VISIBLE Study (Visual Intervention Strategy Incorporating Bifocal & Long-Distance Eyewear)

This study has been completed.
Sponsor:
Collaborators:
South Eastern Area Health Service
Northern Sydney and Central Coast Area Health Service
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00350389
First received: July 6, 2006
Last updated: February 13, 2009
Last verified: February 2009

July 6, 2006
February 13, 2009
June 2005
August 2008   (final data collection date for primary outcome measure)
Falls rates, Falls diaries [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Falls rates, Falls diaries
Complete list of historical versions of study NCT00350389 on ClinicalTrials.gov Archive Site
  • Quality of life, SF-36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Instrumental Activities of Daily Living, Adelaide Activities Profile [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Modified Falls Efficacy Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life, SF-36
  • Instrumental Activities of Daily Living, Adelaide Activities Index
Not Provided
Not Provided
 
VISIBLE Study (Visual Intervention Strategy Incorporating Bifocal & Long-Distance Eyewear)
Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.

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.

Background: Bi-, tri- and multi- focal ('multifocal') glasses have been associated with increased rates of falls in older people (Lord et al 2002).

Study Aim: 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.

Study Design: A randomised controlled assessor-blinded trial with two parallel groups in 580 participants. Study inclusion criteria are: 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+, and adequate visual contrast sensitivity (Melbourne Edge Test score of 16+dB). All participants will receive an optometry assessment and updated multifocal glasses (if required) at baseline. Intervention group subjects will receive a pair of plain distance glasses and counselling for their use in predominantly outdoor situations. Control group participants will use their multifocal glasses in their usual manner. Falls rates and compliance with the intervention will be recorded on monthly falls diaries returned by the participants.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Falls
Behavioral: Outdoor use of plain distance glasses with counselling
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
  • Experimental: 1
    Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
    Intervention: Behavioral: Outdoor use of plain distance glasses with counselling
  • No Intervention: 2
    Usual care, updated multifocal glasses if required
    Intervention: Behavioral: Outdoor use of plain distance glasses with counselling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
606
December 2008
August 2008   (final data collection date for primary outcome measure)

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)

Exclusion Criteria:

  • nursing home residents
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00350389
350855
Yes
Professor Stephen Lord, Prince of Wales Medical Research institute
The University of New South Wales
  • South Eastern Area Health Service
  • Northern Sydney and Central Coast Area Health Service
Principal Investigator: Stephen R Lord, PhD University of New South Wales
The University of New South Wales
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP