The Influence of Vision on Balance, Gait and Falls

This study is currently recruiting participants.

Verified by Norwegian University of Science and Technology, April 2008

First Received: September 20, 2005 Last Updated: April 18, 2008 History of Changes

Sponsors and Collaborators:	Norwegian University of Science and Technology Helse midt Norge
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00218894

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 I Phase II

MedlinePlus related topics: Cataract Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Cataract Surgery on Gait, Balance and Falls in Older Persons

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
Estimated Study Completion Date:	December 2010
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Contacts

Contact: Jorunn L Helbostad, PhD

+4773866872

jorunn.helbostad@medisin.ntnu.no

Locations

Norway
Section of Geriatric Medicine, St. Olavs University Hospital	Recruiting
Trondheim, Norway, N-7016
Contact: Jorunn L Helbostad, PhD +4773866872 jorunn.helbostad@medisin.ntnu.no
Sub-Investigator: Jorunn L Helbostad, PhD
Principal Investigator: Olav Sletvold, Professor
Sub-Investigator: Maria Ødegård, MSc

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:	Norwegian University of Science and Technology ( Olav Sletvold, Professor MD PhD )
Study ID Numbers:	196-03, Helse Midt-Norge
Study First Received:	September 20, 2005
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00218894 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

Effect
Balance
Gait
Falls

Study placed in the following topic categories:

Eye Diseases
Cataract
Lens Diseases

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on May 07, 2009