FallsVISIBLENCT00350389
VISIBLE Study (Visual Intervention Strategy Incorporating Bifocal & Long-distance Eyewear)
A study testing Outdoor use of plain distance glasses with counselling in people with Falls, run by The University of New South Wales at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls
- What is being tested?
- Outdoor use of plain distance glasses with counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2005to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- nursing home residents
Trial locations and contacts
1 site in 1 country.
Australia1 site
Prince of Wales Medical Research Institute
Sydney, New South Wales, 2031
About this study
Official title: Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.
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.
Read the 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.
- Conditions
- Falls
- Being tested
- Outdoor use of plain distance glasses with counselling
- Keywords
- Falls, Older persons
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor use of plain distance glasses with counsellingBehavioural
Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Provision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required Receives: Behavioral: Outdoor use of plain distance glasses with counselling |
| 2 | No intervention | Usual care, updated multifocal glasses if required |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls rates, Falls diaries
Measured: 12 months
Secondary outcomes (3)
Quality of life, SF-36
Measured: 12 months
Instrumental Activities of Daily Living, Adelaide Activities Profile
Measured: 12 months
Modified Falls Efficacy Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startJun 2005
- Primary completionAug 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- South Eastern Area Health Service, Northern Sydney and Central Coast Area Health Service
- Responsible party
- Principal investigator, Stephen Lord, The University of New South Wales
- Investigators
- Stephen R Lord, PhD, Principal investigator, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350389
- Sponsor's protocol ID
- 350855
- Acronym
- VISIBLE
- Status last verified
- Jun 2015
- First submitted
- 6 Jul 2006
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12410892Clemson L, Stark S, Pighills AC, Fairhall NJ, Lamb SE, Ali J, Sherrington C. Environmental interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2023 Mar 10;3(3):CD013258. doi: 10.1002/14651858.CD013258.pub2.
PubMed 36893804Haran 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.
PubMed 20501583Haran 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.
PubMed 19321012
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Falls Prevention Trial of Plain Distance Glasses in Elderly Multifocal Wearers.
- ClinicalTrials.gov ID
- NCT00350389
- Acronym / sponsor ID
- VISIBLE / 350855
- Conditions
- Falls
- Keywords
- Falls, Older persons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- South Eastern Area Health Service, Northern Sydney and Central Coast Area Health Service
- Study start
- Jun 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Outdoor use of plain distance glasses with counsellingProvision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required |
| 2 | No intervention | –Usual care, updated multifocal glasses if required |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (1 listed)
- nursing home residents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outdoor use of plain distance glasses with counsellingProvision of single lens glasses, glasses aids, counselling, updated multifocal glasses if required | Behavioural | 1 |
Primary outcome
Falls rates, Falls diaries
Time frame: 12 months
3 secondary outcomes
Quality of life, SF-36
Time frame: 12 months
Instrumental Activities of Daily Living, Adelaide Activities Profile
Time frame: 12 months
Modified Falls Efficacy Scale
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Background: PubMed 12410892Lord 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.
- Derived from this study: PubMed 36893804Clemson L, Stark S, Pighills AC, Fairhall NJ, Lamb SE, Ali J, Sherrington C. Environmental interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2023 Mar 10;3(3):CD013258. doi: 10.1002/14651858.CD013258.pub2.
- Derived from this study: PubMed 20501583Haran 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.
- Derived from this study: PubMed 19321012Haran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen R Lord, PhD principal investigator
University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor use of plain distance glasses with counselling in people with Falls, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Falls rates, Falls diaries (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00350389, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015; AzTrials last refreshed its copy on 31 Oct 2026.