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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00350389
Acronym
VISIBLE
Enrollment
606
Registered
2006-07-10
Start date
2005-06-30
Completion date
2008-12-31
Last updated
2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Falls

Keywords

Falls, Older persons

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.

Interventions

BEHAVIORALOutdoor use of plain distance glasses with counselling

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

Sponsors

South Eastern Area Health Service
CollaboratorOTHER
Northern Sydney and Central Coast Area Health Service
CollaboratorOTHER
The University of New South Wales
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Falls rates, Falls diaries12 months

Secondary

MeasureTime frame
Quality of life, SF-3612 months
Instrumental Activities of Daily Living, Adelaide Activities Profile12 months
Modified Falls Efficacy Scale12 months

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026