Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT01070602
Status:
UNKNOWN
Last Update Posted:
2013-07-01
First Post:
2010-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-27', 'studyFirstSubmitDate': '2010-02-17', 'studyFirstSubmitQcDate': '2010-02-17', 'lastUpdatePostDateStruct': {'date': '2013-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of IFIS cases observed during operation.', 'timeFrame': 'during the operations'}], 'secondaryOutcomes': [{'measure': 'assessing the clinical grade of observed IFIS cases', 'timeFrame': 'during the operations'}]}, 'conditionsModule': {'keywords': ['IFIS'], 'conditions': ['Intraoperative Floppy Iris Syndrome']}, 'descriptionModule': {'briefSummary': 'Intraoperative Floppy Iris Syndrome (IFIS) may occur during cataract surgeries in patients treated with alpha 1 blockers. IFIS related to alpha 1 blocker Tamsulosin (used for prostate hypertrophy) was reported in 50-90% of patients. IFIS during surgery make the surgery more difficult and raise complication rate.\n\nUsing anterior corneal incisions was reported briefly in literature as a prophylactic means but was not studied prospectively. we believe (according to our clinical experience) that these anterior incisions do help to reduce the incidence and severity of IFIS signs and complications rate during surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. cataract candidates treated (in the present or in the past) with tamsulosin\n2. aged 55 or more\n3. candidates for topical anesthesia\n4. no allergy to anticholinergic or adrenergic drugs\n5. able to understand and sign an informed consent\n\nExclusion Criteria:\n\n1. history of uveitis\n2. iris neovascularization\n3. s/p iris surgery\n4. traumatic/uveitis induced cataract\n5. dialysis / abscence of zonules'}, 'identificationModule': {'nctId': 'NCT01070602', 'briefTitle': 'The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'orgStudyIdInfo': {'id': 'SRIFIS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anterior corneal incision', 'interventionNames': ['Procedure: anterior (more central) corneal paracentesis incision']}], 'interventions': [{'name': 'anterior (more central) corneal paracentesis incision', 'type': 'PROCEDURE', 'description': '3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.', 'armGroupLabels': ['anterior corneal incision']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Fani Segev, Md.', 'role': 'CONTACT', 'phone': '972-52-6995044'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}