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Sponsors and Collaborators: |
The University of New South Wales South Eastern Area Health Service Northern Sydney/Central Coast Area Health Service |
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Information provided by: | The University of New South Wales |
ClinicalTrials.gov Identifier: | NCT00350389 |
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.
Condition | Intervention |
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Falls |
Device: Outdoor use of plain distance glasses with counselling |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers. |
Estimated Enrollment: | 580 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | March 2008 |
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 criteriae 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.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephen R Lord, PhD | 612-9399-1000 ext 1081 | S.Lord@unsw.edu.au |
Contact: Mark J Haran, MMed | 612-9926-8705 ext 6611 | mharan@med.usyd.edu.au |
Australia, New South Wales | |
Prince of Wales Medical Research Institute | Recruiting |
Sydney, New South Wales, Australia, 2031 | |
Contact: Stephen R Lord, PhD 612-9399-1000 ext 1081 S.Lord@unsw.edu.au |
Principal Investigator: | Stephen R Lord, PhD | University of New South Wales |
Study ID Numbers: | 350855 |
Study First Received: | July 6, 2006 |
Last Updated: | July 6, 2006 |
ClinicalTrials.gov Identifier: | NCT00350389 |
Health Authority: | Australia: National Health and Medical Research Council |
Falls, Older persons |
Methamphetamine Amphetamine |