CataractNCT00218894
The Influence of Vision on Balance, Gait and Falls
An observational study of Cataract, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 148 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2004to Dec 2009
- Phase
- Observational
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients (70 years and older) referred to cataract surgery in StOlavs Hospital, Trondheim Norway.
Who may be able to join
- >70 years of age
- referred to cataract surgery on one or both eyes
- able to walk unassisted at least 10 m
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Section of Geriatric Medicine, St. Olavs University Hospital
Trondheim, Trondheim, N-7016
About this study
Official title: 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.
Read the 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
- Conditions
- Cataract
- Being tested
- Cataract surgery
- Keywords
- Effect, Balance, Gait, Falls
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cataract surgeryProcedure or surgery
surgery one one or two eyes by use of two different types of lenses and correcting for refraction
| Study group | Role | What they receive |
|---|---|---|
| post cataract surgery | Not described Receives: Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls
Measured: over one year
Visual function
Measured: pre surgery, 6-9 weeks and 1 year post surgery
Secondary outcomes (3)
Health related Quality of Life
Measured: pre surgery, 6-9 weeks and one year after surgery
Gait
Measured: pre surgery, 6-9 weeks and one year after surgery
Fear of falling
Measured: pre surgery, 6-9 weeks and one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionMar 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Midt-Norge
- Responsible party
- Sponsor
- Investigators
- Olav Sletvold, Professor, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218894
- Sponsor's protocol ID
- 196-03
- Other IDs
- Helse Midt-Norge
- Status last verified
- Jan 2017
- First submitted
- 20 Sep 2005
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Helbostad JL, Oedegaard M, Lamb SE, Delbaere K, Lord SR, Sletvold O. Change in vision, visual disability, and health after cataract surgery. Optom Vis Sci. 2013 Apr;90(4):392-9. doi: 10.1097/OPX.0b013e3182843f16.
PubMed 23422945
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cataract Surgery on Gait, Balance and Falls in Older Persons
- ClinicalTrials.gov ID
- NCT00218894
- Acronym / sponsor ID
- 196-03
- Conditions
- Cataract
- Keywords
- Effect, Balance, Gait, Falls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Midt-Norge
- Study start
- Jan 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Sep 2005 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| post cataract surgery | – | Procedure: Cataract surgery |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients (70 years and older) referred to cataract surgery in StOlavs Hospital, Trondheim Norway.
Key inclusion criteria (3 listed)
- >70 years of age
- referred to cataract surgery on one or both eyes
- able to walk unassisted at least 10 m
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Cataract surgerysurgery one one or two eyes by use of two different types of lenses and correcting for refraction | Procedure or surgery | post cataract surgery |
Primary outcome
Falls
Time frame: over one year
Visual function
Time frame: pre surgery, 6-9 weeks and 1 year post surgery
3 secondary outcomes
Health related Quality of Life
Time frame: pre surgery, 6-9 weeks and one year after surgery
Gait
Time frame: pre surgery, 6-9 weeks and one year after surgery
Fear of falling
Time frame: pre surgery, 6-9 weeks and one year after surgery
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 18 Jan 2017.
- Results publication: PubMed 23422945Helbostad JL, Oedegaard M, Lamb SE, Delbaere K, Lord SR, Sletvold O. Change in vision, visual disability, and health after cataract surgery. Optom Vis Sci. 2013 Apr;90(4):392-9. doi: 10.1097/OPX.0b013e3182843f16.
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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.
Olav Sletvold, Professor principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 inclusion and 4 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 18 Jan 2017. 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 Norway. 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 (time frame: over one year). The study lists 2 primary outcomes in all. 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 NCT00218894, which also lists 1 linked publication.
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 18 Jan 2017.