Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-01 @ 5:01 PM
Study NCT ID:
NCT00477620
Status:
COMPLETED
Last Update Posted:
2009-02-23
First Post:
2007-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Myopia Acquisition and Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-19', 'studyFirstSubmitDate': '2007-05-23', 'studyFirstSubmitQcDate': '2007-05-23', 'lastUpdatePostDateStruct': {'date': '2009-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myopia', 'Prevention'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nTo determine whether the use of reading glasses blocks the near work mediated increased incidence of myopia in healthy school children.\n\nMethods:\n\nSMART enrolled 115 emmetropic children (ages 7-9 years). The children were recruited in the Principality of Liechtenstein. They were randomly assigned to either the control group (n=52) or to receive reading glasses with a lens power of +2.0 dioptres (n=63). The primary outcome measure was progression towards myopia as determined by autorefraction after cycloplegia. The secondary outcome measure was change in biometry measurements of corneal curvature, axial length, anterior chamber depth, crystalline lens thickness, and vitreous chamber depth using partial coherence interferometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emmetropia\n\nExclusion Criteria:\n\n* Ametropia'}, 'identificationModule': {'nctId': 'NCT00477620', 'acronym': 'SMART', 'briefTitle': 'Study of Myopia Acquisition and Prevention', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Study of Myopia Acquisition and Prevention in a Randomised Trial', 'orgStudyIdInfo': {'id': 'FR-2005-01-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Wearing of reading glasses during prolonged near work', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alexaner Reis, PD Dr. med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Augenwerk Liechtenstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Freiburg', 'class': 'OTHER'}}}}