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The study is collecting data along with other academic institutions regarding the accuracy of ocular ultrasound in diagnosing retinal detachment.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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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
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| Name | Affiliation | Role |
|---|---|---|
| Tze Lyn S Tseeng, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Loma Linda | California | 92354 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 22159380 | 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. | |
| 15448314 |
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shared across other sites that are pooling data across redcap.
February 5, 2018 through March 25, 2018 (approximately 8 weeks)
Participant sites maintaining a study redcap account
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Receiving Ultrasound | Enrolled participants will receive a bedside ocular ultrasound of the affected eye and the ultrasound will be compared with the ophthalmologist diagnosis. The participant's medical record will also be reviewed for information regarding demographics, complications, and outcomes. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Same criteria as participant flow assignment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Receiving Ultrasound | Enrolled participants will receive a bedside ocular ultrasound of the affected eye and the ultrasound will be compared with the ophthalmologist diagnosis. The participant's medical record will also be reviewed for information regarding demographics, complications, and outcomes. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Retinal Detachment Per Ultrasound Assessment | Number of Participants with retinal detachment per ocular ultrasound results | Posted | Count of Participants | Participants | at baseline |
|
at baseline
These subjects are seen on a one time bases in the emergency department and so adverse events, if they are occur, are collected at baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Receiving Ultrasound | Enrolled participants will receive a bedside ocular ultrasound of the affected eye and the ultrasound will be compared with the ophthalmologist diagnosis. The participant's medical record will also be reviewed for information regarding demographics, complications, and outcomes. 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. |
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The info entered reflects one Emergency Department site.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie Tseeng | Loma Linda University Medical Center | 9095584000 | ttseeng@llu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2017 | Sep 21, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 21, 2017 | Sep 21, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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ophthalmologists will be blinded to the ultrasound result and formal ophthalmology assessment will be compared to the ultrasound assessment.
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| 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. |
|
| 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. |
| 4307960 | 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. |
| 24680547 | 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. |
| 12153883 | 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. |
| 19625159 | 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. |
| 20836770 | 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. |
| 24050798 | 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. |
| 12670853 | 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. |
| 16997419 | 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. |
| 18509619 | 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. |
| 18275454 | 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. |
| 25035741 | 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Retinal detachment diagnosis | Subjects diagnosed with retinal detachment or vitreous detachment. | Number | participants |
|
| Units |
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| Counts |
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| Participants |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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