Retinal DetachmentRDOcularUSNCT03106025
Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in the Emergency Department
A study testing Ultrasound and Ophthalmology Assessment in people with Retinal Detachment, run by Loma Linda University at 1 site in United States.
Trial summary
The study is collecting data along with other academic institutions regarding the accuracy of ocular ultrasound in diagnosing retinal detachment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Ultrasound and Ophthalmology Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 25 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical suspicion for retinal detachment Age >18 years of age Ophthalmology Consult
Who cannot join
- Concurrent ocular trauma Ruptured globe Pregnancy < 18 years of age No ophthalmology consult
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92354
About this study
Official title: Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in the Emergency Department: A Prospective Study.
The study is collecting data along with other academic institutions regarding the accuracy of ocular ultrasound in diagnosing retinal detachment.
Read the 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.
- Conditions
- Retinal Detachment
- Being tested
- Ultrasound, Ophthalmology Assessment
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Each participant will receive an ocular ultrasound which poses minimal to no harm to the participant and the ultrasound results compared to final diagnosis.
Ophthalmology AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Ultrasound; Other: Ophthalmology Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Retinal Detachment Per Ultrasound Assessment
Number of Participants with retinal detachment per ocular ultrasound results
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start5 Feb 2018
- Primary completion25 Mar 2018
- Study completion25 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tze Lyn Stephanie Tseeng, Loma Linda University
- Investigators
- Tze Lyn S Tseeng, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106025
- Sponsor's protocol ID
- 5170078
- Acronym
- RDOcularUS
- Status last verified
- Sep 2022
- First submitted
- 4 Apr 2017
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: shared across other sites that are pooling data across redcap.
Publications
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.
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.
PubMed 22159380Lizzi 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.
PubMed 15448314Coleman 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.
PubMed 4307960Vrablik 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.
PubMed 24680547Blaivas 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.
PubMed 12153883Shinar 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.
PubMed 19625159Yoonessi 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.
PubMed 20836770Teismann 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.
PubMed 24050798Blaivas 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.
PubMed 12670853Tayal 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.
PubMed 16997419Geeraerts 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.
PubMed 18509619Kimberly 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.
PubMed 18275454Kang 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.
PubMed 25035741
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in the Emergency Department: A Prospective Study.
- ClinicalTrials.gov ID
- NCT03106025
- Acronym / sponsor ID
- RDOcularUS / 5170078
- Conditions
- Retinal Detachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 25 Mar 2018 (actual)
- Study completion
- 25 Mar 2018 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Posted 18 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Ophthalmology Assessment | Active comparator | Device: Ultrasound, Other: Ophthalmology AssessmentNumber 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 | Device: Ultrasound, Other: Ophthalmology AssessmentEach participant will receive an ocular ultrasound which poses minimal to no harm to the participant and the ultrasound results compared to final diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical suspicion for retinal detachment Age >18 years of age Ophthalmology Consult
Key exclusion criteria (1 listed)
- Concurrent ocular trauma Ruptured globe Pregnancy < 18 years of age No ophthalmology consult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundEach participant will receive an ocular ultrasound which poses minimal to no harm to the participant and the ultrasound results compared to final diagnosis. | Device | Ocular Ultrasound, Patients Receiving Ophthalmology Assessment |
| Ophthalmology AssessmentNumber 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. | Other | Ocular Ultrasound, Patients Receiving Ophthalmology Assessment |
Primary outcome
Number of Participants With Retinal Detachment Per Ultrasound Assessment
Time frame: at baseline
Number of Participants with retinal detachment per ocular ultrasound results
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundWalker 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: PubMed 22159380Alotaibi 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.
- Background: PubMed 15448314Lizzi 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.
- Background: PubMed 4307960Coleman 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.
- Background: PubMed 24680547Vrablik 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.
- Background: PubMed 12153883Blaivas 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.
- Background: PubMed 19625159Shinar 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.
- Background: PubMed 20836770Yoonessi 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.
- Background: PubMed 24050798Teismann 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.
- Background: PubMed 12670853Blaivas 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.
- Background: PubMed 16997419Tayal 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.
- Background: PubMed 18509619Geeraerts 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.
- Individual participant dataSharing planned: Yes. shared across other sites that are pooling data across redcap.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tze Lyn S Tseeng, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and Ophthalmology Assessment in people with Retinal Detachment, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Retinal Detachment Per Ultrasound Assessment (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03106025, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.