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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00218894
Other study ID # 196-03
Secondary ID Helse Midt-Norge
Status Completed
Phase N/A
First received September 20, 2005
Last updated January 16, 2017
Start date January 2004
Est. completion date December 2009

Study information

Verified date January 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date December 2009
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cataract surgery
surgery one one or two eyes by use of two different types of lenses and correcting for refraction

Locations

Country Name City State
Norway Section of Geriatric Medicine, St. Olavs University Hospital Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Helse Midt-Norge

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Falls over one year
Primary Visual function pre surgery, 6-9 weeks and 1 year post surgery
Secondary Health related Quality of Life pre surgery, 6-9 weeks and one year after surgery
Secondary Gait pre surgery, 6-9 weeks and one year after surgery
Secondary Fear of falling pre surgery, 6-9 weeks and one year after surgery
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