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

The University of New South Wales

Status: Completed

Conditions: Falls

Treatments: Behavioral: Outdoor use of plain distance glasses with counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT00350389

350855

Details and patient eligibility

About

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.

Full 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.

Enrollment: 606 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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606 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Behavioral: Outdoor use of plain distance glasses with counselling

2

No Intervention group

Description:

Usual care, updated multifocal glasses if required