Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT05151302
Status:
COMPLETED
Last Update Posted:
2025-05-01
First Post:
2021-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Italian Version of the Computer-Vision Symptom Scale Questionnaire: Translation, Validation and Reliability.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2021-11-11', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess reliability (Cronbach alpha) of the CVSS', 'timeFrame': 'one year', 'description': 'Cronbach alpha'}], 'secondaryOutcomes': [{'measure': 'To assess: -item internal consistency -equality of item-scale correlations -item discriminant validity -temporal stability -discriminating ability (between VDT and non-VDT workers) -external validity', 'timeFrame': 'one year', 'description': 'statistical examinations'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Video Display Terminal Workers', 'Computer Vision Syndrome']}, 'descriptionModule': {'briefSummary': "Video display terminal users frequently refer computer-related visual and ocular symptoms, that are the most frequently occurring health problems among such these subjects.\n\nThe Italian law has established an eye examination to assess ocular status (D.Lgs 81/08 ex law 626/96) in VDT workers: subjects are evaluated by clinical signs and symptoms. The availability of a validated questionnaire could be very useful to diagnose visual disturbances and to follow them during follow-up examinations in 2014, a Spanish group has developed and validated a questionnaire for the assessment of visual and ocular symptoms in VDT workers.\n\nAim of the present study is to make available to Italian health professionals a new instrument to assess asthenopic symptoms, taking into account the patient's perspective."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* VDT workers as defined by the Italian law (\\>20 hours a week on PC); in the control group patients no VDT workers.\n* VDT workers at the Foundation or VDT accessing to the general service of the Clinic for a routine visit (VDT group)\n* patients, not working at VDT, accessing to the "general service" of the eye clinic to perform a routine visit will be asked to participate the study (control group)\n* no ocular surgery in the preceding 6 months\n* written consent to participate to study procedures and personal data utilization in an encoded form\n\nExclusion Criteria:\n\n* ocular surgery in the preceding 6 months\n* patients unable to respond to questionnaire'}, 'identificationModule': {'nctId': 'NCT05151302', 'briefTitle': 'The Italian Version of the Computer-Vision Symptom Scale Questionnaire: Translation, Validation and Reliability.', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'The Italian Version of the Computer-Vision Symptom Scale Questionnaire: Translation, Validation and Reliability.', 'orgStudyIdInfo': {'id': 'CVSS17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'completion of the computer vision symptom scale questionnaire, italian version', 'description': 'video display terminal (VDT) workers completed the questionnaire', 'interventionNames': ['Diagnostic Test: computer vision symptom scale (CVSS) questionnaire']}], 'interventions': [{'name': 'computer vision symptom scale (CVSS) questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects working at VDT for \\>20 hours a week and accessing to the Eye Clinic in order to complete an ocular examination and subjects working at the Foundation accessing to the Eye Clinic in order to complete an ocular status evaluation according to Italian Law 81/08 will be asked to self-complete the questionnaire in presence of the attending junior ophthalmologists prior to the visit with the Ophthalmologist, to avoid interference with visit results (communication of bad/good news)', 'armGroupLabels': ['completion of the computer vision symptom scale questionnaire, italian version']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gemma Caterina M Rossi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'irccs policlinico san matteo foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gemma Caterina Maria Rossi', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}