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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106025
Recruitment Status : Unknown
Verified January 2018 by Loma Linda University.
Recruitment status was:  Not yet recruiting
First Posted : April 10, 2017
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

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

Condition or disease Intervention/treatment Phase
Retinal Detachment Device: Ultrasound Not Applicable

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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group 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.
Primary Purpose: Diagnostic
Official Title: Use of Ocular Point of Care Ultrasound in Diagnosing Retinal Detachment in the Emergency Department: A Prospective Study.
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Ocular Ultrasound [ Time Frame: 10 minutes during the patient's visit will be towards obtaining consent and ultrasound evaluation ]
    Ocular ultrasound diagnosis will be compared to formal ophthalmology evaluation diagnosis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106025


Contacts
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Contact: Tze Lyn S Tseeng, MD 3522082267 ttseeng@llu.edu
Contact: Ellen Reibling, PhD 909.558.7407 ext 87407 EReibling@llu.edu

Locations
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United States, California
Loma Linda University Health
Loma Linda, California, United States, 92354
Contact: David Calder, MBA    909-558-7127    dcalder@llu.edu   
Contact: Joanna Lopez    909 558-7171    joalopez@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Tze Lyn S Tseeng, MD Loma Linda University
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.

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Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT03106025    
Other Study ID Numbers: 5170078
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: shared across other sites that are pooling data across redcap.

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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
Additional relevant MeSH terms:
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Retinal Detachment
Emergencies
Dissociative Disorders
Disease Attributes
Pathologic Processes
Mental Disorders
Retinal Diseases
Eye Diseases