Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in the Emergency Department: A Prospective Study.
Phase: NA
Conditions: Retinal Detachment
Sponsor: Loma Linda University

 
 
 
 
Use of Ocular Point of Care Ultrasound in Diagnosing 
Retinal Detachment in the Emergency Department: A 
Prospective Study. 
 
NCT# 5170078 
 
Document Date: August 21, 2017 

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1. 
PROTOCOL INFORMATION  
Title: Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in 
the Emergency Department: A Prospective Study.  
Funding Source: Emergency Medicine  
Phase of Study: initial  
Version Date of Protocol: version 1 
 
2. 
PRINCIPAL INVESTIGATOR’S INFORMATION 
PI Name: Tze Lyn Stephanie Tseeng, MD 
Assistant Professor, Attending Physician Loma Linda Emergency Department 
Loma Linda University Health Center 
11234 Anderson St 
Loma Linda, CA 92354 
ttseeng@llu.edu 
 
3. 
STUDY PERSONNEL 
Patients will be enrolled and data will be collected by an IRB trained Loma Linda 
emergency medicine advanced practice provider or physicians and Loma Linda 
student research assistants 
 
4. 
STUDY INFORMATION 
Location(s) of Research Activity: Loma Linda Emergency Department  
Expected Start/Stop Dates of Research:July 2017-July 2018  
Type of Research: Other- Ultrasound diagnostic 
 
5. 
INCLUSION / EXCLUSION CRITERIA 
Inclusion criteria: Participants may include any patient that is greater than 18 years 
old with any complaint of vision loss, flashers, floaters and/or any other patient 
whom the emergency physician feels requires an evaluation for mac on retinal 
detachment, mac off retinal detachment, vitreous hemorrhage, and or vitreous 
detachment. Patients that meet this eligibility criterion must also be receiving a 
consult by a LLU ophthalmology physician in order to obtain comparative time 
values and accuracy for ED physician diagnosis versus ophthalmologist diagnosis.  
 
Exclusion criteria: Exclusion Criteria includes any ocular trauma, any concern for 
ruptured globe, or any other extraneous reason determined by the treating ED 
physician. Excluded patients also include: pregnant women, patients < 18 years of 
age, and patients not receiving an ophthalmology consult. We will be excluding 
pregnant women in order to minimize the exposure to ultrasonography for expectant 

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mothers. We will be excluding patients <18 years of age because it is unlikely that the 
data from these patients will significantly contribute to our investigation.   
 
6. 
SUBJECT RECRUITMENT & SCREENING 
Number of Subjects: estimated 250-300 across all sites in conjunction with USC, 
UCI, UCLA 
Subject Age Range: 18+ 
Subject Gender: males and females both  
Racial/Ethnic Distribution: any  
Target Study Population: Adults non pregnant patients with painless vision loss 
Recruitment Method Info: Potential patients will be identified by screening the ED 
tracking board and by asking physicians working in the department if they have any 
patients who will be evaluated for a possible retinal detachment. 
 
7. 
INFORMED CONSENT PROCESS 
The study will take place in the Emergency Department of LLUMC. The patient study 
population will include adult patients presenting to the emergency department with 
ocular complaints that lead to a physician’s suspicion of retinal detachment. A 
treating attending physician or resident will evaluate the patient as per standard of 
care.  If there is a concern for retinal detachment, the treating physician will order an 
ophthalmology consult. 
IRB trained resident physicians  or attending physicians of the Loma Linda 
emergency department will identify and approach patients regarding the study and 
obtain a signed informed consent if the patient agrees to participate. No medical 
records will need to be accessed for the purposes of this screening. If the patient 
declines to be enrolled in the study, treatment will proceed as per standard of care 
determined by the treating physician. In the cases where the physician treating the 
patient approaches the patient about being enrolled in this study, it will be made 
clear to the patient that his/her decision to be enrolled or not will in no way affect 
their quality of care in the ED by that physician.  Only patients who require an 
ophthalmology consult to diagnose retinal detachment, as part of their normal ED 
care, will be enrolled.  No x-rays, CTs, or formal ultrasounds will be performed 
solely for the purpose of this study.  If a patient agrees to be enrolled in the study, 
he/she will sign a written informed consent form and a HIPAA form prior to the 
ultrasound procedure being performed.  
The time of ophthalmology consult will be recorded. Next an emergency department 
physician will perform the ocular ultrasound and make a diagnosis based upon their 
findings. Images will be archived and stored in a locked hard drive stored in a locked 
office. Agreeing to participate will allow the study team to collect data from the 
ultrasound exam and authorize access to the subject’s medical record for the 
purposes of research only. Information accessed from the medical record includes the 
duration of symptoms, height and weight, age, and the outcomes of standard testing. 
The final discharge diagnosis from the ophthalmology consult will be reviewed as 
well. 
 
8. 
STUDY DESIGN 
a. Background or rationale for this study: This is a prospective, cross-sectional 
study to assess the utility of Point of Care Ultrasound (POCUS) in the diagnosis 
of ocular complaints in the emergency department with specific focus on the 
accuracy of diagnosis when compared to that of a blinded ophthalmologist. 
Ocular complaints represent between 2% and 3% of ED visits (Walker et al, 
2011). This percentage may include vision-threatening diagnoses including 

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retinal detachment, which can occur in 3-4% of patients presenting with ocular 
complaints (Alotaibi et al, 2011). However, the equipment and expertise 
required to adequately assess for conditions such as retinal detachment are 
limited in busy EDs due to the time consuming and challenging nature of the 
examination. Incorporating the use of an ultrasound could provide a more 
available, focused, and timely assessment.  
b. Objectives. To determine the accuracy of ocular ultrasound in diagnosing retinal 
detachment compared to gold standard of ophthalmology examination.  
c. Procedures involved (Research Interventions): Ocular Ultrasound 
d. Alternative procedures, if any, that are not included in the study but might be 
advantageous to the subject. none 
e. If any deception is required for validity of this study, explain why this is 
necessary and how subject(s) will be debriefed. n/a 
f. Concise review of literature that supports the rationale, objectives, and 
methodology of the proposed study: Ocular POCUS has been utilized by 
ophthalmologists for decades and has been described as a tool for identifying 
retinal detachment since 1969 (Lizzi et al, 2004; Coleman et al, 1969; Vrablik 
et al, 2014). The ophthalmology team at LLU Medical Center evaluates patients 
using a focused ocular exam with a fundoscope and ocular dilation. The 
emergency department team has access to one fundoscope for ocular 
examination; incorporating the use of an ultrasound could provide a more 
available, focused, and timely assessment. A recently published meta-analysis 
identified only 3 small prospective trials in the Emergency Department that 
were determined to be at low risk of bias (Vrablik, 2014). The first study 
conducted by Blaivas et al in 2002 demonstrated an impressive 100% sensitivity 
and 100% specificity of ocular POCUS identification of retinal detachment in 
61 subjects. In this study all attending physicians and residents received only 1 
hour of hands-on instruction and 1 hour of lecture prior to study participation 
(Blaivas et al, 2002).  A second study conducted in 2010 by Yoonessi et al 
demonstrated a sensitivity of 100% and specificity of 83% in detecting retinal 
detachment by ocular POCUS in 48 subjects after only a 20-minute ocular 
ultrasound lecture (Yoonessi et al, 2010). Shinar et al conducted the final study 
in 2011, which demonstrated a sensitivity of 97% and specificity of 92% in 
detecting retinal detachment by ocular POCUS in 92 subjects (Shinar et al., 
2011). These studies suggest that ocular POCUS is an accurate diagnostic tool 
for identifying retinal detachment in the ED and may require minimal ED 
physician training. However, these studies are limited in their sample size. We 
intend to expand upon this prior research by enrolling more patients in addition 
to comparing the accuracy of ocular POCUS diagnosis to a blinded 
ophthalmologist. In secondary outcome measures we will compare the overall 
time to diagnosis of the Emergency Physician performing ocular POCUS to the 
time to diagnosis of the consulting ophthalmologist. Many additional studies 
have identified multiple other diagnostic utilities for ocular ultrasound. While 
accurate assessment of the optic disc can provide critical information regarding 
the patient’s intracranial pressure, and be invaluable in diagnosis and 
treatment for patients, an accurate evaluation by fundoscopic examination is 
challenging at best and often impossible for those without specific expertise. 
Utilizing ultrasound to assess both retrobulbar optic nerve sheath and optic disc 
swelling as an indicator of increased intracranial pressure may prove as an 

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accurate alternative. This may lead to earlier ED detection of increased 
intracranial pressure that may be caused by a variety of pathologies including 
inflammatory diseases, infection, infiltrative conditions, and microvascular 
infarction, such as occurs with malignant hypertension (Blaivas, 2003; Tayal et 
al, 2007; Kimberly et al, 2008; Geeraerts et al, 2008, Teismann et al, 2013).  
Other case reports recently suggest the potential utilization of ultrasound to 
identify optic neuritis and as risk stratification for identifying orbital cellulitis 
(Kang et al, 2014). Therefore, continuing to expand the research of ocular 
POCUS in the ED could lead to a multitude of uses for the evaluation of ocular 
complaints that may improve the accuracy and speed to diagnosis at a lower 
cost with a non-invasive diagnostic tool.  
 
9. 
DATA COLLECTION 
 
Potential study subjects will be identified by participating researchers by a complaint 
of painless vision loss and treating physician’s clinical suspicion of retinal 
detachment for which an ophthalmology consult is ordered. If a patient meets criteria 
for the study, then a research team member will approach each patient who meets 
criteria for possible enrollment.  The patient will be given a Consent Form to read 
and any questions answered by the enrolling and/or treating physician. If he or she 
agrees to participate in the study, the patient will sign a HIPAA Authorization Form 
and Consent Form prior to enrollment. The emergency physician will evaluate the 
patient as per standard of care. Inclusive criteria for this study denotes that patients 
must be receiving an ophthalmology consult as per standard of care. The time of 
ophthalmology consult will be recorded. The ocular point of care ultrasound will then 
be performed on the patient while a research team member (including research 
assistant students) records required information on a data collection form. The 
ultrasound that will be performed will be for research purposes in the majority of 
cases. The treating physician may perform an ocular ultrasound on the patient as 
part of the treatment plan, per physician preference. In this case, the patient will still 
need to consent to the use of their ultrasound data for research. The physician 
performing the ultrasound will place the probe over the patient's closed eye. The 
physician will perform two exams, a static exam and a kinetic exam. In the static 
exam the physician will as the patient to keep their eyes forward while they scan 
longitudinal and transverse in long and short axis (all in normal gain). Then for the 
kinetic exam, the physician will use normal gain to visualize the ocular nerve in 
longitudinal axis, then the physician will over gain for the same visualization. The 
PHI recorded will be the medical record number, name of the patient, and date and 
time of treatment. Only the lead researcher and co-researchers will have access to 
the medical record number for reviewing ultrasound reports and disposition reports, 
as indicated on the attached Data Collection Sheet. The final diagnosis of the 
ophthalmologist will be accessed through the use of the medical record number. The 
time it was entered in the chart will be used as the time parameter for which we use 
as the ophthalmologist consult time. Patient privacy will be protected during this 
study as the patient information will be coded and replaced with a study number that 
will be used during the study. This information will be kept in a locked area and 
separate from the study files, only authorized members of the study team will have 
access to patient identifiable data. Subject identifiable information will be destroyed 
once the data is no longer needed. Regarding training, ED residents will receive 
supplemental lecture and hands-on training in ocular ultrasound. The purpose of this 
supplemental training will be to familiarize residents with performing an ocular 
ultrasound. The training itself will not be evaluated in practice for research purposes. 

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Only the lead researcher and co-researchers will be using the medical record number 
for accessing patient information and reports. 
 
10. LABELING & STORAGE OF DATA & SPECIMENS 
Patient’s private health information will be kept confidential and enrollment in the 
study will include a patient study number. The master patient identification key will 
be kept in a locked office accessible only to researchers. Patient’s ultrasound images 
will be stored on a password encrypted drive which will be locked in an office 
accessible only by Lead Researcher.  
 
11. DATA ANALYSIS 
The data will be screened for normality, missing data, outliers, and skewness.  
Descriptive statistics will be conducted on the data, including all study related 
variables.  Correlation matrices and path analyses will be presented to examine the 
mediating role. Effect sizes for all of these statistics will be reported to establish 
practical significance. 
 
12. RISK AND INJURY 
Patients deemed eligible for the study will be subjected to bedside ocular ultrasound 
via modalities described above, which require specific movements of the ultrasound 
probe as well as changing settings on the machine itself. As such, patients will only 
be exposed to ultrasound gel and ultrasound probes emitting high-frequency sound 
waves, which poses a minimal risk of infection, no radiation exposure, and is 
generally well-tolerated by patients. Patients will have a small plastic patch known as 
a Tegaderm applied to their closed eyelid prior to application of ultrasound gel, to 
further reduce the very low risk of infection or irritation from the gel. This is routine 
practice and is well tolerated by patients. At any point, study subjects may decide to 
refuse consent for the study. 
 
13. BENEFIT(S) 
Patients will not be personally compensated but the performance of ultrasound may 
aid in diagnosis of ocular complaints or identification of ocular pathology. 
 
14. COMPENSATION 
There will be no compensation for patients or researchers.  
 
15. CONFIDENTIALITY 
Patient privacy will be protected during this study as the patient information will be 
coded and replaced with a study number that will be used during the study. This 
information will be kept in a locked area and separate from the study files, only 
authorized members of the study team will have access to patient identifiable data. 
The patient’s images will be held on a password encrypted external hard drive which 
will be stored in a locked office.  
 
16.  
LITERATURE REVIEW 
1. Walker RA, Adhikari S. Chapter 236 p1517-1549. Eye Emergencies. In: Tintinali JE, 
Kelen GD, Stapczynski JS, eds. Tintinali's Emergency Medicine: A Comprehensive 
Study Guide. 7th ed. New York: McGraw-Hill; 2011.  
2.  Alotaibi AG, Osman EA, Allam KH, et al. One month outcome of ocular related 
emergencies in a tertiary hospital in central Saudi Arabia. Saudi Med J. 2011;32:1256-
1260. 

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3.  Lizzi FL, Coleman DJ. History of ophthalmic ultrasound. J Ultrasound Med. 
2004;23:1255-1266. 
4.  Coleman DJ, Konig WF, Katz L. A hand-operated, ultrasound scan system for 
ophthalmic evaluation. Am J Ophthalmol.1969;68:256-263 
5.  Michael E. Vrablik, DO; Gregory R. Snead, MD; Hal J. Minnigan, MD, PhD; Jonathan 
M. Kirschner, MD; Thomas W. Emmett, MD, MLS; Rawle A. Seupaul, MD.The 
Diagnostic Accuracy of Bedside Ocular Ultrasonography for the Diagnosis of Retinal 
Detachment: A Systematic Review and Meta-analysis. Annals of Emergency Medicine 
(2014)  
6.  Blaivas M, Theodoro D, Sierzenski PR. A study of bedside ocular ultrasonography in the 
emergency department. Acad Emerg Med. 2002;9:791-799. 
7.  Shinar Z, Chan L, Orlinsky M. Use of ocular ultrasound for the evaluation of retinal 
detachment. J Emerg Med. 2011;40:53-57. 
8.  Yoonessi R, Hussain A, Jang TB. Bedside ocular ultrasound for the detection of retinal 
detachment in the emergency department. Acad Emerg Med. 2010;17:913-917. 
9.  Teismann, N, Lenagham, P, Nolan, R, Stein, J, Green, A. Point-of-care Ocular 
Ultrasound to DetectOptic Disc Swelling. Academic Emergency Medicine. September 
2013.  
10. Blaivas M, Theodoro D, Sierzenski PR. Elevated intracranial pressure detected by 
bedside emergency ultrasonography of the optic nerve sheath. Acad Emerg Med. 2003; 
10:376–81.  
11.  Tayal VS, Neulander M, Norton HJ, Foster T, Saunders T, Blaivas M. Emergency 
department sonographic measurement of optic nerve sheath diameter to detect findings 
of increased intracranial pressure in adult head injury patients. Ann Emerg Med. 2007; 
49:508–14.  
12.  Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter 
with direct measurement of intracranial pressure. Acad Emerg Med. 2008; 15:201–4.  
13.  Geeraerts T, Merceron S, Benhamou D, Vigu_e B, Duranteau J. Non-invasive 
assessment of intracranial pressure using ocular sonography in neurocritical care 
patients. Intensive Care Med. 2008; 34:2062–7.  
14.  Kang, T, Seif, D, Chilstrom, M, Mailhot, T; Ocular Ultrasound Identifies Early Orbital 
Cellulitis. Western Journal of Emergency Medicine (2014)