The Influence of Vision on Balance, Gait and Falls

This study has been completed.
Sponsor:
Collaborator:
Helse Midt-Norge
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00218894
First received: September 20, 2005
Last updated: May 20, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Cataract
Procedure: Cataract surgery
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Cataract Surgery on Gait, Balance and Falls in Older Persons

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Falls [ Time Frame: over one year ] [ Designated as safety issue: No ]
  • Visual function [ Time Frame: pre surgery, 6-9 weeks and 1 year post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related Quality of Life [ Time Frame: pre surgery, 6-9 weeks and one year after surgery ] [ Designated as safety issue: No ]
  • Gait [ Time Frame: pre surgery, 6-9 weeks and one year after surgery ] [ Designated as safety issue: No ]
  • Fear of falling [ Time Frame: pre surgery, 6-9 weeks and one year after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: January 2004
Study Completion Date: December 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Cataract surgery
    surgery one one or two eyes by use of two different types of lenses and correcting for refraction
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

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218894

Locations
Norway
Section of Geriatric Medicine, St. Olavs University Hospital
Trondheim, Norway, N-7016
Sponsors and Collaborators
Norwegian University of Science and Technology
Helse Midt-Norge
Investigators
Principal Investigator: Olav Sletvold, Professor Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Olav Sletvold, Professor MD PhD, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00218894     History of Changes
Other Study ID Numbers: 196-03, Helse Midt-Norge
Study First Received: September 20, 2005
Last Updated: May 20, 2010
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Effect
Balance
Gait
Falls

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014