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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Falls

Intervention / Treatment
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* Behavioral: Outdoor use of plain distance glasses with counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required | Behavioral: Outdoor use of plain distance glasses with counselling<br>* Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required<br>|
| No Intervention: 2<br>Usual care, updated multifocal glasses if required | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls rates, Falls diaries |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, SF-36 |  | 12 months | 
| Instrumental Activities of Daily Living, Adelaide Activities Profile |  | 12 months | 
| Modified Falls Efficacy Scale |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Falls, Older persons