Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-26 @ 12:40 AM
Study NCT ID:
NCT04352660
Status:
COMPLETED
Last Update Posted:
2020-07-02
First Post:
2020-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Subconjunctival Versus Direct Mitomycin C in Trabeculectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}], 'ancestors': [{'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jiundo@ucsd.edu', 'phone': '8585346290', 'title': 'Dr. Jiun Do', 'organization': 'UCSD Shiley Eye Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Injection Group', 'description': 'MMC delivered by preoperative subconjunctival injection\n\nMitomycin-C injection: MMC delivered by preoperative subconjunctival injection', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 5, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sponge Group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges\n\nMitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 6, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypotony maculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Choroidal effusions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injection Group', 'description': 'MMC delivered by preoperative subconjunctival injection\n\nMitomycin-C injection: MMC delivered by preoperative subconjunctival injection'}, {'id': 'OG001', 'title': 'Sponge Group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges\n\nMitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges'}], 'classes': [{'categories': [{'title': 'Complete Success', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}, {'title': 'Qualified Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Failure', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Complete Failure', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Percentage of patients achieving at least a 30% mean intraocular pressure reductions from baseline and with an intraocular pressure \\<21 mm Hg. Subjects that met this criteria without the use of intraocular pressure lowering medications were classified as "Complete Success." Subjects that met this criteria but required the use of intraocular pressure lowering medications were classified as "Qualified Success." Subjects that failed to meet this criteria were classified as "Failure." Subjects that failed to meet this criteria and required additional glaucoma surgery were classified as "Complete Failure."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '14 subjects in the Injection group were lost to follow up at the 6 month postoperative visit. 10 subjects from the Sponge group were lost to follow up at the 6 month postoperative visit.'}, {'type': 'SECONDARY', 'title': 'Bleb Morphology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injection Group', 'description': 'MMC delivered by preoperative subconjunctival injection\n\nMitomycin-C injection: MMC delivered by preoperative subconjunctival injection'}, {'id': 'OG001', 'title': 'Sponge Group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges\n\nMitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges'}], 'classes': [{'title': 'Height', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '1.9'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '1.9'}]}]}, {'title': 'Extent', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '2.5'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '2.3'}]}]}, {'title': 'Vascularity', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '1.9'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '1.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Bleb morphology at 6 months was graded using Indiana Bleb Appearance Grading Scale. Bleb height was graded on a scale of 0 to 3 (0: flat bleb without visible elevation, 1: low bleb elevation, 2: moderate bleb elevation, 3: high bleb elevation). Bleb extent was graded on a scale of 0 to 3 (0: no visible bleb extent to less than 1 clock hour, 1: extent equal to or greater than 1 clock hour but less than 2 clock hours, 2: extent equal to or greater than 2 clock hours but less than 4 clock hours, 3: extent equal to or greater than 4 clock hours). Bleb vascularity was graded on a scale of 0 to 4 (0: avascular/white, 1: avascular/cystic, 2: mild vascularity, 3: moderate vascularity, 4: extensive vascularity). Scales are descriptive and do not necessarily represent better or worse outcomes.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'In the injection group, 14 subjects were lost to follow up and 17 subjects did not undergo bleb assessments at 6 months.In the sponge group, 10 subjects were lost to follow up and 20 subjects did not undergo bleb assessments at 6 months.'}, {'type': 'SECONDARY', 'title': 'Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injection Group', 'description': 'MMC delivered by preoperative subconjunctival injection\n\nMitomycin-C injection: MMC delivered by preoperative subconjunctival injection'}, {'id': 'OG001', 'title': 'Sponge Group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges\n\nMitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges'}], 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': '1', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '2', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '3', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of intraocular pressure lowering medications used by the patient at follow up visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'In the injection group, 14 subjects were lost to follow up and 1 subject did not have medications documented at 6 months. In the sponge group, 10 subjects were lost to follow up and 2 subjects did not have medications documented at 6 months.'}, {'type': 'SECONDARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injection Group', 'description': 'MMC delivered by preoperative subconjunctival injection\n\nMitomycin-C injection: MMC delivered by preoperative subconjunctival injection'}, {'id': 'OG001', 'title': 'Sponge Group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges\n\nMitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.22'}, {'value': '0.03', 'groupId': 'OG001', 'lowerLimit': '-0.09', 'upperLimit': '0.14'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Change in visual acuity from baseline', 'unitOfMeasure': 'logMAR', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'In the injection group, 14 subjects were lost to follow up at 6 months. In the sponge group, 10 subjects were lost to follow up at 6 months.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Surgical Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injection Group', 'description': 'MMC delivered by preoperative subconjunctival injection\n\nMitomycin-C injection: MMC delivered by preoperative subconjunctival injection'}, {'id': 'OG001', 'title': 'Sponge Group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges\n\nMitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges'}], 'classes': [{'title': 'Hypotony Maculopathy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Choroidal Effusions', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of eyes that experienced surgical complications following surgery', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Additional Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injection Group', 'description': 'MMC delivered by preoperative subconjunctival injection\n\nMitomycin-C injection: MMC delivered by preoperative subconjunctival injection'}, {'id': 'OG001', 'title': 'Sponge Group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges\n\nMitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges'}], 'classes': [{'title': 'Trab Revision', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'GDD', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Xen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Trabectome', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Any Surgery', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'CEIOL', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'YAG', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of eyes requiring additional surgery from each group', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Injection Group', 'description': 'MMC delivered by preoperative subconjunctival injection\n\nMitomycin-C injection: MMC delivered by preoperative subconjunctival injection'}, {'id': 'OG001', 'title': 'Sponge Group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges\n\nMitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges'}], 'classes': [{'title': '5FU Injection', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '4.0'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '4.3'}]}]}, {'title': 'Laser suture lysis', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '2.5'}, {'value': '1.6', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '2.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean number of postoperative interventions (needling, antifibrotic injections) performed in each group', 'unitOfMeasure': 'number of procedures', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Injection Group', 'description': 'MMC delivered by preoperative subconjunctival injection\n\nMitomycin-C injection: MMC delivered by preoperative subconjunctival injection'}, {'id': 'FG001', 'title': 'Sponge Group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges\n\nMitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Injection Group', 'description': 'MMC delivered by preoperative subconjunctival injection\n\nMitomycin-C injection: MMC delivered by preoperative subconjunctival injection'}, {'id': 'BG001', 'title': 'Sponge Group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges\n\nMitomycin-C sponge: MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.9', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '74.2', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '72.0', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'categories': [{'title': 'Primary open angle glaucoma', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Pseudoexfoliation glaucoma', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Pigmentary glaucoma', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Chronic angle closure glaucoma', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Visual Acuity', 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '0.34', 'groupId': 'BG000'}, {'value': '0.36', 'spread': '0.52', 'groupId': 'BG001'}, {'value': '0.335', 'spread': '0.44', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'logMAR', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Preoperative Visual Field Mean Deviation', 'classes': [{'categories': [{'measurements': [{'value': '-17.19', 'spread': '7.90', 'groupId': 'BG000'}, {'value': '-15.87', 'spread': '8.09', 'groupId': 'BG001'}, {'value': '-16.53', 'spread': '8.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Visual field mean deviation is measured in decibels (dB) and is the amount of visual field loss compared to age matched controls (people with no eye diseases or visual field loss). The brightness of flashes of light is measured in decibels and used to test the peripheral visual field. Subjects able to see dimmer lights than age matched controls will have positive values. Subjects who require brighter stimuli than age matched controls will have negative values.', 'unitOfMeasure': 'decibels', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Preoperative Pattern Standard Deviation', 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '8.9', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '9.15', 'spread': '3.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Visual field pattern standard deviation is measured in decibels (dB) and is the amount of irregular visual field loss compared to age matched controls (people with no eye diseases or visual field loss). The absolute values of the difference between visual field threshold value and the average visual field sensitivity are summed. Subjects with focal visual field defects will have a large pattern standard deviation. Subjects with normal or diffuse visual field defects will have a small pattern standard deviation.', 'unitOfMeasure': 'decibels', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Preoperative Intraocular Pressure', 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'spread': '7.2', 'groupId': 'BG000'}, {'value': '21.8', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '21.45', 'spread': '8.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Intraocular pressure is measured in millimeters of mercury . The intraocular pressure is measured in subjects using Goldmann applanation tonometry.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'IOP Goal', 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '12.7', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '12.2', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Medications', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '5', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-05', 'size': 271744, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-28T22:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-14', 'studyFirstSubmitDate': '2020-04-15', 'resultsFirstSubmitDate': '2020-05-28', 'studyFirstSubmitQcDate': '2020-04-15', 'lastUpdatePostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-14', 'studyFirstPostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds', 'timeFrame': '6 months', 'description': 'Percentage of patients achieving at least a 30% mean intraocular pressure reductions from baseline and with an intraocular pressure \\<21 mm Hg. Subjects that met this criteria without the use of intraocular pressure lowering medications were classified as "Complete Success." Subjects that met this criteria but required the use of intraocular pressure lowering medications were classified as "Qualified Success." Subjects that failed to meet this criteria were classified as "Failure." Subjects that failed to meet this criteria and required additional glaucoma surgery were classified as "Complete Failure."'}], 'secondaryOutcomes': [{'measure': 'Bleb Morphology', 'timeFrame': '6 months', 'description': 'Bleb morphology at 6 months was graded using Indiana Bleb Appearance Grading Scale. Bleb height was graded on a scale of 0 to 3 (0: flat bleb without visible elevation, 1: low bleb elevation, 2: moderate bleb elevation, 3: high bleb elevation). Bleb extent was graded on a scale of 0 to 3 (0: no visible bleb extent to less than 1 clock hour, 1: extent equal to or greater than 1 clock hour but less than 2 clock hours, 2: extent equal to or greater than 2 clock hours but less than 4 clock hours, 3: extent equal to or greater than 4 clock hours). Bleb vascularity was graded on a scale of 0 to 4 (0: avascular/white, 1: avascular/cystic, 2: mild vascularity, 3: moderate vascularity, 4: extensive vascularity). Scales are descriptive and do not necessarily represent better or worse outcomes.'}, {'measure': 'Medications', 'timeFrame': '6 months', 'description': 'Number of intraocular pressure lowering medications used by the patient at follow up visit.'}, {'measure': 'Visual Acuity', 'timeFrame': '6 months', 'description': 'Change in visual acuity from baseline'}, {'measure': 'Number of Participants With Surgical Complications', 'timeFrame': '6 months', 'description': 'Number of eyes that experienced surgical complications following surgery'}, {'measure': 'Number of Participants Requiring Additional Surgery', 'timeFrame': '6 months', 'description': 'Number of eyes requiring additional surgery from each group'}, {'measure': 'Postoperative Interventions', 'timeFrame': '6 months', 'description': 'Mean number of postoperative interventions (needling, antifibrotic injections) performed in each group'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trabeculectomy, mitomycin-C, glaucoma'], 'conditions': ['Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'Trabeculectomy is routinely used as a surgical treatment for open angle glaucoma. Success of trabeculectomy is greatly augmented by the use of antimetabolites to inhibit wound healing, specifically Mitomycin C (MMC). MMC can be applied to the eye at various sites, concentrations and times. This study aims to compare the two application routes that are commonly employed: subconjunctival pre-operative injection and intraoperative direct scleral application in terms of IOP lowering effect, bleb appearance and complications.', 'detailedDescription': 'Trabeculectomy is widely used as a surgical treatment of uncontrolled open glaucoma. Success of trabeculectomy at halting or slowing glaucoma progression primarily relies on the extent of conjunctival and sclera wound healing. The success rates of trabeculectomy increased dramatically with the introduction of anti-metabolites. For more than two decades mitomycin-c (MMC), a chemotherapeutic agent capable of decreasing fibroblast activity and modulating wound healing at the bleb, has been used with trabeculectomy. The complications of MMC are well known and several studies have described various methods of application based on exposure time, dose and surface area. Numerous retrospective and prospective studies have compared the efficacy of MMC applied beneath the conjunctival flap with soaked sponges versus intrascleral application. In 2008, Lee et al. first described an alternative route of application: subconjunctival injection of MMC directly into the intra-Tenon area. Seventy-six eyes with primary and secondary open angle glaucoma underwent trabeculectomy with this approach and were followed for one year post-operatively. Eighty-six percent of eyes achieved an IOP \\<21 mm Hg and 57% an IOP\\<14 mm Hg at one year without adjunctive drops. Transient complications included hyphema, bleb leak and choroidal detachment. The advantages of injected MMC are primarily in controlling the exact dosage and area of application and reduced surgical time. Lim et al. retrospectively reviewed the outcomes of trabeculectomy in 57 eyes using sponge application directly to the sclera versus intra-tenon injection. IOP was significantly lower in the injection group at 1 month, 1, 2, and 3 years. Trabeculectomy success (IOP\\<21mm Hg or IOP \\>20% below baseline without medications or additional surgery) was greater in the injection group at 3 years. The sponge group experienced more encapsulated blebs but complication rates were similar in both groups. To date, there have been no prospective studies comparing the IOP-lowering efficacy and safety of intra-tenon injection versus direct scleral application of MMC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medically uncontrolled glaucoma\n* healthy and freely mobile conjunctiva in superior bulbar region\n\nExclusion Criteria:\n\n* previous incisional glaucoma surgery\n* no light perception vision\n* pregnant or nursing women\n* iris neovascularization or proliferative retinopathy\n* iridocorneal endothelial syndrome\n* chronic or recurrent uveitis\n* steroid-induced glaucoma\n* pathologic myopia or refractive error less than -6.00 diopters\n* unwillingness or inability to give consent\n* inability to return for scheduled protocol visits'}, 'identificationModule': {'nctId': 'NCT04352660', 'briefTitle': 'Subconjunctival Versus Direct Mitomycin C in Trabeculectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Subconjunctival Versus Direct Scleral Application of Mitomycin-C in Trabeculectomy', 'orgStudyIdInfo': {'id': '151621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Injection group', 'description': 'MMC delivered by preoperative subconjunctival injection', 'interventionNames': ['Drug: Mitomycin-C injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sponge group', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges', 'interventionNames': ['Drug: Mitomycin-C sponge']}], 'interventions': [{'name': 'Mitomycin-C injection', 'type': 'DRUG', 'description': 'MMC delivered by preoperative subconjunctival injection', 'armGroupLabels': ['Injection group']}, {'name': 'Mitomycin-C sponge', 'type': 'DRUG', 'description': 'MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges', 'armGroupLabels': ['Sponge group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jiun L Do, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}, {'name': 'Robert N Weinreb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}, {'name': 'Benjamin Xu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jiun Do', 'investigatorAffiliation': 'University of California, San Diego'}}}}