Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
Please note the ANZCTR will be unattended on Monday the 7th of October for the Labour Day public holiday.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12605000144617
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
15/08/2005
Date last updated
15/08/2005
Type of registration
Retrospectively registered
Titles & IDs
Public title
Improving vision to prevent falls: a randomized trial
Query!
Scientific title
A randomized phase III trial to evaluate the effect of vision assessment and treatment among people aged 70 years and over to prevent falls
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Accidental falls
234
0
Query!
Condition category
Condition code
Injuries and Accidents
265
265
0
0
Query!
Other injuries and accidents
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Intervention group:
Vision and eye testing by an optometrist, with arrangement for any necessary treatments (including new glasses, cataract surgery, OT home modifications).
Query!
Intervention code [1]
150
0
Prevention
Query!
Comparator / control treatment
Control group: usual care
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
315
0
Falls during 12 months of follow-up.
Query!
Assessment method [1]
315
0
Query!
Timepoint [1]
315
0
Query!
Secondary outcome [1]
703
0
Vision-related quality of life.
Query!
Assessment method [1]
703
0
Query!
Timepoint [1]
703
0
Query!
Eligibility
Key inclusion criteria
Age 70 years or over, living in the community (not a hostel or nursing home), no cataract surgery in previous 3 months, no new glasses in previous 3 months.
Query!
Minimum age
70
Years
Query!
Query!
Maximum age
Not stated
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
No exclusion criteria
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed until after assignment ot study groups. Randomisation list held centrally by researcher with no contact with study subjects.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A published table of random numbers was used to generate the random allocation sequence. Randomisation was in blocks, stratified by falls history, sex and recruitment site.stratified by falls history, sex and recruitment site.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
The control receives usual care.
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
1/08/2002
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
800
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
322
0
Government body
Query!
Name [1]
322
0
National Health and Medical Research Council of Australia
Query!
Address [1]
322
0
Query!
Country [1]
322
0
Australia
Query!
Primary sponsor type
University
Query!
Name
University of Sydney
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
253
0
None
Query!
Name [1]
253
0
None
Query!
Address [1]
253
0
Query!
Country [1]
253
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
1233
0
University of Sydney
Query!
Ethics committee address [1]
1233
0
Query!
Ethics committee country [1]
1233
0
Australia
Query!
Date submitted for ethics approval [1]
1233
0
Query!
Approval date [1]
1233
0
Query!
Ethics approval number [1]
1233
0
Query!
Ethics committee name [2]
1234
0
Central Sydney Area Health Service-RPAH Zone
Query!
Ethics committee address [2]
1234
0
Query!
Ethics committee country [2]
1234
0
Australia
Query!
Date submitted for ethics approval [2]
1234
0
Query!
Approval date [2]
1234
0
Query!
Ethics approval number [2]
1234
0
Query!
Ethics committee name [3]
1235
0
Central Sydney Area Health Service-Concord Hospital Zone
Query!
Ethics committee address [3]
1235
0
Query!
Ethics committee country [3]
1235
0
Australia
Query!
Date submitted for ethics approval [3]
1235
0
Query!
Approval date [3]
1235
0
Query!
Ethics approval number [3]
1235
0
Query!
Summary
Brief summary
Poor vision is a risk factor for falls among older people but it is not known whether improving vision prevents falls. In this study, subjects in the intervention group have a comprehensive eye examination and receive appropriate treatment. It is hoped that this will result in fewer falls over the next 12 months than in an untreated control group.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
36270
0
Query!
Address
36270
0
Query!
Country
36270
0
Query!
Phone
36270
0
Query!
Fax
36270
0
Query!
Email
36270
0
Query!
Contact person for public queries
Name
9339
0
Robert G Cumming
Query!
Address
9339
0
Centre for Education and Research on Ageing
Concord Hospital
C25
Concord NSW 2139
Query!
Country
9339
0
Australia
Query!
Phone
9339
0
+61 2 97676818
Query!
Fax
9339
0
+61 2 97675419
Query!
Email
9339
0
bobc@health.usyd.edu.au
Query!
Contact person for scientific queries
Name
267
0
Robert G Cumming
Query!
Address
267
0
Centre for Education and Research on Ageing
Concord Hospital
C25
Concord NSW 2139
Query!
Country
267
0
Australia
Query!
Phone
267
0
+61 2 97676818
Query!
Fax
267
0
Query!
Email
267
0
bobc@health.usyd.edu.au
Query!
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF