Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-01-23 @ 7:30 PM
Study NCT ID:
NCT01667861
Status:
COMPLETED
Last Update Posted:
2015-05-25
First Post:
2012-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Factors for Glaucoma in Musicians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-22', 'studyFirstSubmitDate': '2012-08-10', 'studyFirstSubmitQcDate': '2012-08-16', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP levels, including IOP peaks occurring during or directly after playing, and prevalence of glaucomatous field loss in players of wind instruments.', 'timeFrame': 'One hour.'}, {'measure': 'IOP peaks and variations during continuous IOP monitoring', 'timeFrame': '24 hours', 'description': 'Several high-risk participants will be asked their permission to perform continuous IOP monitoring during 24 hours with a sensing contact lens.'}], 'secondaryOutcomes': [{'measure': 'Risk factors for glaucoma and the prevalence of visual problems and eye disease among (professional) musicians', 'timeFrame': '2 years', 'description': 'Participants of orchestras will be asked to fill in a questionnaire to collect demographic data together with data on musical history,ophthalmologic history and family history on glaucoma and ocular hypertension. From these participants, a selection will be invited for further screening.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Wind instruments'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the impact of playing wind instruments for the development of ocular hypertension and glaucoma, together with investigating the prevalence of visual problems and eye diseases in (professional) musicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '(Professional) musicians, who play in symphony or wind orchestras.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All full time or part time professional players of participating symphony or wind orchestras, including guest players.\n* Retired players, if possible.\n\nExclusion Criteria:\n\n* Difficulty in reading or speaking Dutch.'}, 'identificationModule': {'nctId': 'NCT01667861', 'briefTitle': 'Risk Factors for Glaucoma in Musicians', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Risk Factors for Glaucoma in Musicians', 'orgStudyIdInfo': {'id': 'NL25853.068.09/MEC09-2-112'}}, 'armsInterventionsModule': {'armGroups': [{'label': '(Wind) musicians', 'description': 'Members of (professional) orchestras, especially wind instrument players.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'University Eye Clinic, Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Henny JM Beckers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center, NL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henny Beckers', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stichting Glaucoomfonds', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, FEBophth', 'investigatorFullName': 'Henny Beckers', 'investigatorAffiliation': 'Maastricht University Medical Center'}}}}