The Influence of Vision on Balance, Gait and Falls | NCT00218894

Studies
The Influence of Vision on Balance, Gait and Falls

NCT00218894

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Jan 18, 2017Estimated

Enrollment

148Actual

Phase

Not provided

Conditions

Cataract

Interventions

Cataract surgery

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Helse Midt-Norge

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Mar 2008Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 20, 2005

First Submission Date that Met QC Criteria

Sep 20, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2017

Last Update Posted Date

Jan 18, 2017Estimated

Name	Class
Helse Midt-Norge	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

148Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
post cataract surgery			Procedure: Cataract surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cataract surgery	Procedure	surgery one one or two eyes by use of two different types of lenses and correcting for refraction	post cataract surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Falls		over one year
Visual function		pre surgery, 6-9 weeks and 1 year post surgery

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olav Sletvold, Professor	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Section of Geriatric Medicine, St. Olavs University Hospital		Trondheim	Trondheim	N-7016	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23422945	Result	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.

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

ID	Term
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative