consumed post-
operatively (self-reported pill count) at 1-day post op 
• Significant reduction in analgesics consumed post-
operatively (self-reported pill count) at 1-2 weeks post op 
• Significant reduction in Nausea and Vomiting Score at 1 day 
post-op. 
• Significant reduction in Nausea and Vomiting Score at 1-2 
weeks post-op. 
4.2 Describe any primary or secondary safety endpoints. These should be 
included for all studies that are greater than minimal risk. 
• Primary: No significant difference in ocular hypertension 1-2 
weeks post-operatively, defined as IOP of >5mmHg above 
baseline 
• Secondary:  
o No significant difference in infections following surgery 
o No significant difference in hypersensitivity following 
surgery 
5.0 
Study Design and Statistical Analysis Plan 


Using Triamcinolone Acetonide to Reduce Pain after Scleral Buckle Surgery 
VT Research Protocol version 1.0.0 
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5.1 Describe the basic study design/approach  
Simple randomized controlled trial comparing two groups in reducing post-
operative pain from scleral buckle surgery -  
1. Peribulbar irrigation of triamcinolone acetonide (Experimental Group) 
2. Balanced Salt Solution (Control Group) 
 
5.2 Describe corresponding data analysis plan/approach  
 
Parametric analysis of experimental and control groups using students’ t-test 
for primary endpoint, secondary endpoint of pain and analgesic 
consumption will be analyzed similarly. Secondary endpoints of nausea and 
vomiting score will be analyzed via non-parametric analysis (Mann-
Whitney U test) 
 
6.0 
Setting 
6.1 Describe the sites or locations where your research team will conduct the 
research. 
● 
Identify where your research team will identify and recruit potential 
subjects. 
● 
Vistar Eye Centers of VA:  
o 5296 Peters Creek Rd, Roanoke VA 24019 
o 2154 McVitty Rd, Roanoke VA 24018 
o 2617 Sheffield Dr, Blacksburg VA 24060 
o 749A East Church St, Martinsville VA 24112 
o 710 West Ridge Rd, Wytheville VA 24382 
o 280 Westlake Rd Bldg 2, Hardy VA 24101 
 
● 
Identify where the team will perform the research procedures. 
 
o Vistar Eye Surgery Center 
2154 McVitty Rd SW, Roanoke, VA 24018 
 
 
7.0 
Study Intervention(s)/Investigational Agent(s) 
7.1 Describe the study interventions (including behavioral interventions) and/or 
investigational agents (e.g., drugs or devices) to be used in this study.  
● 
Drug/Device Handling: 
Triamcinolone will be stored in the operating facility according to 
package instructions: at controlled room temperature, 20° to 25°C 
(68° to 77°F. Vial will be stored in carton to protect from light, and 
will be stored upright. In the operating room, the vial will be opened 
according to sterile procedure by a nurse and prepared for injection 
by the surgeon.  


Using Triamcinolone Acetonide to Reduce Pain after Scleral Buckle Surgery 
VT Research Protocol version 1.0.0 
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Revised: February 9, 2019 
7.2 List the name of all drugs (including any vitamins, supplements, herbs, or 
nicotine) to be used in the study.  Indicate whether they have FDA 
approval, and list any limitations for their use.  
Triamcinolone Acetonide injectable suspension. FDA Approved. 
Marcaine (Bupivacaine Hydrochloride .75%). FDA Approved. 
7.3 List all devices, how they will be used, their purpose in the study, and if 
they will be used in a manner consistent with their approved uses. If they 
will be used in ways that are not yet FDA approved, indicate whether they 
need an IDE or a determination that they are exempt from the IDE 
Determination. If a determination of significant risk or non-significant risk 
is needed for any of the devices, include the researcher’s recommendation 
for each of those devices. 
N/A 
7.4 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:  
N/A 
 
8.0 
Procedures Involved 
8.1 Describe and explain the study design. 
Randomized Control Trial. Subjects will be patients at Vistar Eye Center 
who are undergoing scleral buckle surgery for rhegmatogenous retinal 
detachment. Patients of this indication will be consented and enrolled in 
the trial as detailed in section 24, and randomized (by coin-flip) into one 
of two arms, the control or the experimental. Patients in both arms of the 
study will be screened for IOP via handheld digital tonometry (tonopen) 
and will undergo standard scleral buckle procedures, including irrigation 
with 1 ml .75% Marcaine for local anesthesia (as is standard for all 
surgeries). At time of surgery, patients in the experimental group will 
receive irrigation of 1 ml (40 mg/mL) triamcinolone around the bed of 
applied scleral buckle distributed equally in all 4 quadrants (.25 ml per 
quadrant) under the tenon layer of the eye. Patients in the control group 
will be given irrigation around the applied scleral buckle of 1 ml balanced 
salt solution instead of triamcinolone. Patients will be masked to the 
treatment group assignment. The surgeon cannot be masked, as the 
triamcinolone solution is white and the balanced salt solution is clear. 
Intraoperative details will be recorded in the EMR about the surgery in 
both groups, including duration of surgery, time of irrigation, any 
additional pharmaceuticals or anesthesia applied, procedures performed, 
and placement of the buckle. Patient will receive a pill-count form at the 
end of the visit to keep track of rescue analgesic consumption. All patients 


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will be given appointments for post-operative day 1, and 1-2 weeks post-
operative as is standard practice.  
On post-operative day one, primary outcome data will be obtained by a 
blinded examiner who will be giving the patient a form which asks about 
the patient’s pain score by reference to an 11-point numbered rating scale 
(0-10). On the same form, patients will also be asked about post-operative 
nausea and vomiting for secondary endpoint, which will be scored from 0-
6 by adding the points for question II and question III from the pain and 
nausea survery8. The form will be collected by the same examiner when 
completed. Pill count sheet will be collected and additional sheet will be 
given for patient to track analgesic use between first and second visit. 
Patient will then have regularly scheduled visit with the surgeon who will 
be screening the patient for success of surgery, adverse events, and will 
examine pain and nausea scores to ensure both are well controlled. The 
physician will be ensuring the patient’s safety, and will be allowed to 
prescribe any medications deemed medically necessary for control of side 
effects, nausea, and pain. IOP of all patients will also be measured at this 
visit.  
At second post-operative visit (1-2 weeks), patients’ IOP will be measured 
again for safety endpoint. Patient pill count sheet will be collected. 
Patients will be filling out 11-point NRS pain score and post-operative 
nausea and vomiting sheet again during office visit and it will be collected 
by blinded examiner. Patient will then be examined by surgeon again for 
success of surgery, adverse events, and control of pain and nausea. 
 
Before 
Surgery 
Day of 
Surgery 
Between 
Surgery 
and First 
Follow-Up 
Visit 
First 
Follow-
Up Visit 
(1 day 
after 
surgery) 
Between 
1st and 2nd 
Follow-Up 
Visits 
Second 
Follow-
Up Visit 
(1-2 
weeks 
after 
surgery) 
Long-
Term 
Follow-
Up (6 
months
) 
Location 
Clinic 
Surgery 
Center 
Home 
Clinic 
Home 
Clinic 
Phone 
Procedure
s 
The 
doctor 
will 
explain 
the study 
to 
patient 
Everyone: 
Scleral 
Buckle 
Surgery. 
Experimental 
Group: 
Triamcinolon
e (steroid) 
will be 
applied 
during 
surgery. 
Control 
Group: Saline 
solution will 
 
Everyone
: will be 
examine
d by the 
doctor 
for safety 
 
Everyone
: will be 
examine
d by the 
doctor 
for safety 
 


Using Triamcinolone Acetonide to Reduce Pain after Scleral Buckle Surgery 
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Revised: February 9, 2019 
be applied 
during 
surgery. 
What 
Patient 
will do 
Review 
and sign 
the 
consent 
documen
t 
Receive pill 
count form 
Keep track 
of pain 
medication
s taken on 
pill-count 
form 
Fill out 
pain and 
nausea 
form. 
Turn in 
pill-count 
and 
receive 
second 
pill-count 
Keep track 
of pain 
medication
s taken on 
pill-count 
form 
Fill out 
pain and 
nausea 
form. 
Turn in 
pill-count 
Report 
pain 
level 
from 0-
10 
 
 
 
8.2 Describe: 
● 
Procedures or safeguards intended to reduce the probability and 
magnitude of risks. 
 
Patients will be screened twice for IOP (measured by tonometer) 
post-surgically to check for ocular hypertension. Patients eyes will 
also be examined at both visits by the primary surgeon via slit-lamp 
to determine any adverse events as a result of surgery or the 
intervention. The surgeon is responsible for the medical safety of all 
patients and may prescribe any medications deemed necessary for 
control of side effects of surgery or intervention, including nausea 
and vomiting. 
 
● 
Be sure to describe all drugs and devices used in the research, when 
they will be administered or used, and their purpose.  
See 7.1 
 
Methods used to collect data about subjects. Please upload all data 
collection forms to Protocol Management 
● 
Pain and Nausea Survey 
● 
Pill-Count 
● 
IOP (tonometry) 
8.3 What data will you collect during the study and how you will obtain them? 
Please include descriptions of electronic data collection, database 
matching, and app-based data collection. 
Patients will be assigned an arbitrary patient ID at beginning of the study 
which is recorded in the EMR. Demographic data about patient age, 
gender, and ethnicity will be extracted from the electronic medical record. 
No patient identifying data including name, addresses, date of birth, or 


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SSN will be extracted from the electronic medical record for the purpose 
of the analysis. Details of surgery will be extracted from the EMR.  
During the study, IOP will be collected at two time-points via tonometer. 
This data will be extracted from the electronic medical record for analysis. 
Pain level via 11-pt NRS will be collected at two time points by survey. 
Data about analgesic consumption will be collected via survey form at two 
time points by survey. Nausea and vomiting score will be collected at two 
time points by survey. This data will be matched to de-identified patient 
ID. Physical survey forms will then be confidentially discarded. 
8.4 Who will transcribe or code audio and/or video recordings? 
N/A 
8.5 Include a description of any deception to be used in the study.  
N/A 
  
8.6 If the study involves long-term follow-up (once all research related 
procedures are complete), describe what data will be collected during the 
follow up period and when it will occur.  
N/A 
9.0 
Data and Specimen Long Term Storage and Use 
9.1 If you will store data or specimens for future use, describe where you will 
store the data or specimens, how long they will be stored, and how and by 
whom the data or specimens will be accessed. 
Data from the study including IOP, procedure performed, and whether or 
not triamcinolone was applied will continue to remain as part of patient 
data within Vistar Electronic Medical Record for the purposes of medical 
care. 
9.2 For specimens, list the data to be stored or associated with each specimen. 
N/A 
9.3 Describe the procedures to release data or specimens outside of the 
research team, including the process to request a release, approvals 
required for release, who can obtain data or specimens, and what data 
will be provided with specimens. 
N/A 
9.4 Describe the identifiers to be included with stored data or specimens, as 
well as any key or code that could be used to make them identifiable. 
Describe where the code will be stored, who will have access to it, and 
when it will be destroyed. 
Data will be stored with arbitrary patient ID and will not be identifiable. A 
code to re-identify patients will be with the PI (Dr. John) and nobody else 


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will have access to it. It will be destroyed after publications of the results 
of the study 
9.5 Please select the identifiers you will obtain (whether directly from 
participants or from another source), including but not limited to: 
 
☐ 
Name 
☐ 
Geographical subdivisions smaller than a state, including street address, 
city, county, precinct, zip code, and equivalent geocodes (note, the initial 
three digits of a zip code are not considered identifiable) 
☐ 
Elements of dates (except year) for dates directly related to an individual, 
including birth date, admission date, discharge date, date of death, and 
single year of age over 89 and all elements of dates (including year) 
indicative of such age (note, such ages and elements may be aggregated 
into a single category of age 90+) 
☒ 
Phone numbers 
☐ 
Fax numbers 
☐ 
Electronic mail addresses (e-mail) 
☐ 
Social Security numbers 
☐ 
Medical record numbers 
☐ 
Health plan beneficiary numbers 
☐ 
Account numbers 
☐ 
Certificate/license numbers 
☐ 
Vehicle identifiers and serial numbers, including license plate numbers 
☐ 
Device identifiers and serial numbers 
☐ 
Web Universal Resource Locators (URLs) 
☐ 
Internet protocol (IP) address numbers 
☐ 
Biometric identifiers, including finger and voice prints (audio recording) 
☐ 
Full face photographic images and any comparable images (including 
video recording) 
☐ 
Student record number or identification number   
☐ 
User name for online or computer accounts 
☐ 
Any other unique identifying number, characteristic, or code (note this 
does not mean the unique code assigned by the investigator to code the 
data): (Explain)    
 
10.0 Sharing of Results with Subjects 
10.1 Describe whether you will share results (study results or individual 
subject results, such as results of investigational diagnostic tests, genetic 
tests, or incidental findings) with subjects or others (e.g., the subject’s 
primary care physician). If so, describe how you will share the results and 


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include this information as part of the consent document. Upload 
materials you will use to explain the results to subjects. 
We will not be sharing results with subjects. 
 
11.0 Study Timelines 
11.1 Describe: 
● 
The duration of an individual subject’s participation in the study (for 
example, 1 hour, 2-4 weeks, 3-5 years). 
● 
6 months 
● 
The amount of time expected to enroll all study subjects (weeks, 
months, years, etc.) 
● 
Approximately 17-24 months 
● 
The amount of time expected for the investigators to complete this 
study including primary data analyses. 
● 
Approximately 2.5 years 
12.0 Inclusion and Exclusion Criteria 
12.1 Describe how you will screen individuals for eligibility. When will 
screening occur and what procedures will you use? Upload any screening 
scripts or surveys to Protocol Management. 
Individuals will be screened at time of diagnosis. All patients who are 
determined to need scleral buckle surgery for rhegmatogenous retinal 
detachment will be screened for eligibility. Screening for the trial will be 
done by the surgeon, who will be reviewing the medical history at time of 
visit via EMR. If patient does not fail the exclusion criteria, the patient 
will be consented for enrollment in the trial. There are no screening scripts 
or surveys that will be used. 
12.2 Describe the eligibility criteria that define who will be included and who 
will be excluded from enrollment for each procedure of your study.  
Inclusion Criteria: Patient must have rhegmatogenous retinal detachment 
and be scheduled to undergo scleral buckle surgery for correction.  
Exclusion Criteria:  
• Patient under 18 years old 
• Advanced Glaucoma 
• History of corticosteroid responsive elevation in IOP 
• Allergy to Triamcinolone Acetonide or other corticosteroids 
• Pre-existing chronic pain disorders 
• Herpes zoster 
• Prior corneal allograft 
• Allergy to local anesthetic or penicillin 


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Revised: February 9, 2019 
• Patients unable to consent on own behalf 
• Patients unable to communicate pain and nausea levels 
• Pregnancy 
• Incarceration 
 
12.3 Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of these 
populations as subjects in your research unless you indicate them in the 
description of your subject population.) 
All of the following populations will be excluded from our study. 
● 
Minors, as defined by state law where the study is performed 
(infants, children, teenagers) 
● 
Pregnant women  
● 
Prisoners (including all incarcerated individuals) 
● 
Adults not capable to consent on their own behalf 
 
13.0 Vulnerable Populations 
13.1 If the research involves individuals who are vulnerable to coercion or 
undue influence, please describe additional safeguards you will include to 
protect their rights and welfare. 
N/A 
 
14.0 Number of Subjects 
14.1 Indicate the total number of subjects to be enrolled and how this number 
was determined 
Sample Size Calculation as performed by Dr. Allison Tegge of VT and 
VTCSOM 
H0= median post-operative pain equal in experimental and control groups 
HA= median post-operative pain not equal in experimental and control 
groups 
Median Pain Score Experimental: 1. SD = 1, IQR = 0-2 
Median Pain Score Control: 3. SD = 2.5, IQR = .5 – 5.5 
Alpha = .01, Power = 0.8 
Effect Size, d = 1.05 
Sample Size: n = 48 
 
14.2 If this is a multi-site study, indicate the number of subjects to be enrolled 
at this site and the total to be enrolled from all sites. 


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n/a 
14.3 If applicable, indicate the number of potential subjects you expect to 
screen for enrollment, and the number of subjects you will need to 
complete the research procedures. 
n/a 
14.4 If the study has more than one procedure, indicate the total number of 
subjects to undergo each procedure separately. 
n/a 
15.0 Recruitment Methods 
15.1 Describe when, where, and how you will recruit potential subjects. 
Subjects will be recruited in the physician’s office at Vistar Eye Center at 
time of surgery scheduling via the recruitment script attached. The 
surgeon (VJ, MM) or research coordinator (PV) will be recruiting the 
patients as they are the most familiar with the patient’s medical history, 
potential drug complications, and have the best ability to address medical 
questions.  
15.2 Describe the source of subjects (for example, clinic patients with specific 
conditions, students in the library, community members at a gathering, or 
members of a local gym). 
Patients with rhegmatogenous retinal detachment with indication for 
scleral buckle surgery at Vistar Eye Center  
15.3 Describe the methods that you will use to identify potential subjects. 
All patients who present with indication for scleral buckle surgery are 
considered potential subjects. 
15.4 Describe materials that you will be use to recruit subjects. Attach copies 
of these documents with this protocol in Protocol Management and be 
sure to include the IRB protocol number on each document.  
Recruitment script can be found attached. 
● Describe any compensation to subjects. Separate compensation into 
appropriate categories, such as: reimbursement for expenses, time and 
effort, and additional incentives for study participation.  For each 
category, specify the amount (including any pro-rated amount), schedule, 
and method of payment. 
● $20 total compensation for completion of the study (will be disbursed after 
6 month follow-up phone call) 
 
16.0 Withdrawal of Subjects 
16.1 Describe circumstances under which you anticipate subjects could be 
withdrawn from the research without their consent. 


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• The research is canceled by the FDA or the sponsor 
• Patient is unable to keep scheduled appointments  
• A patient has a side effect that requires stopping the research 
16.2 If applicable, describe any procedures for orderly termination (e.g., 
discontinuation of a study drug or debriefing after a behavioral 
intervention). 
N/A 
16.3 Describe procedures that you will follow when subjects withdraw from the 
research, including partial withdrawal from procedures with continued 
data collection (e.g., participant declines to continue with regular blood 
draws, but continues with periodic behavioral questionnaires). 
If the patient withdraws consent to study before the time of surgery, the 
patient will not receive either the experimental or control treatments, and 
will receive standard surgical treatment. The patient’s data will not be 
extracted from the EMR for study purposes, and the patient will not be 
given any of the survey materials. If a patient withdraws consent after the 
surgery, the patient’s data will not be extracted from the EMR for analysis 
and the patient will be given no further survey materials. Existing survey 
materials will be destroyed. If patient partially withdraws from procedures 
after surgery, the data may be used except for that which is not completed. 
17.0 Risks to Subjects 
17.1 List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in the 
research.  
Adverse event data was collected by the FDA from 300 published 
articles containing data from controlled and uncontrolled clinical trials 
which evaluated over 14,000 eyes treated with different concentrations 
of triamcinolone acetonide. The most common dose administered within 
these trials was triamcinolone acetonide 40 mg administered as primary 
or adjunctive therapy primarily as a single injection. The most common 
reported adverse events following administration of triamcinolone 
acetonide were elevated intraocular pressure and cataract progression. 
These events have been reported to occur in 20-60% of patients. Less 
common reactions occurring in up to 2% include endophthalmitis 
(infectious and non-infectious), hypopyon, injection site reactions 
(described as blurring and transient discomfort), glaucoma, vitreous 
floaters, and detachment of retinal pigment epithelium, optic disc 
vascular disorder, eye inflammation, conjunctival hemorrhage and visual 
acuity reduced. Cases of exophthalmos have also been reported. 
Risk of infection: Corticosteroids may mask some signs of infection, 
and new infections may appear during their use. There may be decreased 
resistance and inability to localize infection when corticosteroids are 


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used. Corticosteroids may enhance the establishment of secondary 
ocular infections due to fungi or viruses. If an infection occurs during 
corticosteroid therapy, it will be promptly controlled by suitable 
antimicrobial therapy.  
Elevated Intraocular Pressure: Increases in intraocular pressure 
associated with triamcinolone acetonide injection have been observed in 
20-60% of patients. This may lead to glaucoma with possible damage to 
the optic nerve. Effects on intraocular pressure may last up to 6 months 
following injection and are usually managed by topical glaucoma 
therapy. A small percentage of patients may require aggressive non-
topical treatment. Intraocular pressure as well as perfusion of the optic 
nerve head will be monitored and managed appropriately. As our study 
will be irrigating the peribulbar space rather than injecting into the 
posterior capsule of the eye, we expect our rate of elevated IOP to be 
much lower than that determined by the FDA. 
Endophthalmitis: The rate of infectious culture positive 
endophthalmitis is 0.5%. Proper aseptic techniques will always be used 
when administering triamcinolone acetonide. In addition, patients will 
be monitored following the injection to permit early treatment should an 
infection occur.  
Cataracts: Use of corticosteroids may produce cataracts, particularly 
posterior subcapsular cataracts. As our study will be irrigating the sub-
tenon’s space rather than injecting into the posterior capsule of the eye, 
we expect our rate of cataracts to be much lower than that determined by 
the FDA. 
Patients with Ocular Herpes Simplex: Corticosteroids should be used 
cautiously in patients with ocular herpes simplex because of possible 
corneal perforation. Corticosteroids should not be used in active ocular 
herpes simplex. We will be excluding all patients with ocular herpes 
simplex. 
 
Systemic reactions are exceedingly rare in ophthalmic administration of 
corticosteroids but are included below for completeness: 
Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac 
enlargement, circulatory collapse, congestive heart failure, fat embolism, 
hypertrophic cardiomyopathy in premature infants, myocardial rupture 
following recent myocardial infarction, pulmonary edema, syncope, 
tachycardia, thromboembolism, thrombophlebitis, vasculitis 
Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous 
atrophy, dry scalp, edema, facial erythema, hyper or hypo-pigmentation, 
impaired wound healing, increased sweating, petechiae and ecchymoses, 
rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile 
skin, thinning scalp hair, urticaria 


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Endocrine: Abnormal fat deposits, decreased carbohydrate tolerance, 
development of Cushingoid state, hirsutism, manifestations of latent 
diabetes mellitus and increased requirements for insulin or oral 
hypoglycemic agents in diabetics, menstrual irregularities, moon facies, 
secondary adrenocortical and pituitary unresponsiveness (particularly in 
times of stress, as in trauma, surgery or illness), suppression of growth in 
children 
Fluid and Electrolyte Disturbances: Potassium loss, hypokalemic 
alkalosis, sodium retention 
Gastrointestinal: Abdominal distention, elevation in serum liver 
enzymes levels (usually reversible upon discontinuation), hepatomegaly, 
hiccups, malaise, nausea, pancreatitis, peptic ulcer with possible 
perforation and hemorrhage, ulcerative esophagitis 
Metabolic: Negative nitrogen balance due to protein catabolism 
Musculoskeletal: Aseptic necrosis of femoral and humeral heads, 
charcot-like arthropathy, loss of muscle mass, muscle weakness, 
osteoporosis, pathologic fracture of long bones, steroid myopathy, 
tendon rupture, vertebral compression fractures 
Neurological: Arachnoiditis, convulsions, depression, emotional 
instability, euphoria, headache, increased intracranial pressure with 
papilledema (pseudo-tumor cerebri) usually following discontinuation of 
treatment, insomnia, meningitis, neuritis, neuropathy, 
paraparesis/paraplegia, paresthesia, sensory disturbances, vertigo 
Reproductive: Alteration in motility and number of spermatozoa. 
 
● Privacy (e.g., potential for personal information being accessed, used, 
or disclosed without the subjects’ knowledge or consent, breach of 
confidentiality/security) 
 
● In any clinical trial, there is a possibility for patient’s personal 
information being accessed improperly. This has been minimized as 
much as possible through participation in CITI training by main 
investigators, as well as not extracting patient identifying information 
from the EHR for analysis purposes.  
 
● Economic (e.g., potential for individuals to lose access to economic 
services, employment, insurability) 
● There will be no additional charge for TA treatment to the patient. 
17.2 If applicable, indicate which procedures might have risks to the subjects 
that are currently unforeseeable. This will be rare, and usually applicable 
when testing a new drug or device or a new use of an existing drug or 
device. 


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TA is a very well-studied drug that has been FDA approved since 1957 for 
ophthalmic application. It is unlikely there will be risks associated with the 
drug that have not been previously documented.  
17.3 If applicable, indicate which procedures might have risks to an embryo or 
fetus should the subject be or become pregnant. 
Triamcinolone is Pregnancy Category D, as it has been shown to increase 
rate of cleft lip in the first trimester when used systemically. It is unlikely 
to have this effect when applied locally to the eye, but some risk exists 
nonetheless. 
17.4 If applicable, describe risks to others who are not subjects (e.g., collection 
of sensitive health data that might affect sexual partners if disclosed, 
mandatory reporting of abuse, DNA testing that might affect family 
members or relationships). 
N/A 
18.0 Potential Benefits to Subjects 
18.1 Describe the potential benefits that individual subjects might experience 
from participating in the research. Include the probability, magnitude, and 
duration of the potential benefits, as this will be useful to the IRB’s 
risk:benefit analysis. Do not include benefits to society or others. These 
should be included in section 2 or 3 of this document. 
The largest benefit to subjects is the possibility to directly reduce pain 
following scleral buckle surgery. This is our primary outcome so the exact 
likelihood and magnitude are currently unknown, but likelihood is 
presumed to be high based on background literature. Magnitude is 
presumed to be around 50% reduction in pain. Subjects may also 
experience a decrease in intraocular inflammation, and post-operative 
nausea and vomiting. Furthermore, patients may have a reduced risk for 
addiction to pain medication, as we hope to demonstrate a reduced need 
for post-operative analgesics following surgery. All patients in the 
experimental group will also be receiving the treatment at no additional 
cost to them, which is a potential financial benefit. 
19.0 Data Management and Confidentiality 
19.1 Describe procedures that you will use for quality control to ensure validity 
of collected data. 
The surgeon will be including their subjective assessment of patient’s pain 
on the EHR, which they may compare to the patients written assessment 
as a form of quality control. 
19.2 Describe the steps that you will take to handle and secure study data 
during data collection, storage, use, and transmission.  Include 
information about training of study staff, authorization of access, 


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password protection, encryption, physical controls, certificates of 
confidentiality, separation of identifiers and data, etc. 
Patient data is stored securely in NextGen Electronic Medical Record at 
Vistar Eye Center according to HIPAA regulations. Data that will be 
extracted from the EMR will not contain any patient identifying 
information. The procedure by which it will be extracted is via CPT code 
records for scleral buckle surgery. De-identified data extracted will be 
stored in a dataset along with arbitrary patient ID within the Vistar Eye 
Center computer network so that it cannot be accessed without both 
physical access and log-in credentials. Access to study materials is granted 
only to 2 surgeons listed on this document (John, McClintock), and the 
research coordinator (Vaidya).  
19.3 For multi-site studies, describe how data or specimens will be handled 
and secured for each site (e.g., central or disseminated data storage, data 
coordinating center). 
19.4 Describe the plan for data disposition following the conclusion of the 
study (e.g., long term maintenance of data, data destruction methods).  
Data will not be stored outside of that needed for medical care after the 
conclusion of the study. Medical information will continue to exist on the 
Electronic Medical Records at Vistar Eye Center, but all extracted data 
will be destroyed 3 years following publication of the results of this study 
as is standard protocol. 
● 
What information will be included in the long term storage of data 
or specimens? 
● 
How long will the data or specimens be stored? 
● 
Where and how data or specimens will be stored? 
● 
Who will have access to the data or specimens during long term 
storage? 
● 
Who is responsible for receipt or transmission of the data or 
specimens? 
● 
How will data or specimens be shared or transported? 
● 
When and how will personal identifiers be destroyed? 
 
20.0 Provisions to Protect the Privacy Interests of Subjects 
20.1 Describe the steps that you will take to protect subjects’ privacy interests. 
“Privacy interest” refers to a person’s desire to place limits on with whom 
they interact or to whom they provide personal information (e.g., 
collecting the minimal amount of private information required to complete 
the study, protecting the data once it is obtained).  
No patient identifying information will be extracted from the electronic 
medical records. The only people with access to this information is the 
medical care team of the patient. De-identified data will not be shared 


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beyond the two surgeons involved in the study design and research 
coordinator. 
20.2 Describe steps that you will take to make subjects feel at ease with the 
research situation in terms of the questions being asked and the 
procedures being performed. “At ease” does not refer to physical 
discomfort, but the sense of intrusiveness a subject might experience in 
response to questions, examinations, and procedures (e.g., use of a same 
gender investigator to place sensors on the torso, a private changing area 
if clothing must be changed, sensitivity when discussing  pregnancy testing 
with subjects, making it clear on surveys that participants can discontinue 
at any time, not asking questions about private or sensitive issues unless 
necessary for the research). 
20.3 Describe how you plan to access existing sources of information about the 
subjects (e.g., medical records, grades) and how you will protect 
participant privacy through the data security plan. 
Data extraction from the medical record will be done by one of the two 
surgeon members of the Vistar Eye Center team who would otherwise 
have access to the medical data anyway for patient care. The procedure by 
which it will be extracted is via CPT code records for scleral buckle 
surgery. De-identified data extracted will be stored in a dataset along with 
arbitrary patient ID within the Vistar Eye Center computer network. 
20.4 Describe any required reporting that might occur as a result of your 
research questions, study populations, and data collection methods. 
Examples for Virginia and Virginia Tech include: 
• Any suspicions (e.g., circumstantial, disclosed) of child abuse (physical, 
emotional, sexual) and neglect  
• Sexual discrimination and/or sexual violence that involves a student 
• Disclosure or signs of intention to harm oneself (i.e., suicidal ideation 
and/or plan) 
• Disclosure or signs of desire to harm others (i.e., homicidal ideation 
and/or plan) 
• Suspected abuse, neglect or exploitation of vulnerable adults (e.g., 
individuals with a disability, elderly persons) 
 
21.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
Safety monitoring is required when research involves greater than minimal risk 
and is sometimes appropriate for other studies. 
21.1 Describe: 
● 
The plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe  (e.g., 
periodic reporting to the IRB, establishing a data monitoring 


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committee, reporting data monitoring committee findings to the IRB 
and the sponsor). 
 
The patient’s IOP will be measured at baseline prior to the surgery, 
as well as 24 hrs post-op and 2 weeks post-op. This is done to 
monitor ocular hypertension, a potential side-effect of both the 
surgery and TA treatment. Patients will also have two normally 
scheduled follow-up visits with the surgeon who will be monitoring 
for any other adverse events such as hypersensitivity or infection. If 
adverse events occur that may be related to the intervention, they 
will be reported to the IRB promptly. The data will also be 
monitored after every 10th patient completes the protocol for any 
statistically significant differences in the primary or secondary safety 
endpoints. If this occurs, it too will be reported to the IRB promptly.  
 
 
22.0 Compensation for Research Related Injury 
22.1 If the research involves more than minimal risk to subjects, describe the 
available compensation in the event of research-related injury, if any. 
n/a 
22.2 Provide a copy of contract language, if any, relevant to compensation for 
research-related injury. At Virginia Tech, this is most common for 
sponsored research. 
n/a 
23.0 Economic Burden to Subjects 
23.1 Describe any costs that subjects might be responsible for because of 
participation in the research, including any uncompensated costs for items 
such as transportation, missed work, and childcare. 
None. The TA irrigation will be done at no extra cost to the patient. 
Patients do not have to make any additional visits. 
24.0 Consent Process 
24.1 Indicate the process by which you will obtain consent for study 
participation. Please upload all consent, parental permission, and assent 
forms, documents, and scripts referenced in this section to Protocol 
Management. 
Describe the following: 
● 
Where the consent process will take place (e.g., clinic waiting area, 
classroom, online) 
 


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The patient will be consented in the clinic patient exam room, 
immediately following consultation with the doctor about the 
planned surgical procedure. The consultation will be done by the 
doctor who is well trained on the procedures and risks. The doctor 
will also be able to answer any more specific questions that the 
patient may have. 
 
● 
The time interval between sharing the consent information with the 
prospective subject and obtaining consent. For lab, interview, and 
focus group studies, the Virginia Tech IRB prefers that subjects have 
at least 24 hours to review the consent form and study information 
before the appointment where consent will be obtained. For simple 
online survey studies, you can typically present the consent 
information immediately before subjects begin participation. 
 
The obtaining of consent will occur directly after the sharing of 
consent information. However, the patient will be given a copy of 
the consent forms and the surgery will not usually take place until 
the next day or longer still, giving the patient sufficient time to 
review the materials and change their decision to withdraw or 
provide consent by notifying any staff member up until the moment 
right before surgery.   
 
● 
If applicable, processes to ensure ongoing consent or assent (e.g., 
for multiple sessions; for research in which a minor will turn 18 
during the study; for longitudinal research with minors who will 
later be asked to provide or affirm their assent). 
 
As there is no more than minimal risk to the patient after the original 
intervention, we do not believe this is necessary. 
● 
Please review “SOP: Informed Consent Process for Research (HRP-
090)” for recommended procedure. Describe your process, being 
sure to include: 
o 
The name and role of all study personnel who will be trained 
and certified by the PI to conduct the consent process 
o Dr. Vishak John M.D. (PI) 
o Dr. Michael McClintock Jr. M.D. 
o Parth Vaidya, Medical Student, Research Coordinator 
o 
The time that will be devoted to the consent discussion 
The consent discussion will be given up to 15 minutes with the 
surgeon if the patient has questions or concerns about the 
study. The patient will also be given the phone number and 
email of the primary research coordinator to contact them with 
any additional questions after they leave. The patient also has 
as much time as they need to review the consent documents 
before the start of the surgery to decide to consent or not to. 


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o 
Steps that you will take to minimize the possibility of coercion 
or undue influence 
o 
The patient will be given a copy of the consent documents and 
allowed to review them at home and change their minds about 
whether they will be consenting to the study up until time of 
surgery. Patients will also be asked teach-back questions to 
ensure adequate understanding as listed in the consent script 
document. 
o 
Steps that you will take to gauge or ensure the subjects’ 
understanding 
o 
Patients will be asked 3 questions to gauge for understanding: 
a. What is the purpose of this study? 
b. What are the risks and benefits to participating? 
c. Are you required to participate in this study? 
25.0 Process to Document Consent in Writing 
25.1 Consult “SOP: Written Documentation of Consent (HRP-091)” for 
recommended procedures, and describe whether and how consent of the 
subject will be documented in writing. 
25.2 If the 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, you can request that the 
IRB waive the requirement to obtain written documentation of consent 
(e.g., consent to participate is indicated by pressing a button for an online 
questionnaire – after the consent information is presented and before the 
questionnaire begins). 
25.3 If you will document consent in writing, attach a consent document with 
places for signatures. If you will obtain consent, but not document consent 
in writing, please attach the consent script or text. Review “CHECKLIST: 
Waiver of Written Documentation of Consent (HRP-411)” to ensure that 
you have provided sufficient information. You should use “TEMPLATE 
CONSENT DOCUMENT (HRP-502)”to create the consent document or 
script. 
 
26.0 Resources Available 
26.1 Describe the resources available to conduct the research. For example, as 
appropriate: 
● 
Describe the PI’s availability to supervise the research 
● 
The study was initiated by the PI (Vishak John) along with the 
research coordinator (Parth Vaidya) and another surgeon (Michael 
McClintock Jr), and the PI will take full responsibility for 
supervising the research. The PI will be fully available to answer any 
and all questions by both research team and patients. The PI will also 


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often be in the same physical location as the surgeons on the 
research team and the patients, ensuring access. 
 
● 
Justify the feasibility of recruiting the required number of suitable 
subjects within the agreed recruitment period. For example, how 
many potential subjects do you have access to? What percentage of 
those potential subjects do you need to recruit? 
● 
There are 4 scleral buckle surgeries done each month between the 4 
surgeons who will be conducting the operations. We would need to 
recruit 50% of them into the study in order to meet the recruitment 
period of 2 years. 
● 
Describe the time that you will devote to conducting and completing 
the research. 
This research project will not take much additional time as the 
majority of the time-consuming procedures are done anyway as 
standard of care. Additional time of 1 hour each week will be 
dedicated to consenting, answering questions, documentation, and 
statistical analysis.  
● 
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 (e.g., training plans, 
detailed study notebooks). 
● 
Each of the 2 surgeons are already well informed about the 
procedures, drugs, and risks involved due to routine retinal surgery 
training. There will be a meeting prior to beginning the study with 
the research coordinator, PI, Dr. McClintock, and all support staff 
that will be collecting the forms to ensure understanding of all 
protocols and procedures.  
27.0 Multi-Site Research 
Contact the HRPP for multi-site research (involving multiple institutions) and 
the details required for this section will be provided. Otherwise, indicate N/A. 
N/A 
 
References: 
 
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[Postoperative pain in retinal detachment surgery]. J Fr Ophtalmol. 2007;30(10):992-
997. 
2.  Damasceno NAP, Damasceno EF, Ventura MP, Vianna RNG. SCLERAL 
BUCKLING SURGERY AND EYE PAIN: Assessment of Chronic Eye Pain During 


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the Postoperative Period of Scleral Buckling Surgery. RETINA. 2014;34(6):1083. 
doi:10.1097/IAE.0000000000000057 
3.  Li Z, Wang Q. Ice compresses aid the reduction of swelling and pain after scleral 
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4.  Couch SM, Bakri SJ. Intravitreal triamcinolone for intraocular inflammation and 
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2016;100(7):949-955. doi:10.1136/bjophthalmol-2015-307347 
6.  Mehta S, Laird P, Debiec M, et al. Formulation of a Peribulbar Block for Prolonged 
Postoperative Pain Management in Vitreoretinal Surgery: A Randomized Clinical 
Trial. Ophthalmol Retina. 2018;2(4):268-275. doi:10.1016/j.oret.2017.07.011 
7.  Massicotte E, Hammamji K, Landry T, Häuser W, Fitzcharles M-A. Postoperative 
Pain Management in Vitreoretinal Surgery for Retinal Detachment: A Systematic 
Review of Randomized Controlled Trials. J Vitreoretin Dis. 2018;2(3):160-175. 
doi:10.1177/2474126418763229 
8.  Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale 
for audit and post-discharge review. BJA Br J Anaesth. 2012;108(3):423-429. 
doi:10.1093/bja/aer505