Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-26 @ 6:41 PM
Study NCT ID:
NCT00735657
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2008-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012164', 'term': 'Retinal Diseases'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009339', 'term': 'Needles'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-21', 'studyFirstSubmitDate': '2008-07-01', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of insulin needle.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Efficiency', 'Pars', 'Plana', 'Vitrectomy'], 'conditions': ['Retinal Disorders']}, 'descriptionModule': {'briefSummary': 'Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.', 'detailedDescription': 'The author wants to see the effect of short needle in patients undergoing retinal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing pars plana vitrectomy under local anesthesia\n\nExclusion Criteria:\n\n* Patients allergic to local anesthetic solutions\n* With local sepsis\n* Serious impairment of coagulation\n* Orbital abnormalities\n* Unable to cooperate in maintaining a relatively motionless supine position\n* Who refused the anesthetic technique'}, 'identificationModule': {'nctId': 'NCT00735657', 'briefTitle': 'Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle', 'organization': {'class': 'OTHER_GOV', 'fullName': 'King Khaled Eye Specialist Hospital'}, 'officialTitle': 'Anesthesia for PPV Using Insulin Needle', 'orgStudyIdInfo': {'id': 'Rp0822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Control', 'interventionNames': ['Device: needle', 'Procedure: Pars Plana Vitrectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Block with short needle', 'interventionNames': ['Device: needle', 'Procedure: Pars Plana Vitrectomy']}], 'interventions': [{'name': 'needle', 'type': 'DEVICE', 'otherNames': ['Peribulbar blockade with standard needle'], 'description': 'Peribulbar blockade with standard (25 mm) needle', 'armGroupLabels': ['Group 1']}, {'name': 'needle', 'type': 'DEVICE', 'otherNames': ['Peribulbar blockade with short needle'], 'description': 'Peribulbar blockade with short (12.5 mm) needle', 'armGroupLabels': ['Group 2']}, {'name': 'Pars Plana Vitrectomy', 'type': 'PROCEDURE', 'otherNames': ['Extraconal block'], 'description': 'Peribulbar block', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11462', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Khaled Eye Specialist hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Waleed Riad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KKESH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Khaled Eye Specialist Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}