Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-04 @ 3:25 PM
Study NCT ID:
NCT03293251
Status:
UNKNOWN
Last Update Posted:
2017-09-26
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-24', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-09-24', 'lastUpdatePostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rates', 'timeFrame': '5 year period', 'description': 'IOP less 21 mmHg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Outcomes of Trabeculectomy With MMC']}, 'descriptionModule': {'briefSummary': '1. determine whether cataract surgery has a major effect on outcomes of trabeculectomy with MMC or not.\n2. Success rates of trabeculectomy with MMC in Queen Elizabeth hospital.\n3. recurrence rate of uveitis after glaucoma surgery', 'detailedDescription': '1. determine different success rates of trabeculectomy with MMC undergone in QE hospital, UK.\n2. determine different complications and effect of cataract surgery on the outcome of glaucoma surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cohort of patient documented on the database system of Queen Elizabeth hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fesh trabeculectomy surgeries\n\nExclusion Criteria:\n\n* recurrent surgeries'}, 'identificationModule': {'nctId': 'NCT03293251', 'briefTitle': 'Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Trabeculectomy With MMC and I Stent in Uveitic Glaucoma and POAG : Outcomes and Prognostic Factors', 'orgStudyIdInfo': {'id': '1111'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'uveitic/ POAG', 'description': 'Outcomes, success rates, complications of trabeculectomy with MMC in Uveitic glaucoma', 'interventionNames': ['Procedure: Trabeculectomy with MMC']}, {'label': 'POAG', 'description': 'Outcomes, success rates, complications of trabeculectomy with MMC and I stent in this groups', 'interventionNames': ['Procedure: Trabeculectomy with MMC']}], 'interventions': [{'name': 'Trabeculectomy with MMC', 'type': 'PROCEDURE', 'otherNames': ['I-STENT'], 'description': 'glaucoma surgeries', 'armGroupLabels': ['POAG', 'uveitic/ POAG']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Egypt', 'state': 'Asyut Governorate', 'country': 'Egypt', 'facility': 'Maha Said'}], 'overallOfficials': [{'name': 'Dr Kamel Soliman, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Queen Elizabeth Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Maha omar mahmoud said', 'investigatorAffiliation': 'Assiut University'}}}}