Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-30 @ 11:36 AM
Study NCT ID:
NCT07034651
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2025-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electron Microscopic Examination of Iris Tissue in Buphthalmos
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D006871', 'term': 'Hydrophthalmos'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005124', 'term': 'Eye Abnormalities'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-14', 'studyFirstSubmitDate': '2025-06-14', 'studyFirstSubmitQcDate': '2025-06-14', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fibrovascular membrane over iris surface', 'timeFrame': '6 months', 'description': 'angle closure by a fibrovascular tissue proliferation over the trabecular meshwork in the anterior chamber angle'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iris tissue, buphthalmos'], 'conditions': ['Iris Diseases']}, 'descriptionModule': {'briefSummary': 'To revise the etiology of the primary congenital glaucoma in some infants.', 'detailedDescription': 'Combined trabeculotomy trabeculectomy with mitomycin C was done Electron microscopic examination of the peripheral iris tissue specimen was done in all cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infants under age of 2 years\n* 1ery glaucoma\n\nExclusion Criteria:\n\n* infants more than 2 years\n* 2ery glaucoma\n* previous glaucoma surgery'}, 'identificationModule': {'nctId': 'NCT07034651', 'briefTitle': 'Electron Microscopic Examination of Iris Tissue in Buphthalmos', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Electron Microscopic Examination of Iris Tissue in Buphthalmos', 'orgStudyIdInfo': {'id': '17200125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'isolated trabeculodysgensis', 'description': 'etiology of primary congenital glaucoma', 'interventionNames': ['Procedure: Combined trabeculotomy trabeculectomy with mitomycin C']}], 'interventions': [{'name': 'Combined trabeculotomy trabeculectomy with mitomycin C', 'type': 'PROCEDURE', 'description': 'Combined trabeculotomy trabeculectomy with mitomycin C with histopathological examination of the peripheral iris tissue specimen of all cases', 'armGroupLabels': ['isolated trabeculodysgensis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut univercity', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Hassan Lotfy Fahmy', 'investigatorAffiliation': 'Assiut University'}}}}