Falls Clinical Trial
Official title:
Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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