Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-01-06 @ 7:09 AM
Study NCT ID:
NCT01019018
Status:
COMPLETED
Last Update Posted:
2021-10-21
First Post:
2009-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Subtenon's Block With Olive Tipped Cannula
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2009-11-17', 'studyFirstSubmitQcDate': '2009-11-24', 'lastUpdatePostDateStruct': {'date': '2021-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Akinesia score', 'timeFrame': '10 minutes after the block'}], 'secondaryOutcomes': [{'measure': 'Surgeon satisfactions score', 'timeFrame': 'At the end of the procedure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['subtenon block'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the efficacy of olive tip cannula to the standard Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient undergoing cataract extraction procedure under local anesthesia\n\nExclusion Criteria:\n\n* Patients allergic to local anesthetic solutions.\n* Presence local sepsis,\n* Previous retinal or strabismus surgery in the same eye.\n* Orbital abnormalities\n* Previous subtenon's block in the same quadrant."}, 'identificationModule': {'nctId': 'NCT01019018', 'briefTitle': "Efficacy of Subtenon's Block With Olive Tipped Cannula", 'organization': {'class': 'OTHER_GOV', 'fullName': 'King Khaled Eye Specialist Hospital'}, 'officialTitle': 'Efficacy of Subtenon Anesthesia With Olive Tipped Cannula: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RP 0928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stevens cannula', 'description': 'Subtenon with stevens cannula', 'interventionNames': ['Device: subtenon block']}, {'type': 'EXPERIMENTAL', 'label': 'Olive tip', 'description': 'Olive tip group', 'interventionNames': ['Device: subtenon block']}], 'interventions': [{'name': 'subtenon block', 'type': 'DEVICE', 'description': 'subtenon block with stevens cannula', 'armGroupLabels': ['Stevens cannula']}, {'name': 'subtenon block', 'type': 'DEVICE', 'description': 'subtenon block with Olive tip cannula cannula', 'armGroupLabels': ['Olive tip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11462', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'king Khaled Eye Specialist hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Khaled Eye Specialist Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}