Clinical trial NCT00350389: VISIBLE Study (Visual Intervention Strategy Incorporating Bifocal & Long-distance Eyewear)
Official title: Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls
Keywords: Falls, Older persons
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: South Eastern Area Health Service
name: Northern Sydney and Central Coast Area Health Service
First posted: 2006-07-10
Enrollment: 606
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Falls rates, Falls diaries
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life, SF-36
timeFrame: 12 months
measure: Instrumental Activities of Daily Living, Adelaide Activities Profile
timeFrame: 12 months
measure: Modified Falls Efficacy Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Prince of Wales Medical Research Institute
state: New South Wales
Study officials:
affiliation: University of New South Wales
name: Stephen R Lord, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1046/j.1532-5415.2002.50502.x.
citation: Haran MJ, Cameron ID, Ivers RQ, Simpson JM, Lee BB, Tanzer M, Porwal M, Kwan MM, Severino C, Lord SR. Effect on falls of providing single lens distance vision glasses to multifocal glasses wearers: VISIBLE randomised controlled trial. BMJ. 2010 May 25;340:c2265. doi: 10.1136/bmj.c2265.
citation: Haran MJ, Lord SR, Cameron ID, Ivers RQ, Simpson JM, Lee BB, Porwal M, Kwan MM, Severino C. Preventing falls in older multifocal glasses wearers by providing single-lens distance glasses: the protocol for the VISIBLE randomised controlled trial. BMC Geriatr. 2009 Mar 26;9:10. doi: 10.1186/1471-2318-9-10.