Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-01-09 @ 6:29 AM
Study NCT ID:
NCT02124603
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2014-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Microbiological Evaluation of the Ocular Flora Before Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'santocono.m@alice.it', 'phone': '+393356070002', 'title': 'Dr.Marcello Santocono', 'organization': 'Casa di Cura Di Stefano'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Single Group', 'description': 'Patients to have to undergone cataract surgery', 'otherNumAtRisk': 120, 'otherNumAffected': 0, 'seriousNumAtRisk': 120, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Positive Culture in Subjects Scheduled for Cataract Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Group', 'description': 'Patients undergone cataract surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At least 14 days before surgery', 'description': 'Number of participants with positive culture at the screening visit', 'unitOfMeasure': 'subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with positive culture'}, {'type': 'SECONDARY', 'title': 'Antibiotic Susceptibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}, {'units': 'strains', 'counts': [{'value': '131', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Group', 'description': 'patients undergone cataract surgery'}], 'classes': [{'title': 'netilmicin', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}, {'title': 'moxifloxacin', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}]}]}, {'title': 'chloramphenicol', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'levofloxacin', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'tobramycin', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'ofloxacin', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'azythromycin', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At least 14 days before surgery', 'description': 'Isolated bacteria were tested for their in vitro susceptibility to commercially available ophthalmic antibiotics by the disk diffusion test and categorized as susceptible, intermediate or resistant.', 'unitOfMeasure': 'percentage of susceptible isolates', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'strains', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Percentage of isolates susceptibility to antibiotics'}, {'type': 'SECONDARY', 'title': 'Eradication Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Single Group', 'description': 'Patients undergone cataract surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of surgery', 'description': 'Number of participants having positive culture at the screening visit with bacterial eradication before surgery', 'unitOfMeasure': 'partecipants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with positive culture at the screening visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single Group', 'description': 'Patients undergone cataract surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Single Group', 'description': 'Consecutive patients scheduled for cataract surgery'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.3', 'spread': '8.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Conjunctival and palpebral swab of the eye undergoing surgery'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-15', 'studyFirstSubmitDate': '2014-04-23', 'resultsFirstSubmitDate': '2015-07-20', 'studyFirstSubmitQcDate': '2014-04-25', 'lastUpdatePostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-27', 'studyFirstPostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Culture in Subjects Scheduled for Cataract Surgery', 'timeFrame': 'At least 14 days before surgery', 'description': 'Number of participants with positive culture at the screening visit'}], 'secondaryOutcomes': [{'measure': 'Antibiotic Susceptibility', 'timeFrame': 'At least 14 days before surgery', 'description': 'Isolated bacteria were tested for their in vitro susceptibility to commercially available ophthalmic antibiotics by the disk diffusion test and categorized as susceptible, intermediate or resistant.'}, {'measure': 'Eradication Rate', 'timeFrame': 'Day of surgery', 'description': 'Number of participants having positive culture at the screening visit with bacterial eradication before surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cataract', 'prophylaxis', 'susceptibility'], 'conditions': ['Disorders of the Eye Following Cataract Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to elucidate the spectrum of ocular flora and their antimicrobial susceptibility profiles in patients undergoing routine cataract surgery.', 'detailedDescription': 'A conjunctival and palpebral swab will executed at least 14 days before routine cataract surgery. Isolates will be identified using standard microbiological protocols. In vitro susceptibility will be determined using a breakpoint minimal inhibitory concentrations. In case of positivity, the swab will be repeated the day of surgery. Topical antibiotic may be used in case of positivity at the discretion of the surgeon. Descriptive statistics will be calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing routine cataract surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for cataract surgery\n* Age \\> 18 years\n* Any gender and race\n* Willing to sign informed consent\n\nExclusion Criteria:\n\n* Any antibiotics within 3 months\n* Any ocular infection within 3 months'}, 'identificationModule': {'nctId': 'NCT02124603', 'briefTitle': 'Microbiological Evaluation of the Ocular Flora Before Cataract Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'SIFI SpA'}, 'officialTitle': 'Evaluation of Ocular Flora in Patients Undergoing Cataract Surgery. An Observational Study', 'orgStudyIdInfo': {'id': '041SI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single group', 'description': 'Patients undergone cataract surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95100', 'city': 'Catania', 'state': 'Catania', 'country': 'Italy', 'facility': 'Casa di Cura Di Stefano', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}], 'overallOfficials': [{'name': 'Marcello Santocono, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Casa Di Cura Di Stefano Catania (Italy)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SIFI SpA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}