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Completed

NCT Number: NCT00350389

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

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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Key information

Conditions

Falls

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Medical Research Institute

Sydney, New South Wales, 2031, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outdoor use of plain distance glasses with counselling

Behavioral

Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required

Primary outcomes

  1. Falls rates, Falls diaries

    Time frame: 12 months

Secondary outcomes

  1. Quality of life, SF-36

    Time frame: 12 months

  2. Instrumental Activities of Daily Living, Adelaide Activities Profile

    Time frame: 12 months

  3. Modified Falls Efficacy Scale

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Collaborators

  • Northern Sydney and Central Coast Area Health Service
  • South Eastern Area Health Service

Registry information

Official study title

Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.

Acronym: VISIBLE

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 10, 2006
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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