- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218894
The Influence of Vision on Balance, Gait and Falls
January 16, 2017 updated by: Norwegian University of Science and Technology
The Effect of Cataract Surgery on Gait, Balance and Falls in Older Persons
Falls are the most serious and frequent home accident amongst elderly.
Most falls occur during walking.
Vision is reduced with ageing and visual impairments affect balance.
Uncorrected visual deficits and balance problems are reported to be risk factors for falls and fall related fractures.
The present project uses a longitudinal design and aims at assessing the impact of cataract surgery on balance and gait as risk factors for falls.
Study Overview
Detailed Description
A longitudinal design is used, where subjects referred to the Cataract Unit are tested 1-3 weeks in advance of the surgery, and 4-6 weeks and 12 months after the surgery.
Outcome measures are visual function, falls, balance and gait.
Secondary outcome is quality of life, fear of falling and daily life functioning
Study Type
Observational
Enrollment (Actual)
148
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Trondheim, Norway, N-7016
- Section of Geriatric Medicine, St. Olavs University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Elderly patients (70 years and older) referred to cataract surgery in StOlavs Hospital, Trondheim Norway.
Description
Inclusion Criteria:
- >70 years of age
- referred to cataract surgery on one or both eyes
- able to walk unassisted at least 10 m
Exclusion Criteria:
- terminal illness
- have undergone orthopedic surgery in the lower limbs the last 12 months
- Have had a stroke last 12 months
- dementia (measured by MMSE <20
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
post cataract surgery
|
surgery one one or two eyes by use of two different types of lenses and correcting for refraction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Falls
Time Frame: over one year
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over one year
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Visual function
Time Frame: pre surgery, 6-9 weeks and 1 year post surgery
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pre surgery, 6-9 weeks and 1 year post surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health related Quality of Life
Time Frame: pre surgery, 6-9 weeks and one year after surgery
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pre surgery, 6-9 weeks and one year after surgery
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Gait
Time Frame: pre surgery, 6-9 weeks and one year after surgery
|
pre surgery, 6-9 weeks and one year after surgery
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Fear of falling
Time Frame: pre surgery, 6-9 weeks and one year after surgery
|
pre surgery, 6-9 weeks and one year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Olav Sletvold, Professor, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 20, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
January 18, 2017
Last Update Submitted That Met QC Criteria
January 16, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 196-03
- Helse Midt-Norge
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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