search
Back to results

Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in the Emergency Department (RDOcularUS)

Primary Purpose

Retinal Detachment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Ophthalmology Assessment
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Retinal Detachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical suspicion for retinal detachment Age >18 years of age Ophthalmology Consult

Exclusion Criteria:

Concurrent ocular trauma Ruptured globe Pregnancy < 18 years of age No ophthalmology consult

Sites / Locations

  • Loma Linda University Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Patients Receiving Ophthalmology Assessment

Ocular Ultrasound

Arm Description

Number of subjects with retinal detachment per formal ophthalmology assessment. This assessment is a composite measurement which includes the following chief complain, primary impression, right visual acuity, left visual, acuity, ultrasound diagnosis, diagnosis changed, ophthalmology diagnosis.

Each participant will receive an ocular ultrasound which poses minimal to no harm to the participant and the ultrasound results compared to final diagnosis

Outcomes

Primary Outcome Measures

Number of Participants With Retinal Detachment Per Ultrasound Assessment
Number of Participants with retinal detachment per ocular ultrasound results

Secondary Outcome Measures

Full Information

First Posted
April 4, 2017
Last Updated
September 23, 2022
Sponsor
Loma Linda University
search

1. Study Identification

Unique Protocol Identification Number
NCT03106025
Brief Title
Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in the Emergency Department
Acronym
RDOcularUS
Official Title
Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in the Emergency Department: A Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
March 25, 2018 (Actual)
Study Completion Date
March 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is collecting data along with other academic institutions regarding the accuracy of ocular ultrasound in diagnosing retinal detachment.
Detailed Description
This is a prospective, cross-sectional study to assess the utility of point of care ultrasound in the diagnosis of ocular complaints in the emergency department (ED) 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 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 emergency departments 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Masking Description
ophthalmologists will be blinded to the ultrasound result and formal ophthalmology assessment will be compared to the ultrasound assessment.
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients Receiving Ophthalmology Assessment
Arm Type
Active Comparator
Arm Description
Number of subjects with retinal detachment per formal ophthalmology assessment. This assessment is a composite measurement which includes the following chief complain, primary impression, right visual acuity, left visual, acuity, ultrasound diagnosis, diagnosis changed, ophthalmology diagnosis.
Arm Title
Ocular Ultrasound
Arm Type
Experimental
Arm Description
Each participant will receive an ocular ultrasound which poses minimal to no harm to the participant and the ultrasound results compared to final diagnosis
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Each participant will receive an ocular ultrasound which poses minimal to no harm to the participant and the ultrasound results compared to final diagnosis.
Intervention Type
Other
Intervention Name(s)
Ophthalmology Assessment
Intervention Description
Number of subjects with retinal detachment per formal ophthalmology assessment. This assessment is a composite measurement which includes the following chief complain, primary impression, right visual acuity, left visual, acuity, ultrasound diagnosis, diagnosis changed, ophthalmology diagnosis.
Primary Outcome Measure Information:
Title
Number of Participants With Retinal Detachment Per Ultrasound Assessment
Description
Number of Participants with retinal detachment per ocular ultrasound results
Time Frame
at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical suspicion for retinal detachment Age >18 years of age Ophthalmology Consult Exclusion Criteria: Concurrent ocular trauma Ruptured globe Pregnancy < 18 years of age No ophthalmology consult
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tze Lyn S Tseeng, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
shared across other sites that are pooling data across redcap.
IPD Sharing Time Frame
February 5, 2018 through March 25, 2018 (approximately 8 weeks)
IPD Sharing Access Criteria
Participant sites maintaining a study redcap account
Citations:
Citation
Walker RA, Adhikari S. Chapter 236 p1517-1549. Eye Emergencies. In: Tintinali JE, Kelen GD, Stapczynski JS, eds. Tintinalli's Emergency Medicine: A Comprehensive Study Guide. 7th ed. New York: McGraw-Hill; 2011.
Results Reference
background
PubMed Identifier
22159380
Citation
Alotaibi AG, Osman EA, Allam KH, Abdel-Rahim AM, Abu-Amero KK. One month outcome of ocular related emergencies in a tertiary hospital in Central Saudi Arabia. Saudi Med J. 2011 Dec;32(12):1256-60.
Results Reference
background
PubMed Identifier
15448314
Citation
Lizzi FL, Coleman DJ. History of ophthalmic ultrasound. J Ultrasound Med. 2004 Oct;23(10):1255-66. doi: 10.7863/jum.2004.23.10.1255. No abstract available.
Results Reference
background
PubMed Identifier
4307960
Citation
Coleman DJ, Konig WF, Katz L. A hand-operated, ultrasound scan system for ophthalmic evaluation. Am J Ophthalmol. 1969 Aug;68(2):256-63. doi: 10.1016/0002-9394(69)94068-9. No abstract available.
Results Reference
background
PubMed Identifier
24680547
Citation
Vrablik ME, Snead GR, Minnigan HJ, Kirschner JM, Emmett TW, Seupaul RA. The diagnostic accuracy of bedside ocular ultrasonography for the diagnosis of retinal detachment: a systematic review and meta-analysis. Ann Emerg Med. 2015 Feb;65(2):199-203.e1. doi: 10.1016/j.annemergmed.2014.02.020. Epub 2014 Mar 27.
Results Reference
background
PubMed Identifier
12153883
Citation
Blaivas M, Theodoro D, Sierzenski PR. A study of bedside ocular ultrasonography in the emergency department. Acad Emerg Med. 2002 Aug;9(8):791-9. doi: 10.1111/j.1553-2712.2002.tb02166.x.
Results Reference
background
PubMed Identifier
19625159
Citation
Shinar Z, Chan L, Orlinsky M. Use of ocular ultrasound for the evaluation of retinal detachment. J Emerg Med. 2011 Jan;40(1):53-7. doi: 10.1016/j.jemermed.2009.06.001. Epub 2009 Jul 21.
Results Reference
background
PubMed Identifier
20836770
Citation
Yoonessi R, Hussain A, Jang TB. Bedside ocular ultrasound for the detection of retinal detachment in the emergency department. Acad Emerg Med. 2010 Sep;17(9):913-7. doi: 10.1111/j.1553-2712.2010.00809.x.
Results Reference
background
PubMed Identifier
24050798
Citation
Teismann N, Lenaghan P, Nolan R, Stein J, Green A. Point-of-care ocular ultrasound to detect optic disc swelling. Acad Emerg Med. 2013 Sep;20(9):920-5. doi: 10.1111/acem.12206.
Results Reference
background
PubMed Identifier
12670853
Citation
Blaivas M, Theodoro D, Sierzenski PR. Elevated intracranial pressure detected by bedside emergency ultrasonography of the optic nerve sheath. Acad Emerg Med. 2003 Apr;10(4):376-81. doi: 10.1111/j.1553-2712.2003.tb01352.x.
Results Reference
background
PubMed Identifier
16997419
Citation
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 Apr;49(4):508-14. doi: 10.1016/j.annemergmed.2006.06.040. Epub 2006 Sep 25.
Results Reference
background
PubMed Identifier
18509619
Citation
Geeraerts T, Merceron S, Benhamou D, Vigue B, Duranteau J. Non-invasive assessment of intracranial pressure using ocular sonography in neurocritical care patients. Intensive Care Med. 2008 Nov;34(11):2062-7. doi: 10.1007/s00134-008-1149-x. Epub 2008 May 29.
Results Reference
background
PubMed Identifier
18275454
Citation
Kimberly HH, Shah S, Marill K, Noble V. Correlation of optic nerve sheath diameter with direct measurement of intracranial pressure. Acad Emerg Med. 2008 Feb;15(2):201-4. doi: 10.1111/j.1553-2712.2007.00031.x.
Results Reference
background
PubMed Identifier
25035741
Citation
Kang TL, Seif D, Chilstrom M, Mailhot T. Ocular ultrasound identifies early orbital cellulitis. West J Emerg Med. 2014 Jul;15(4):394. doi: 10.5811/westjem.2014.4.22007. No abstract available.
Results Reference
background

Learn more about this trial

Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in the Emergency Department

We'll reach out to this number within 24 hrs