Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-30 @ 6:29 AM
Study NCT ID:
NCT01297803
Status:
UNKNOWN
Last Update Posted:
2011-02-17
First Post:
2011-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Method Antimetabolites Application on Corneal Function in Trabeculectomy Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-16', 'studyFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'corneal endothelial cell density', 'timeFrame': 'six month', 'description': 'specular microscopy'}, {'measure': 'corneal endothelial cell polymorphism', 'timeFrame': '6 months', 'description': 'specular microscopy'}, {'measure': 'corneal endothelial cell polymegathism', 'timeFrame': '6 months', 'description': 'specular microscopy'}], 'secondaryOutcomes': [{'measure': 'IOP (intra ocular pressure)', 'timeFrame': 'six months', 'description': 'applanation tonometry'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Glaucoma Patients Scheduled for Trabeculectomy']}, 'descriptionModule': {'briefSummary': 'Application of antimetabolite agents such as mitomycin\\_c has improved trabeculectomy results and better control of intraocular pressure complications such as corneal endothelial cell loss. However, Mitomycin\\_c can be applied remain a concern before or after sclera flap dissection. Mitomycin\\_c application after sclera flap dissection probably increases corneal endothelial cell loss. This study compares Mitomycin\\_c application two methods: before and after sclera flap dissection with regard to success rate and complication. patients on base of Mitomycin\\_c application time (1-2-3) minutes will be match randomise in to two groups( before and after sclera flap dissection) corneal. Endothelial cell density, polymorphism, polymegathism and intraocular pressure before and one month, three months, six months after surgery will measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age Range between 18 to 80 years old\n* Trabeculectomy to JOAC, POAG, CACG, PXF, pigment dispersion syndrome.\n\nExclusion Criteria:\n\n* Secondary glaucoma (active uveitis, NVG, specific syndromes such as axenfeld rieger, Iridocorneal Endothelial syndrome, aniridia, peters, etc).'}, 'identificationModule': {'nctId': 'NCT01297803', 'briefTitle': 'Comparison of Two Method Antimetabolites Application on Corneal Function in Trabeculectomy Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': 'Corneal Endothelial Cell Loss Following Trabeculectomy With mitomycin_c Application Before Versus After Sclera Flap Dissection', 'orgStudyIdInfo': {'id': '8772'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mitomycin_c application before sclera flap dissection', 'interventionNames': ['Drug: Mitomycin_c']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mitomycin_c application after sclera flapdissection', 'interventionNames': ['Drug: Mitomycin_c']}], 'interventions': [{'name': 'Mitomycin_c', 'type': 'DRUG', 'description': '0.02%.1,2,3,minutes match randomized in to two groups(before \\&after scleral flap dissection', 'armGroupLabels': ['Mitomycin_c application before sclera flap dissection']}, {'name': 'Mitomycin_c', 'type': 'DRUG', 'description': '0.02%.1,2,3,minutes match randomized in to two groups(before \\&after scleral flap dissection', 'armGroupLabels': ['Mitomycin_c application after sclera flapdissection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'shahin Yazdani', 'role': 'CONTACT', 'email': 'labbafi@hotmail.com', 'phone': '00982122585952'}, {'name': 'shahin yazdani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Labbafinejad medical center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Shahin Yazdani', 'oldOrganization': 'Ophthalmic Research center'}}}}