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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/NCT00350389
Registration number
NCT00350389
Ethics application status
Date submitted
6/07/2006
Date registered
10/07/2006
Date last updated
3/06/2015
Titles & IDs
Public title
VISIBLE Study (Visual Intervention Strategy Incorporating Bifocal & Long-distance Eyewear)
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Scientific title
Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.
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Secondary ID [1]
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350855
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Universal Trial Number (UTN)
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Trial acronym
VISIBLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Falls
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Outdoor use of plain distance glasses with counselling
Experimental: 1 - Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
No Intervention: 2 - Usual care, updated multifocal glasses if required
Behaviour: Outdoor use of plain distance glasses with counselling
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Falls rates, Falls diaries
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Assessment method [1]
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Quality of life, SF-36
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Assessment method [1]
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Instrumental Activities of Daily Living, Adelaide Activities Profile
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Assessment method [2]
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Modified Falls Efficacy Scale
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Assessment method [3]
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Timepoint [3]
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12 months
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Eligibility
Key inclusion criteria
- outdoor use of multifocal glasses 3 or more times per week
- community-dwelling persons aged 65+ years with a recent fall OR persons aged 80+ years
regardless of falls history
- Folstein Mini Mental score of 24+
- adequate visual contrast sensitivity (Melbourne Edge Test score of 16+dB)
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- nursing home residents
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2008
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Sample size
Target
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Accrual to date
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Final
606
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Prince of Wales Medical Research Institute - Sydney
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Recruitment postcode(s) [1]
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2031 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of New South Wales
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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South Eastern Area Health Service
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Northern Sydney and Central Coast Area Health Service
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine whether the provision of supplementary plain
distance glasses for outdoor use to older users multifocal glasses will reduce falls rates
over a 12 month period.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00350389
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Trial related presentations / publications
Lord SR, Dayhew J, Howland A. Multifocal glasses impair edge-contrast sensitivity and depth perception and increase the risk of falls in older people. J Am Geriatr Soc. 2002 Nov;50(11):1760-6. doi: 10.1046/j.1532-5415.2002.50502.x.
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Public notes
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Contacts
Principal investigator
Name
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Stephen R Lord, PhD
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Address
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University of New South Wales
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00350389
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