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

Not Applicable

Completed

• Conditions: Falls
• Interventions: Behavioral: Outdoor use of plain distance glasses with counselling

• Registration Number: NCT00350389
• Lead Sponsor: The University of New South Wales

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.

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.

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2006-07-06
• Study First Submitted QC: 2006-07-06
• Study First Posted: 2006-07-10
• Primary Completion: 2008-08
• Study Completion: 2008-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 606

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Outdoor use of plain distance glasses with counselling	Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required

Primary Outcome Measures

Name	Time	Method
Falls rates, Falls diaries	12 months

Secondary Outcome Measures

Name	Time	Method
Modified Falls Efficacy Scale	12 months
Quality of life, SF-36	12 months
Instrumental Activities of Daily Living, Adelaide Activities Profile	12 months

Trial Locations

Locations (1)

Prince of Wales Medical Research Institute; 🇦🇺 Sydney, New South Wales, Australia