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

Falls Clinical Trial

— VISIBLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350389
• Other study ID #: 350855
• Status: Completed
• Phase: N/A
• First received: July 6, 2006
• Last updated: June 1, 2015
• Start date: June 2005
• Est. completion date: December 2008

Study information

• Verified date: June 2015
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Falls

Intervention

Behavioral:
• Outdoor use of plain distance glasses with counselling
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required

Locations

Country	Name	City	State
Australia	Prince of Wales Medical Research Institute	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
The University of New South Wales	Northern Sydney and Central Coast Area Health Service, South Eastern Area Health Service

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Lord SR, Dayhew J, Howland A. Multifocal glasses impair edge-contrast sensitivity and depth perception and increase the risk of falls in older people. J Am Geriatr Soc. 2002 Nov;50(11):1760-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls rates, Falls diaries		12 months	No
Secondary	Quality of life, SF-36		12 months	No
Secondary	Instrumental Activities of Daily Living, Adelaide Activities Profile		12 months	No
Secondary	Modified Falls Efficacy Scale		12 months	No