Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000325202
Ethics application status
Approved
Date submitted
26/04/2009
Date registered
21/05/2009
Date last updated
21/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study for the development of new non-invasive methods for monitoring intracranial pressure using observation of the ocular retinal veins and optic disk.
Scientific title
Study for the development of new non-invasive methods for monitoring intracranial pressure using observation of the ocular retinal veins and optic disk.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Raised intracranial pressure 4667 0
Condition category
Condition code
Neurological 4973 4973 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects who have invasive intracranial pressure monitors in place will have recordings of central retinal vein pulsation pressure by ophthalmodynomometry 4 times over 24 hours.
Intervention code [1] 4433 0
Diagnosis / Prognosis
Comparator / control treatment
central retinal vein pulsation pressure will be compared to intracranial pressure measurement.This will be done 4 times over 24 hours. The central retinal vein pulsation pressure will be ascertained by ophthalmodynomometry.
Control group
Active

Outcomes
Primary outcome [1] 5823 0
central retinal vein pulsation pressure by ophthalmodynomometry
Timepoint [1] 5823 0
over 24 hours during admission. 4 measurements.
Secondary outcome [1] 241824 0
nil
Timepoint [1] 241824 0
nil

Eligibility
Key inclusion criteria
subjects who have intracranial pressure monitors in place who are conscious and able to provide informed consent.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
subjects who cannot sit up.
subjects who cannot tolerate mydriatic eye drops.

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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4852 0
Self funded/Unfunded
Name [1] 4852 0
Sam Kain
Country [1] 4852 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles gairdner Hospital
Address
1 hospital Ave
Nedlands
Perth
Western Australia 6009
Country
Australia
Secondary sponsor category [1] 4389 0
None
Name [1] 4389 0
nil
Address [1] 4389 0
nil
Country [1] 4389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6909 0
Sir Charles Gairdner Hospital Ethics Committee
Ethics committee address [1] 6909 0
Ethics committee country [1] 6909 0
Australia
Date submitted for ethics approval [1] 6909 0
Approval date [1] 6909 0
20/04/2009
Ethics approval number [1] 6909 0
2009-024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29535 0
Address 29535 0
Country 29535 0
Phone 29535 0
Fax 29535 0
Email 29535 0
Contact person for public queries
Name 12782 0
WH Morgan
Address 12782 0
Lions Eye Institute
2 Verdun St
Nedlands 6009
Western Australia
Country 12782 0
Australia
Phone 12782 0
+61893810873
Fax 12782 0
Email 12782 0
[email protected]
Contact person for scientific queries
Name 3710 0
WH Morgan
Address 3710 0
2 Verdun St
Nedlands
Western Australia 6009
Country 3710 0
Australia
Phone 3710 0
+61893810873
Fax 3710 0
Email 3710 0
[email protected]

No information has been provided regarding IPD availability


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.