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

NCT03106025 | Completed Results DMC FDA Device

• 1 other identifier: 5170078
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The study is collecting data along with other academic institutions regarding the accuracy of ocular ultrasound in diagnosing retinal detachment.

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Retinal Detachment Per Ultrasound Assessment

  Number of Participants with retinal detachment per ocular ultrasound results

  at baseline

Study Arms (2)

Patients Receiving Ophthalmology Assessment

ACTIVE COMPARATOR

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.

Device: Ultrasound; Other: Ophthalmology Assessment

Ocular Ultrasound

EXPERIMENTAL

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

Device: Ultrasound; Other: Ophthalmology Assessment

Interventions

Ultrasound DEVICE

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

Ocular Ultrasound; Patients Receiving Ophthalmology Assessment

Ophthalmology Assessment OTHER

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.

Ocular Ultrasound; Patients Receiving Ophthalmology Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Related Publications (14)

• 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.

  BACKGROUND

• 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.

  PMID: 22159380 BACKGROUND

• 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.

  PMID: 15448314 BACKGROUND

• 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.

  PMID: 4307960 BACKGROUND

• 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.

  PMID: 24680547 BACKGROUND

• 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.

  PMID: 12153883 BACKGROUND

• 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.

  PMID: 19625159 BACKGROUND

• 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.

  PMID: 20836770 BACKGROUND

• 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.

  PMID: 24050798 BACKGROUND

• 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.

  PMID: 12670853 BACKGROUND

• 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.

  PMID: 16997419 BACKGROUND

• 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.

  PMID: 18509619 BACKGROUND

• 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.

  PMID: 18275454 BACKGROUND

• 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.

  PMID: 25035741 BACKGROUND

MeSH Terms

Conditions

Retinal Detachment

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and Caveats

The info entered reflects one Emergency Department site.

Results Point of Contact

• Title: Dr. Stephanie Tseeng
• Organization: Loma Linda University Medical Center

ttseeng@llu.edu

9095584000

Study Officials

• Tze Lyn S Tseeng, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: ophthalmologists will be blinded to the ultrasound result and formal ophthalmology assessment will be compared to the ultrasound assessment.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Medicine Specialist

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: February 5, 2018
• Primary Completion: March 25, 2018
• Study Completion: March 25, 2018
• Last Updated: October 18, 2022
• Results First Posted: October 18, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: February 5, 2018 through March 25, 2018 (approximately 8 weeks)
• Access Criteria: Participant sites maintaining a study redcap account

Locations

US (1)