Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 5:58 PM
Study NCT ID:
NCT00218894
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2005-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Vision on Balance, Gait and Falls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-16', 'studyFirstSubmitDate': '2005-09-20', 'studyFirstSubmitQcDate': '2005-09-20', 'lastUpdatePostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Falls', 'timeFrame': 'over one year'}, {'measure': 'Visual function', 'timeFrame': 'pre surgery, 6-9 weeks and 1 year post surgery'}], 'secondaryOutcomes': [{'measure': 'Health related Quality of Life', 'timeFrame': 'pre surgery, 6-9 weeks and one year after surgery'}, {'measure': 'Gait', 'timeFrame': 'pre surgery, 6-9 weeks and one year after surgery'}, {'measure': 'Fear of falling', 'timeFrame': 'pre surgery, 6-9 weeks and one year after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Effect', 'Balance', 'Gait', 'Falls'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '23422945', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Elderly patients (70 years and older) referred to cataract surgery in StOlavs Hospital, Trondheim Norway.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>70 years of age\n* referred to cataract surgery on one or both eyes\n* able to walk unassisted at least 10 m\n\nExclusion Criteria:\n\n* terminal illness\n* have undergone orthopedic surgery in the lower limbs the last 12 months\n* Have had a stroke last 12 months\n* dementia (measured by MMSE \\<20'}, 'identificationModule': {'nctId': 'NCT00218894', 'briefTitle': 'The Influence of Vision on Balance, Gait and Falls', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The Effect of Cataract Surgery on Gait, Balance and Falls in Older Persons', 'orgStudyIdInfo': {'id': '196-03'}, 'secondaryIdInfos': [{'id': 'Helse Midt-Norge'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'post cataract surgery', 'interventionNames': ['Procedure: Cataract surgery']}], 'interventions': [{'name': 'Cataract surgery', 'type': 'PROCEDURE', 'description': 'surgery one one or two eyes by use of two different types of lenses and correcting for refraction', 'armGroupLabels': ['post cataract surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-7016', 'city': 'Trondheim', 'state': 'Trondheim', 'country': 'Norway', 'facility': 'Section of Geriatric Medicine, St. Olavs University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Olav Sletvold, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Midt-Norge', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}