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

September 23, 2022 updated by: Tze Lyn Stephanie Tseeng, Loma Linda University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients Receiving 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.
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.
Experimental: Ocular 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Retinal Detachment Per Ultrasound Assessment
Time Frame: at baseline
Number of Participants with retinal detachment per ocular ultrasound results
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Tze Lyn S Tseeng, MD, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2018

Primary Completion (Actual)

March 25, 2018

Study Completion (Actual)

March 25, 2018

Study Registration Dates

First Submitted

April 4, 2017

First Submitted That Met QC Criteria

April 4, 2017

First Posted (Actual)

April 10, 2017

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

September 23, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5170078

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

shared across other sites that are pooling data across redcap.

IPD Sharing Time Frame

February 5, 2018 through March 25, 2018 (approximately 8 weeks)

IPD Sharing Access Criteria

Participant sites maintaining a study redcap account

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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