Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Scientific title
Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.
Secondary ID [1] 0 0
350855
Universal Trial Number (UTN)
Trial acronym
VISIBLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - 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


BEHAVIORAL: Outdoor use of plain distance glasses with counselling
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Falls rates, Falls diaries
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Quality of life, SF-36
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Instrumental Activities of Daily Living, Adelaide Activities Profile
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Modified Falls Efficacy Scale
Timepoint [3] 0 0
12 months

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)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* nursing home residents

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
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
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
606
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Medical Research Institute - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
South Eastern Area Health Service
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Northern Sydney and Central Coast Area Health Service
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00350389
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.
Haran MJ, Cameron ID, Ivers RQ, Simpson JM, Lee BB, Tanzer M, Porwal M, Kwan MM, Severino C, Lord SR. Effect on falls of providing single lens distance vision glasses to multifocal glasses wearers: VISIBLE randomised controlled trial. BMJ. 2010 May 25;340:c2265. doi: 10.1136/bmj.c2265. Erratum In: BMJ. 2016 May 27;353:i3041. doi: 10.1136/bmj.i3041.
Haran MJ, Lord SR, Cameron ID, Ivers RQ, Simpson JM, Lee BB, Porwal M, Kwan MM, Severino C. Preventing falls in older multifocal glasses wearers by providing single-lens distance glasses: the protocol for the VISIBLE randomised controlled trial. BMC Geriatr. 2009 Mar 26;9:10. doi: 10.1186/1471-2318-9-10.
Public notes

Contacts
Principal investigator
Name 0 0
Stephen R Lord, PhD
Address 0 0
University of New South Wales
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/study/NCT00350389