Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 10:48 PM
Study NCT ID:
NCT00853905
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2009-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D015812', 'term': 'Glaucoma, Angle-Closure'}, {'id': 'D017889', 'term': 'Exfoliation Syndrome'}, {'id': 'D015355', 'term': 'Glaucoma, Neovascular'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014221', 'term': 'Triamcinolone'}, {'id': 'C072670', 'term': 'Hanks Balanced Salt Solution'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmolineaux@willseye.org', 'phone': '215-825-4713', 'title': 'Marlene Moster MD', 'organization': 'Wills Eye Hospital Glaucoma Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'surgery, day 1, 1 week, 1 month, 3 month, 6 month', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment 1(Triesence)', 'description': '0.2cc Triesence\n\nTriesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 8, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment 2 (Balanced Salt Solution BSS)', 'description': 'glaucoma surgery with balanced salt solution, the standard technique used.\n\nbalanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 10, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'IOP failure', 'notes': 'IOP failed to drop 20% or less than a 5mmhg drop from original IOP; eye drops added', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'choroidals drained; A/C reformed', 'notes': 'patient needed another glaucoma procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1(Triesence)', 'description': '0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.'}, {'id': 'OG001', 'title': 'Treatment 2 (Balanced Salt Solution BSS)', 'description': 'balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '19.05'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '15.0'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '14.5'}, {'value': '11.8', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '13.9'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000', 'lowerLimit': '13.0', 'upperLimit': '19.4'}, {'value': '14.4', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '16.8'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '18.4'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '15.1'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '17.8'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '11.5', 'upperLimit': '16.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day, 1week, 1 month, 3 month and 6 month post-op visits', 'description': 'Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was \\<21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.', 'unitOfMeasure': 'mm Hg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anterior Chamber Inflammation (Flare)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1(Triesence)', 'description': '0.2cc Triesence At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.'}, {'id': 'OG001', 'title': 'Treatment 2 (Balanced Salt Solution BSS)', 'description': 'balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.8'}, {'value': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '1.4'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.1'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.9'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '0.8'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '0.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month, 3 month and 6 month post-op visits', 'description': 'Inflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec).', 'unitOfMeasure': 'photon counts per millisecond (p/msec)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bleb Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Triesence (Treatment 1)', 'description': '0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.'}, {'id': 'OG001', 'title': 'Balanced Salt Solution (BSS Treatment 2)', 'description': 'balanced salt solution (BSS) At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.1'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '2.5'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.4', 'upperLimit': '2.1'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '2.3'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '2.6'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '2.3'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '2.4'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '2.2'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '2.3'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day, 1 week, 1 month, 3 month and 6 month post-op visits', 'description': 'A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Bleb assessment by IBAGS was not obtained at all visits. Overall, 20 of 37 (Triesence) and 20 of 40 (BSS) blebs were measured.'}, {'type': 'SECONDARY', 'title': 'Patient Comfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1(Triesence)', 'description': '0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.'}, {'id': 'OG001', 'title': 'Treatment 2 (Balanced Salt Solution BSS)', 'description': 'balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.6'}, {'value': '0.1', 'groupId': 'OG001', 'lowerLimit': '-0.1', 'upperLimit': '0.4'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.9'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.5'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.5'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.9'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.6'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.7'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '0.9'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day, 1 week, 1 month, 3 month and 6 month post-op visits', 'description': 'Questionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale.', 'unitOfMeasure': 'Patient comfort questionnaire score', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ocular Hypotensive Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1(Triesence)', 'description': '0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.'}, {'id': 'OG001', 'title': 'Treatment 2 (Balanced Salt Solution BSS)', 'description': 'balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.03', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.16'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.02', 'upperLimit': '0.2'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '0.26'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0.17'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.23'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.41'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000', 'lowerLimit': '0.11', 'upperLimit': '0.39'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.11', 'upperLimit': '0.41'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week, 1 month, 3 month, and or 6 month post-op visits', 'description': 'Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.', 'unitOfMeasure': 'eye drops', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment 1(Triesence)', 'description': '0.2cc Triesence\n\nAt end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.'}, {'id': 'FG001', 'title': 'Treatment 2 (Balanced Salt Solution BSS)', 'description': 'glaucoma surgery with balanced salt solution, the standard technique.\n\nAt end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'never had surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'February 2009 to July 2011 at the Wills Eye Hospital'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment 1(Triesence)', 'description': '0.2cc Triesence\n\nTriesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound'}, {'id': 'BG001', 'title': 'Treatment 2 (Balanced Salt Solution BSS)', 'description': 'glaucoma surgery with balanced salt solution, the standard technique used.\n\nbalanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '88'}, {'value': '69', 'groupId': 'BG001', 'lowerLimit': '42', 'upperLimit': '88'}, {'value': '68.5', 'groupId': 'BG002', 'lowerLimit': '42', 'upperLimit': '88'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Interocular Pressure (mmHg)', 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '40'}, {'value': '23.8', 'groupId': 'BG001', 'lowerLimit': '8.5', 'upperLimit': '56'}, {'value': '24.0', 'groupId': 'BG002', 'lowerLimit': '8.5', 'upperLimit': '56'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2009-02-27', 'resultsFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2009-02-27', 'lastUpdatePostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-02', 'studyFirstPostDateStruct': {'date': '2009-03-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP)', 'timeFrame': '1 day, 1week, 1 month, 3 month and 6 month post-op visits', 'description': 'Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was \\<21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.'}], 'secondaryOutcomes': [{'measure': 'Anterior Chamber Inflammation (Flare)', 'timeFrame': '1 month, 3 month and 6 month post-op visits', 'description': 'Inflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec).'}, {'measure': 'Bleb Appearance', 'timeFrame': '1 day, 1 week, 1 month, 3 month and 6 month post-op visits', 'description': 'A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery.'}, {'measure': 'Patient Comfort', 'timeFrame': '1 day, 1 week, 1 month, 3 month and 6 month post-op visits', 'description': 'Questionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale.'}, {'measure': 'Ocular Hypotensive Medications', 'timeFrame': '1 week, 1 month, 3 month, and or 6 month post-op visits', 'description': 'Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['open angle glaucoma (POAG)', 'angle closure glaucoma (PACG)', 'pigmentary glaucoma', 'pseudoexfoliation glaucoma', 'neovascular glaucoma', 'traumatic glaucoma'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '24794283', 'type': 'RESULT', 'citation': 'Koval MS, Moster MR, Freidl KB, Waisbourd M, Jain SG, Ichhpujani P, Myers JS, Pro MJ. Intracameral triamcinolone acetonide in glaucoma surgery: a prospective randomized controlled trial. Am J Ophthalmol. 2014 Aug;158(2):395-401.e2. doi: 10.1016/j.ajo.2014.04.027. Epub 2014 May 2.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.', 'detailedDescription': 'Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube)\n* primary open angle glaucoma\n* primary angle-closure glaucoma\n* pseudoexfoliation glaucoma\n* pigmentary glaucoma\n* traumatic glaucoma\n* neovascular glaucoma\n\nExclusion Criteria:\n\n* patients that are pregnant, nursing, or not using adequate contraception\n* any other eye surgery except cataract surgery\n* an infection, inflammation, or any abnormality preventing measurement of eye pressure\n* enrolled in another investigational study'}, 'identificationModule': {'nctId': 'NCT00853905', 'briefTitle': 'Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?', 'organization': {'class': 'OTHER', 'fullName': 'Wills Eye'}, 'officialTitle': 'The Effect of Intracameral Triesence (Triamcinolone Acetonide Injectable Suspension) on Ocular Inflammation After Trabeculectomy, Tube Shunt Implantation or Combined Trabeculectomy With Cataract Surgery', 'orgStudyIdInfo': {'id': '07-827'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment 1(Triesence)', 'description': 'glaucoma surgery with 0.2cc Triesence adjunct.', 'interventionNames': ['Drug: Triesence']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment 2 (balanced salt solution BSS)', 'description': 'glaucoma surgery with balanced salt solution, the standard technique.', 'interventionNames': ['Drug: balanced salt solution BSS']}], 'interventions': [{'name': 'Triesence', 'type': 'DRUG', 'otherNames': ['triamcinolone acetonide injectable'], 'description': 'At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.', 'armGroupLabels': ['Treatment 1(Triesence)']}, {'name': 'balanced salt solution BSS', 'type': 'DRUG', 'otherNames': ['balanced salt solution'], 'description': 'At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.', 'armGroupLabels': ['Treatment 2 (balanced salt solution BSS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Marlene R Moster, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wills Eye', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Surgeon Wills Eye Institute; Professor Jefferson Medical College', 'investigatorFullName': 'Marlene Moster, MD', 'investigatorAffiliation': 'Wills Eye'}}}}