Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000274370
Ethics application status
Approved
Date submitted
28/05/2008
Date registered
29/05/2008
Date last updated
29/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vein Pulsation Study trial in Glaucoma
Scientific title
Improving the management of glaucoma through better prediction of susceptible patients and improved understanding of surgical success
Universal Trial Number (UTN)
Trial acronym
VPSG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 3197 0
Condition category
Condition code
Eye 3359 3359 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The optic nerve venous pulsation will be measured using an Ophthalmodynamometer which allows the ocular force to be measured at the same time that the back of the eye is being viewed by the examiner. The ophthalmodynamometer allows measurement of the force required to cause the vein and artery within the nerve to pulsate. The study will run for 5 years.
Intervention code [1] 2934 0
Diagnosis / Prognosis
Comparator / control treatment
Force required to collapse retinal veins and arteries converted to perfusion pressure quotient.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4246 0
Detection of glaucoma progression by visual field and optic disk photography
Timepoint [1] 4246 0
5 years
Secondary outcome [1] 7177 0
Detection of glaucoma progression by visual field and optic disk photography
Timepoint [1] 7177 0
1 year
Secondary outcome [2] 7178 0
Detection of glaucoma progression by visual field and optic disk photography
Timepoint [2] 7178 0
3 years

Eligibility
Key inclusion criteria
Glaucoma, open angle, age less than 80
Minimum age
No limit
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Hazy ocular media precluding photography of optic disk

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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 6097 0
6009

Funding & Sponsors
Funding source category [1] 3430 0
Government body
Name [1] 3430 0
National Health and Medical Research Council
Country [1] 3430 0
Australia
Primary sponsor type
Individual
Name
Assoc. Prof. W. H. Mogan
Address
Lions Eye Institute
2 Verdun Street
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 3072 0
Individual
Name [1] 3072 0
Dr. P. H. House
Address [1] 3072 0
Applecross Eye Care
61 Simpson Street
Ardross WA 6153
Country [1] 3072 0
Australia
Other collaborator category [1] 294 0
Individual
Name [1] 294 0
Prof Martin Hazelton
Address [1] 294 0
Department of Statistics
Massey University
Palmerston North
Country [1] 294 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5451 0
University of Western Australia
Ethics committee address [1] 5451 0
HREC, Registrar'sOffice
UWA
35 Stirling Highway
Crawley WA 6009
Ethics committee country [1] 5451 0
Australia
Date submitted for ethics approval [1] 5451 0
Approval date [1] 5451 0
16/10/2006
Ethics approval number [1] 5451 0
RA/4/1571

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

Contacts
Principal investigator
Name 28619 0
Address 28619 0
Country 28619 0
Phone 28619 0
Fax 28619 0
Email 28619 0
Contact person for public queries
Name 11776 0
Rachel Trotter
Address 11776 0
Office of Assoc. Prof. W.H. Morgan
Lions Eye Institute
2 Verdun Street
Nedlands WA 6009
Country 11776 0
Australia
Phone 11776 0
61 8 9381-0873
Fax 11776 0
61 8 9381-0839
Email 11776 0
rtrotter@cyllene.uwa.edu.au
Contact person for scientific queries
Name 2704 0
W.H. Morgan
Address 2704 0
Lions Eye Institute
2 Verdun Street
Nedlands WA 6009
Country 2704 0
Australia
Phone 2704 0
61 8 9381-0873
Fax 2704 0
61 8 9381-0839
Email 2704 0
whmorgan@cyllene.uwa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?



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.