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

Tracking Information

First Received Date ^ICMJE

July 6, 2006

Last Updated Date

February 13, 2009

Start Date ^ICMJE

June 2005

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Falls rates, Falls diaries

Change History

Complete list of historical versions of study NCT00350389 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Quality of life, SF-36
Instrumental Activities of Daily Living, Adelaide Activities Index

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Falls

Intervention ^ICMJE

Behavioral: Outdoor use of plain distance glasses with counselling

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

Study Arm (s)

Experimental: 1
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required

Intervention: Behavioral: Outdoor use of plain distance glasses with counselling
No Intervention: 2
Usual care, updated multifocal glasses if required

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

606

Completion Date

December 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00350389

Other Study ID Numbers ^ICMJE

350855

Has Data Monitoring Committee

Yes

Responsible Party

Professor Stephen Lord, Prince of Wales Medical Research institute

Study Sponsor ^ICMJE

The University of New South Wales

Collaborators ^ICMJE

South Eastern Area Health Service
Northern Sydney and Central Coast Area Health Service

Investigators ^ICMJE

Principal Investigator:

Stephen R Lord, PhD

University of New South Wales

Information Provided By

The University of New South Wales

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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