Ignite Creation Date:
2025-12-25 @ 4:40 AM
Ignite Modification Date:
2026-04-14 @ 5:51 PM
Study NCT ID:
NCT01319318
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2011-03-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Vice President Medical Affairs,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pars Plana Vitrectomy', 'description': 'Pars plana vitrectomy performed in study eye on Day 0.', 'otherNumAtRisk': 25, 'otherNumAffected': 11, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Ocular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Vitreous Cell Count of 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pars Plana Vitrectomy', 'description': 'Pars plana vitrectomy performed in study eye on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 4', 'description': 'The study eye was dilated and the investigator used an instrument to count the number of visible cells in the vitreous, the jelly-like fluid that fills the back of the eye, using the following scale: 0 (no cells) best, +1 (1-10 cells), +2 (11-30 cells), +3 (31-50 cells) and +4 (\\>50 cells) worst.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population included all randomized participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pars Plana Vitrectomy', 'description': 'Pars plana vitrectomy performed in study eye on Day 0.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pars Plana Vitrectomy', 'description': 'Pars plana vitrectomy performed in study eye on Day 0.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.6', 'spread': '10.06', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-15', 'studyFirstSubmitDate': '2011-03-18', 'resultsFirstSubmitDate': '2013-04-15', 'studyFirstSubmitQcDate': '2011-03-18', 'lastUpdatePostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-15', 'studyFirstPostDateStruct': {'date': '2011-03-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Vitreous Cell Count of 0', 'timeFrame': 'Week 4', 'description': 'The study eye was dilated and the investigator used an instrument to count the number of visible cells in the vitreous, the jelly-like fluid that fills the back of the eye, using the following scale: 0 (no cells) best, +1 (1-10 cells), +2 (11-30 cells), +3 (31-50 cells) and +4 (\\>50 cells) worst.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vitrectomy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the degree of post-operative ocular inflammation in patients who are undergoing a pars plana vitrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who plan on undergoing a pars plana vitrectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Require pars plana vitrectomy in at least 1 eye\n* Best corrected visual acuity in the study eye between 20/400 and 20/40\n\nExclusion Criteria:\n\n* Use of any NSAIDs (topical or systemic) within 14 days\n* Use of topical or systemic steroids within 30 days\n* Active eye infection in either eye\n* Any eye surgery within 6 months\n* Prior pars plana vitrectomy, YAG capsulotomy or uveitis'}, 'identificationModule': {'nctId': 'NCT01319318', 'briefTitle': 'Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'GMA-OZU-10-017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pars Plana Vitrectomy', 'description': 'Pars plana vitrectomy performed in study eye on Day 0.', 'interventionNames': ['Procedure: Pars Plana Vitrectomy']}], 'interventions': [{'name': 'Pars Plana Vitrectomy', 'type': 'PROCEDURE', 'description': 'Pars plana vitrectomy performed in study eye on Day 0.', 'armGroupLabels': ['Pars Plana Vitrectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}