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VISIBLE Study (Visual Intervention Strategy Incorporating Bifocal & Long-Distance Eyewear)
This study is currently recruiting participants.
Verified by The University of New South Wales, June 2006
Sponsors and Collaborators: The University of New South Wales
South Eastern Area Health Service
Northern Sydney/Central Coast Area Health Service
Information provided by: The University of New South Wales
ClinicalTrials.gov Identifier: NCT00350389
  Purpose

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
Falls
Device: Outdoor use of plain distance glasses with counselling

MedlinePlus related topics: Eye Wear Methamphetamine
Drug Information available for: Amphetamine Methamphetamine
U.S. FDA Resources
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.

Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • Falls rates, Falls diaries

Secondary Outcome Measures:
  • Quality of life, SF-36
  • Instrumental Activities of Daily Living, Adelaide Activities Index

Estimated Enrollment: 580
Study Start Date: June 2005
Estimated Study Completion Date: March 2008
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 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350389

Contacts
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

Locations
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    
Sponsors and Collaborators
The University of New South Wales
South Eastern Area Health Service
Northern Sydney/Central Coast Area Health Service
Investigators
Principal Investigator: Stephen R Lord, PhD University of New South Wales
  More Information

Publications:
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

Keywords provided by The University of New South Wales:
Falls, Older persons

Study placed in the following topic categories:
Methamphetamine
Amphetamine

ClinicalTrials.gov processed this record on January 14, 2009