Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT00155402
Status:
WITHDRAWN
Last Update Posted:
2008-05-29
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Application of Fibrin Glue in Ocular Surface Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011625', 'term': 'Pterygium'}, {'id': 'D003320', 'term': 'Corneal Ulcer'}, {'id': 'D057112', 'term': 'Corneal Perforation'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D065306', 'term': 'Corneal Injuries'}, {'id': 'D005131', 'term': 'Eye Injuries'}, {'id': 'D005151', 'term': 'Facial Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}], 'ancestors': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'whyStopped': 'Short of supply of fibrin glue', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-03', 'completionDateStruct': {'date': '2008-03'}, 'lastUpdateSubmitDate': '2008-05-28', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2008-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cure of the diseases', 'timeFrame': '1week, 2 weeks, 3 weeks, 4 weeks'}], 'secondaryOutcomes': [{'measure': 'integrity of the ocular surface', 'timeFrame': '1week, 2 weeks, 3 weeks, 4 weeks'}, {'measure': 'visual acuity', 'timeFrame': '1week, 2 weeks, 3 weeks, 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fibrin glue', 'corneal perforation', 'pterygium', 'conjunctiva', 'corneal ulcer'], 'conditions': ['Pterygium', 'Corneal Ulcer']}, 'descriptionModule': {'briefSummary': "This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries, which includes pterygium surgery, corneal melting/perforation, Gunderson's flap, conjunctival laceration, and muscle/clinical/filtering surgery.", 'detailedDescription': 'This clinical trial tries to use tissue fibrin glues (Tisseel) to treat various ocular surface diseases or surgeries. The inclusion criteria are:\n\n1. ocular surface disease which may need amniotic membrane transplantation (corneal pro epithelization, pterygium surgery, etc)\n2. infectious or noninfectious corneal ulcer with perforation less than 3 mm\n3. conjunctival transplantation/suture\n4. corneal surgeries which can be treated by conventional suture technique or application with cyanoacrylic acid tissue glues.\n\nInformed consents will be obtained from the patients before applications. After surgeries, topical steroids and antibiotics will be used, and therapeutic contact lens will be used. The patients will be followed up for at least three months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ocular surface diseases, which are expected to be treated by tissue fibrin glues\n\nExclusion Criteria:\n\n* Pregnancy\n* Children younger than 3 years old'}, 'identificationModule': {'nctId': 'NCT00155402', 'briefTitle': 'The Application of Fibrin Glue in Ocular Surface Diseases', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Phase 1 Study of Applying Fibrin Glue in Patients With Corneal Ulcer or Patients Requiring Wound Closure by Suture', 'orgStudyIdInfo': {'id': '940208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Use of fibrin glue after corneal surgery or transplantation', 'interventionNames': ['Drug: tissue fibrin glue application (Tisseel)']}], 'interventions': [{'name': 'tissue fibrin glue application (Tisseel)', 'type': 'DRUG', 'description': 'Apply several droplets within several seconds to several minutes', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Dawan', 'country': 'Taiwan', 'facility': 'Wei-Li Chen', 'geoPoint': {'lat': 23.20917, 'lon': 120.18722}}], 'overallOfficials': [{'name': 'Fung-Rong Hu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wei-Li Chen/Assistant Professor', 'oldOrganization': 'National Taiwan University, Department of Ophthalmology'}}}}