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

This study has been completed.
Sponsor:
Collaborators:
South Eastern Area Health Service
Northern Sydney and Central Coast Area Health Service
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00350389
First received: July 6, 2006
Last updated: February 13, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention
Falls
 Behavioral: Outdoor use of plain distance glasses with counselling

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Falls rates, Falls diaries [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, SF-36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Instrumental Activities of Daily Living, Adelaide Activities Profile [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Modified Falls Efficacy Scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 606
Study Start Date: June 2005
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
 Behavioral: Outdoor use of plain distance glasses with counselling
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
No Intervention: 2
Usual care, updated multifocal glasses if required
 Behavioral: Outdoor use of plain distance glasses with counselling
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required

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.

  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

Locations
Australia, New South Wales
Prince of Wales Medical Research Institute
Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
The University of New South Wales
South Eastern Area Health Service
Northern Sydney and Central Coast Area Health Service
Investigators
Principal Investigator: Stephen R Lord, PhD University of New South Wales
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Stephen Lord, Prince of Wales Medical Research institute
ClinicalTrials.gov Identifier: NCT00350389     History of Changes
Other Study ID Numbers: 350855
Study First Received: July 6, 2006
Last Updated: February 13, 2009
Health Authority: Australia: National Health and Medical Research Council

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

Additional relevant MeSH terms:
Amphetamine
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
 Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013