NCT00218894

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

4.2 years

First QC Date

September 20, 2005

Last Update Submit

January 16, 2017

Conditions

Keywords

EffectBalanceGaitFalls

Outcome Measures

Primary Outcomes (2)

  • Falls

    over one year

  • Visual function

    pre surgery, 6-9 weeks and 1 year post surgery

Secondary Outcomes (3)

  • Health related Quality of Life

    pre surgery, 6-9 weeks and one year after surgery

  • Gait

    pre surgery, 6-9 weeks and one year after surgery

  • Fear of falling

    pre surgery, 6-9 weeks and one year after surgery

Study Arms (1)

post cataract surgery

Procedure: Cataract surgery

Interventions

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

post cataract surgery

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients (70 years and older) referred to cataract surgery in StOlavs Hospital, Trondheim Norway.

You may qualify if:

  • \>70 years of age
  • referred to cataract surgery on one or both eyes
  • able to walk unassisted at least 10 m

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Geriatric Medicine, St. Olavs University Hospital

Trondheim, Trondheim, N-7016, Norway

Location

Related 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.

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Olav Sletvold, Professor

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2005

First Posted

September 22, 2005

Study Start

January 1, 2004

Primary Completion

March 1, 2008

Study Completion

December 1, 2009

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations