Clinical Trials Directory

Trials / Completed

CompletedNCT00350389

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
606 (actual)
Sponsor
The University of New South Wales · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALOutdoor use of plain distance glasses with counsellingProvision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required

Timeline

Start date
2005-06-01
Primary completion
2008-08-01
Completion
2008-12-01
First posted
2006-07-10
Last updated
2015-06-03

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT00350389. Inclusion in this directory is not an endorsement.