Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 5:59 PM
Study NCT ID:
NCT01023334
Status:
COMPLETED
Last Update Posted:
2010-08-02
First Post:
2009-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-30', 'studyFirstSubmitDate': '2009-12-01', 'studyFirstSubmitQcDate': '2009-12-01', 'lastUpdatePostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'observed levels of pain', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Topical analgesia', 'FlACC Pain Scale', 'intracameral lignocaine', 'Anesthetics', 'Physiological Effects of Drugs', 'Lidocaine'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intraocular lidocaine increases patient comfort during the different stages of MSICS while under topical anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both men and women\n* Cataract density grade III-V according to the Emery-Little system classification system\n* Patients need to do manual small incision cataract surgery\n\nExclusion Criteria:\n\n* Legal guardian(s) is/are not present for permission\n* Any patient with a known sensitivity or allergy to Lidocaine or the "Caine" family of medicines.\n* Patients with altered levels of pain perceptions'}, 'identificationModule': {'nctId': 'NCT01023334', 'briefTitle': 'Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia', 'orgStudyIdInfo': {'id': '10002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraocular lidocaine,topical anesthesia,MSICS', 'description': 'experimental group:manual small incision cataract surgery under topical anesthesia with intracameral lidocaine', 'interventionNames': ['Procedure: MSICS under topical anesthesia with intracameral lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'intracameral balanced salt solution,topical anesthesia,MSICS', 'description': 'control group:manual small incision cataract surgery under topical anesthesia with intracameral balanced salt solution.', 'interventionNames': ['Procedure: MSICS under topical anesthesia with intracameral balanced salt solution.']}], 'interventions': [{'name': 'MSICS under topical anesthesia with intracameral lidocaine', 'type': 'PROCEDURE', 'description': 'manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral lidocaine', 'armGroupLabels': ['Intraocular lidocaine,topical anesthesia,MSICS']}, {'name': 'MSICS under topical anesthesia with intracameral balanced salt solution.', 'type': 'PROCEDURE', 'description': 'manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral balanced salt solution.', 'armGroupLabels': ['intracameral balanced salt solution,topical anesthesia,MSICS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325027', 'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Eye Hospital, Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Wei Chen, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Hospital, Wenzhou Medical College, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Wei Chen', 'oldOrganization': 'Eye Hospital, Wenzhou Medical College'}}}}