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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00328835




Registration number
NCT00328835
Ethics application status
Date submitted
18/05/2006
Date registered
22/05/2006
Date last updated
17/10/2006

Titles & IDs
Public title
Optic Nerve Compliance Study
Scientific title
Optic Nerve Compliance Study
Secondary ID [1] 0 0
ONCS
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Brief Elevation of IOP

Treatment: Surgery: Brief Elevation of IOP
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Optic Disc Change
Timepoint [1] 0 0
Primary outcome [2] 0 0
Visual Field Progression
Timepoint [2] 0 0
Secondary outcome [1] 0 0
Visual Acuity Change
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Age over 18, Diagnosis of glaucoma (visual field proven), Stable, well controlled
glaucoma
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Previous eye surgery, Best corrected visual acuity <6/9, Chronic eye disease
(including glaucoma, Secondary glaucoma (eg uveitis, neovascular glaucoma, etc),
Advanced or fixation-threatening visual field changes, Ocular perfusion abnormalities
(e.g. previous retinal artery or vein occlusion; or abnormal vasculature including
those whose retinal circulation might be compromised by pressure on the eye).

Study design
Purpose of the study
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Capital Vision Research Trust
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Chronic glaucoma is one of the leading causes of blindness and visual loss in the developed
world. It is a condition where long term exposure to high eye pressures (intra-ocular
pressure) damages the nerve fibres in the eye. This damage can be seen by examiners as
changes in the optic nerve. The exact mechanism of how the high intra-ocular pressure causes
nerve damage is unknown. Both physiological and mechanical mechanisms are thought to play a
role. Previous authors have reported structural changes in the connective tissue of optic
nerves of eyes with glaucoma. Structural changes in the optic nerve head which affect the
mechanical compliance of the nerve may be significant in the cause of glaucomatous nerve
damage. This study aims to assess the compliance of the optic disc in subjects with and
without glaucoma. We would test compliance by imaging the optic discs of participants before
and during a brief (less than two minutes) increase in intra-ocular pressure. We would aim to
repeat the tests on the same subjects 3 years later to see how compliance changed. We would
also seek to correlate other important parameters such as corneal thickness and visual field
changes with our findings
Trial website
https://clinicaltrials.gov/ct2/show/NCT00328835
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony P Wells, FRANZCO
Address 0 0
CVRT, Wellington School Of Medicine - University of Otago
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00328835