Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-04 @ 3:22 AM
Study NCT ID:
NCT04617158
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2020-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Adjustable Sutures Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2020-10-30', 'studyFirstSubmitQcDate': '2020-11-04', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alignment of the strabismus', 'timeFrame': '3 months', 'description': 'Percentage of patients with successful postoperative alignment using prism cover test for measurement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Strabismus, Comitant']}, 'descriptionModule': {'briefSummary': 'Adjustable suture surgery will be done in patients with horizontal strabismus comparing the time of adjustment', 'detailedDescription': 'Forty patients will be equally divided into two groups and time of adjustment of the suture will be compared as regards efficacy and pain tolerance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* More than 16 years old patients Comitant esodeviation and exodeviation 15-45 prism diopters Cooperative patients\n\nExclusion Criteria:\n\n* Patients with previous strabismus surgery Patients with oblique deviations'}, 'identificationModule': {'nctId': 'NCT04617158', 'briefTitle': 'Comparing Adjustable Sutures Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Comparison Between Immediate Versus Late Postoperative Adjustable Eye Muscle Surgery', 'orgStudyIdInfo': {'id': 'Minia University 2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early adjustable suture surgery', 'description': 'Suture adjustment after 2 hours of surgery', 'interventionNames': ['Procedure: Adjustable strabismus surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late adjustable suture surgery', 'description': 'Suture adjustment after 24 hours of surgery', 'interventionNames': ['Procedure: Adjustable strabismus surgery']}], 'interventions': [{'name': 'Adjustable strabismus surgery', 'type': 'PROCEDURE', 'description': 'Adjustable surgery will be done using sliding nose technique using fornix approach', 'armGroupLabels': ['Early adjustable suture surgery', 'Late adjustable suture surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Faculty of Medicine- Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Sahar TA Abdelaziz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Minia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sahar T A Abdelaziz', 'investigatorAffiliation': 'Minia University'}}}}