Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000476831
Ethics application status
Approved
Date submitted
24/02/2012
Date registered
1/05/2012
Date last updated
1/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Magnetic resonance imaging of the vision centre of the brain in visually impaired versus normally sighted participants
Scientific title
3-Tesla MRI volumetric and diffusion tensor analyses of the primary visual cortex: A case-control study in visually impaired and normally sighted subjects
Secondary ID [1] 280027 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe visual impairment 285938 0
Condition category
Condition code
Eye 286128 286128 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Detailed anatomical mapping of the primary cortex using high resolution magnetic resonance imaging in patients with severe visual impairment compared with normally sighted volunteers. Consists of a single brain MRI of the occipital lobe of 60 minutes' duration.
Intervention code [1] 284347 0
Early detection / Screening
Intervention code [2] 284779 0
Other interventions
Comparator / control treatment
Active control: comparison with the primary visual cortex in participants with normal vision
Control group
Active

Outcomes
Primary outcome [1] 286605 0
Provision of a set of algorithmic criteria delineating primary visual cortex structural differences between subjects with visual impairment and those with normal vision.
Timepoint [1] 286605 0
On completion of the MRI scan
Secondary outcome [1] 296248 0
Nil
Timepoint [1] 296248 0
Nil

Eligibility
Key inclusion criteria
Cases: untreatable bilateral visual impairment due to retinitis pigmentosa, diabetic retinopathy, glaucoma or macular degeneration or with acquired retinal, optic nerve or ocular surface disease. Visual acuity of less than or equal to Snellen’s Test Type 6/60 for > 12 months. History of normal vision in adulthood.
Controls: visual acuity of greater than or equal to Snellen’s Test Type 6/12.
Intact visual cortex
Age greater than or equal to 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of traumatic occipital cortex injury
Cognitive or intellectual disability, or dementia
Pre-existing active psychiatric conditions including psychosis, bipolar disorder and schizophrenia
Claustrophobia

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Two groups, those severely visually impaired, and those will normal vision, receive the same intervention
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284787 0
Government body
Name [1] 284787 0
Australian Research Council
Country [1] 284787 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road,
Clayton, Victoria, 3800
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 283672 0
Hospital
Name [1] 283672 0
The Alfred
Address [1] 283672 0
Commercial Road,
Melbourne, Victoria, 3004
Country [1] 283672 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286778 0
The Alfred Human Research and Ethics Committee
Ethics committee address [1] 286778 0
Commercial Road,
Melbourne, Victoria, 3004
Ethics committee country [1] 286778 0
Australia
Date submitted for ethics approval [1] 286778 0
12/02/2011
Approval date [1] 286778 0
01/03/2011
Ethics approval number [1] 286778 0
44/11

Summary
Brief summary
We hypothesise that the structure of the primary visual cortex in severely visually impaired participants will differ from that in participants with normal vision. Our aim is to develop a method of identifying the primary visual cortex during exposure of the occipital lobe of the brain during neurosurgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33833 0
Address 33833 0
Country 33833 0
Phone 33833 0
Fax 33833 0
Email 33833 0
Contact person for public queries
Name 17080 0
Ms Helen Ackland
Address 17080 0
The Alfred Hospital,
Commercial Road,
Prahran, Victoria, 3004
Country 17080 0
Australia
Phone 17080 0
61 3 9076 2000
Fax 17080 0
Email 17080 0
[email protected]
Contact person for scientific queries
Name 8008 0
Ms Helen Ackland
Address 8008 0
The Alfred Hospital,
Commercial Road,
Prahran, Victoria, 3004
Country 8008 0
Australia
Phone 8008 0
61 3 9076 2000
Fax 8008 0
Email 8008 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.