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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03106025
Other study ID # 5170078
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 5, 2018
Est. completion date March 25, 2018

Study information

Verified date September 2022
Source Loma Linda University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date March 25, 2018
Est. primary completion date March 25, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ultrasound
Each participant will receive an ocular ultrasound which poses minimal to no harm to the participant and the ultrasound results compared to final diagnosis.
Other:
Ophthalmology Assessment
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.

Locations

Country Name City State
United States Loma Linda University Health Loma Linda California

Sponsors (1)

Lead Sponsor Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View 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. — View 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. — View 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. — View Citation

Geeraerts T, Merceron S, Benhamou D, Vigué 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. — View 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. — View 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. — View Citation

Lizzi FL, Coleman DJ. History of ophthalmic ultrasound. J Ultrasound Med. 2004 Oct;23(10):1255-66. — View 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. — View 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. Epub 2006 Sep 25. — View 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. — View 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. Review. — View 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.

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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Retinal Detachment Per Ultrasound Assessment Number of Participants with retinal detachment per ocular ultrasound results at baseline
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