Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000043336
Ethics application status
Approved
Date submitted
22/01/2008
Date registered
29/01/2008
Date last updated
9/11/2018
Date data sharing statement initially provided
9/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Emergency Department ocular ultrasound in patients with acute visual disturbance thought to be due to retino-vitreous pathology
Scientific title
In patients with acute visual disturbance thought to be due to posterior ocular pathology, how does emergency department sonographic diagnosis compare to ophthalmological diagnosis?
Secondary ID [1] 296562 0
nil known
Universal Trial Number (UTN)
Trial acronym
POPES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute visual disturbance 2749 0
Condition category
Condition code
Eye 2875 2875 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ocular ultrasound in the emergency department - using 10MHz linear array transducer scanning in transverse and sagittal planes at lowest power setting giving adequate images, expected duration approx 5 minutes
Intervention code [1] 2488 0
Not applicable
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3759 0
Comparison of emergency ultrasonographic diagnosis with that of formal ophthalmological review
Timepoint [1] 3759 0
Feb 2008 to Feb 2009
Secondary outcome [1] 6351 0
Nil
Timepoint [1] 6351 0
Nil

Eligibility
Key inclusion criteria
Patients presenting to an emergency department with suspected acute retino-vitreous pathology.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
15/02/2008
Actual
15/02/2008
Date of last participant enrolment
Anticipated
Actual
15/02/2010
Date of last data collection
Anticipated
Actual
15/02/2010
Sample size
Target
80
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 744 0
6009

Funding & Sponsors
Funding source category [1] 3001 0
Self funded/Unfunded
Name [1] 3001 0
Country [1] 3001 0
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Hospital Avenue
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 2707 0
None
Name [1] 2707 0
Address [1] 2707 0
Country [1] 2707 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4961 0
Ethics committee address [1] 4961 0
Ethics committee country [1] 4961 0
Date submitted for ethics approval [1] 4961 0
28/01/2008
Approval date [1] 4961 0
30/01/2008
Ethics approval number [1] 4961 0

Summary
Brief summary
The aim of the study is to compare diagnostic accuracy of emergency department ultrasound diagnosis with eventual ophthalmological diagnosis in patients with suspected posterior ocular pathology e.g vitreous haemorrhage, vitreous detachment, retinal detachment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28320 0
Address 28320 0
Country 28320 0
Phone 28320 0
Fax 28320 0
Email 28320 0
Contact person for public queries
Name 11477 0
Antonio Celenza
Address 11477 0
Level 2, R Block
QE II Medical Centre
Nedlands, WA 6009
Country 11477 0
Australia
Phone 11477 0
08 9346 4355
Fax 11477 0
Email 11477 0
tony.celenza@uwa.edu.au
Contact person for scientific queries
Name 2405 0
Antonio Celenza
Address 2405 0
Level 2, R Block
QE II Medical Centre
Nedlands, WA 6009
Country 2405 0
Australia
Phone 2405 0
08 9346 4355
Fax 2405 0
Email 2405 0
tony.celenza@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.