Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT00564356
Status:
UNKNOWN
Last Update Posted:
2009-07-21
First Post:
2007-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-19', 'studyFirstSubmitDate': '2007-11-26', 'studyFirstSubmitQcDate': '2007-11-26', 'lastUpdatePostDateStruct': {'date': '2009-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety and efficacy of cataract surgery with phacoemulsification under coumadin and antiaggregant treatment', 'timeFrame': '3.5 years'}], 'secondaryOutcomes': [{'measure': 'other complications', 'timeFrame': '3.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cataract, phacoemulsification, coumadin, antiaggregants'], 'conditions': ['Efficacy', 'Complications']}, 'referencesModule': {'references': [{'pmid': '17870045', 'type': 'RESULT', 'citation': 'Barequet IS, Sachs D, Priel A, Wasserzug Y, Martinowitz U, Moisseiev J, Salomon O. Phacoemulsification of cataract in patients receiving Coumadin therapy: ocular and hematologic risk assessment. Am J Ophthalmol. 2007 Nov;144(5):719-723. doi: 10.1016/j.ajo.2007.07.029. Epub 2007 Sep 17.'}]}, 'descriptionModule': {'briefSummary': 'To assess the risks of intra- and postoperative bleeding tendency associated with cataract surgery by phacoemulsification in patients on coumadin and antiaggregant treatments.\n\nDesign: Consecutive prospective study.', 'detailedDescription': 'To assess the risks of intra- and postoperative bleeding tendency associated with cataract surgery by phacoemulsification technique in patients on coumadin and antiaggregant treatment Design: Consecutive prospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who give informed consent to participate in the study\n\nExclusion Criteria:\n\n* single eye complicated cataract'}, 'identificationModule': {'nctId': 'NCT00564356', 'briefTitle': 'The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'The Safety of Cataract Removal by Phacoemulsification Surgery in Patients Under Anti-aggregant and Coumadin Treatment', 'orgStudyIdInfo': {'id': 'SHEBA-07-3017-OS-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'description': 'patients under coumadin and antiaggregants operated by phacoemulsification', 'interventionNames': ['Procedure: cataract surgery with phacoemulsification']}], 'interventions': [{'name': 'cataract surgery with phacoemulsification', 'type': 'PROCEDURE', 'description': 'removal of cataract with phacoemulsification technique', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Irina Barequet, md', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joseph Moisseiev, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Ophira Salomon, MD', 'role': 'CONTACT', 'email': 'ophiras@sheba.health.gov.il', 'phone': '972-3-5302104'}, {'name': 'Yael Wasserzug, MD', 'role': 'CONTACT', 'email': 'yawlwasserzug@gmail.com', 'phone': '972-3-5302874'}], 'overallOfficials': [{'name': 'Ophira Salomon', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Sheba Medical Center', 'oldOrganization': 'Sheba Medical Center'}}}}