Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT00949728
Status:
COMPLETED
Last Update Posted:
2009-07-30
First Post:
2009-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011625', 'term': 'Pterygium'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-29', 'studyFirstSubmitDate': '2009-07-17', 'studyFirstSubmitQcDate': '2009-07-29', 'lastUpdatePostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence of pterygium after its excision with the conjunctival autograft technique.', 'timeFrame': 'One, three and five months after surgery.'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications following the pterygium excision, such as partial graft detachment, dellen, granuloma or sutures failure.', 'timeFrame': 'One day, one week and one month after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pterygium', 'Autologous Transplantation', 'Conjunctiva', 'Fibrin Tissue Adhesive', 'Recurrence'], 'conditions': ['Pterygium', 'Primary']}, 'referencesModule': {'references': [{'pmid': '15205236', 'type': 'BACKGROUND', 'citation': 'Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4. doi: 10.1136/bjo.2003.032854.'}, {'pmid': '17514524', 'type': 'BACKGROUND', 'citation': 'Bahar I, Weinberger D, Gaton DD, Avisar R. Fibrin glue versus vicryl sutures for primary conjunctival closure in pterygium surgery: long-term results. Curr Eye Res. 2007 May;32(5):399-405. doi: 10.1080/02713680701294723.'}, {'pmid': '16331038', 'type': 'BACKGROUND', 'citation': 'Marticorena J, Rodriguez-Ares MT, Tourino R, Mera P, Valladares MJ, Martinez-de-la-Casa JM, Benitez-del-Castillo JM. Pterygium surgery: conjunctival autograft using a fibrin adhesive. Cornea. 2006 Jan;25(1):34-6. doi: 10.1097/01.ico.0000164780.25914.0a.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of primary pterygium\n* Symptomatic pterygium\n* Limbal invasion\n\nExclusion Criteria:\n\n* Secondary pterygium'}, 'identificationModule': {'nctId': 'NCT00949728', 'briefTitle': 'Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Olhos Sadalla Amin Ghanem'}, 'officialTitle': 'Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia', 'orgStudyIdInfo': {'id': 'cola106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fibrin glue', 'interventionNames': ['Procedure: Conjunctival autograft using fibrin glue']}], 'interventions': [{'name': 'Conjunctival autograft using fibrin glue', 'type': 'PROCEDURE', 'otherNames': ['Pterygium surgery using fibrin glue'], 'description': 'Conjunctival autograft using fibrin glue in pterygium surgery', 'armGroupLabels': ['Fibrin glue']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89201-010', 'city': 'Joinville', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Sadalla Amin Ghanem Eye Hospital', 'geoPoint': {'lat': -26.30444, 'lon': -48.84556}}], 'overallOfficials': [{'name': 'Renan F Oliveira', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ramon C Ghanem, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sadalla Amin Ghanem Eye Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Olhos Sadalla Amin Ghanem', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ramon Coral Ghanem', 'oldOrganization': 'Sadalla Amin Ghanem Eye Hospital'}}}}