Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04398212
Status:
COMPLETED
Last Update Posted:
2020-08-10
First Post:
2020-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Computer Vision Syndrome Visual Sequelae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 733}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': '1 month', 'description': 'visual changes i.e. uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) using logMAR measurements following reduction of screen time'}, {'measure': 'near vision', 'timeFrame': '1 month', 'description': 'near vision changes following reduction of screen hours using card test, near visual acuity chart and near point test while the measurements will be diopters and lines of near chart'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Computer Vision Syndrome']}, 'descriptionModule': {'briefSummary': 'the university students will respond to CVS-F3 survey form and then they will be subjected to complete ophthalmic examination and investigations', 'detailedDescription': 'CVS-F3 is a survey form consisted of up to 30 questions regarding Computer Vision Syndrome (CVS) complains, thereafter a randomized sample of students will be subjected to complete ophthalmic examination including visual acuity and refractive measurements, intraocular pressure measurements, Slitlamp and fungus examinations, mfERG examinations. the sudents will be requested to decrease their screen time and the examinations will be repeated one month later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- University students\n\nExclusion Criteria:\n\n* Amblyopia\n* Anisometropia\n* strabismus\n* Previous eye surgery'}, 'identificationModule': {'nctId': 'NCT04398212', 'briefTitle': 'Computer Vision Syndrome Visual Sequelae', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Visual and Ocular Sequelae of Computer Vision Syndrome: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '5-10/4/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Non-complaining group', 'description': 'the students in this group are not complaining of CVS symptoms but will be examined to diagnose CVS or exclude it', 'interventionNames': ['Diagnostic Test: mfERG (multifocal-retinogram)']}, {'type': 'EXPERIMENTAL', 'label': 'Complaining group', 'description': 'the students in this group are complaining of CVS symptoms but will be examined to document their complains and correlate to clinical findings', 'interventionNames': ['Diagnostic Test: mfERG (multifocal-retinogram)']}], 'interventions': [{'name': 'mfERG (multifocal-retinogram)', 'type': 'DIAGNOSTIC_TEST', 'description': 'mfERG will be performed for the students to document the effect of CVS on retina', 'armGroupLabels': ['Complaining group', 'Non-complaining group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82425', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Mohammed Iqbal, MD. PhP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Ophthalmology', 'investigatorFullName': 'Prof. Mohammed Iqbal', 'investigatorAffiliation': 'Sohag University'}}}}