Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-03-11 @ 7:00 AM
Study NCT ID:
NCT02805257
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ahmed Glaucoma Valve Surgery With Mitomycin-C
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': 'D015355', 'term': 'Glaucoma, Neovascular'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016685', 'term': 'Mitomycin'}, {'id': 'C072670', 'term': 'Hanks Balanced Salt Solution'}], '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': 'ying.han@ucsf.edu', 'phone': '415-476-3321', 'title': 'Ying Han, MD, PhD', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Over 1 Year', 'description': 'In our study protocol, we defined Serious Adverse Events as the following "A SAE is any adverse event that results in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, or a persistent or significant disability/incapacity."', 'eventGroups': [{'id': 'EG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 23, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 21, 'seriousNumAtRisk': 52, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Tube Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Choroidal Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suprachoroidal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyphema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vitreous hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shallow Anterior Chamber', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Corneal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol'}, {'id': 'OG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their one-year after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 1 mm Hg or less, the IOP for the study eye was the average of the 2 readings. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intraocular Pressure After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol'}, {'id': 'OG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '6.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their six-month after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Medications Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol'}, {'id': 'OG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Counted the number of glaucoma drops at six-month after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.', 'unitOfMeasure': 'glaucoma drops', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol'}, {'id': 'OG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS'}], 'classes': [{'categories': [{'measurements': [{'value': '12.81', 'spread': '6.98', 'groupId': 'OG000'}, {'value': '15.33', 'spread': '6.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the six-month after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to report visual acuity data at six months for one Mitomycin-C patient and six Balanced Salt Solution patients due to missing data entry.'}, {'type': 'SECONDARY', 'title': 'Number of Medications Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol'}, {'id': 'OG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Counted the number of glaucoma drops at one-year after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.', 'unitOfMeasure': 'glaucoma drops', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Intraoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol'}, {'id': 'OG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS'}], 'classes': [{'title': 'Hyphema', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Suprachoroidal Hemorrhage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day of Surgery', 'description': 'Intraoperative complications are characterized as problems that happened during surgery but which were not intended. All complications during surgery were listed and analyzed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol'}, {'id': 'OG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'spread': '7.33', 'groupId': 'OG000'}, {'value': '16', 'spread': '7.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the one-year after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to report visual acuity data at one year for three Mitomycin-C patients and eight Balanced Salt Solution patients due to missing data entry.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol'}, {'id': 'OG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS'}], 'classes': [{'title': 'Tube occlusion', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Choroidal effusion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Suprachoroidal hemorrhage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hyphema', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Vitreous hemorrhage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Shallow Anterior Chamber', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Corneal edema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Endophthalmitis, cystoid macular edema, hypotony maculopathy, tube-K touch, tube erosion, diplopia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Year', 'description': 'Postoperative complications are characterized as problems that happened after surgery but which were not intended. All complications up to the one-year after surgery visit observed were listed and analyzed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol'}, {'id': 'FG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.\n\nMitomycin-C: Intraoperative and postoperative injections of mitomycin-c/Mitosol'}, {'id': 'BG001', 'title': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.\n\nBalanced Salt Solution: Intraoperative and postoperative injections of BSS'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '13.4', 'groupId': 'BG000'}, {'value': '58.76', 'spread': '14.8', 'groupId': 'BG001'}, {'value': '55.6', 'spread': '14.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'Chinese', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Mexican', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-12-12', 'size': 445510, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-18T17:12', 'hasProtocol': True}, {'date': '2017-12-12', 'size': 226526, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-18T17:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'dispFirstSubmitDate': '2021-02-25', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-27', 'studyFirstSubmitDate': '2016-06-15', 'dispFirstSubmitQcDate': '2021-04-27', 'resultsFirstSubmitDate': '2022-03-28', 'studyFirstSubmitQcDate': '2016-06-16', 'dispFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-27', 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure After Surgery', 'timeFrame': '1 year', 'description': 'Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their one-year after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 1 mm Hg or less, the IOP for the study eye was the average of the 2 readings. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.'}], 'secondaryOutcomes': [{'measure': 'Intraocular Pressure After Surgery', 'timeFrame': '6 months', 'description': 'Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their six-month after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.'}, {'measure': 'Number of Medications Postoperatively', 'timeFrame': '6 months', 'description': 'Counted the number of glaucoma drops at six-month after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.'}, {'measure': 'Visual Acuity', 'timeFrame': '6 months', 'description': 'The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the six-month after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.'}, {'measure': 'Number of Medications Postoperatively', 'timeFrame': '1 year', 'description': 'Counted the number of glaucoma drops at one-year after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.'}, {'measure': 'Number of Participants With Intraoperative Complications', 'timeFrame': 'Day of Surgery', 'description': 'Intraoperative complications are characterized as problems that happened during surgery but which were not intended. All complications during surgery were listed and analyzed.'}, {'measure': 'Visual Acuity', 'timeFrame': '1 year', 'description': 'The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the one-year after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.'}, {'measure': 'Number of Participants With Postoperative Complications', 'timeFrame': '1 Year', 'description': 'Postoperative complications are characterized as problems that happened after surgery but which were not intended. All complications up to the one-year after surgery visit observed were listed and analyzed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma', 'Primary Open Angle Glaucoma', 'Secondary Glaucoma', 'Neovascular Glaucoma']}, 'descriptionModule': {'briefSummary': 'This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.', 'detailedDescription': 'Glaucoma is a leading cause irreversible blindness worldwide. Glaucoma valve surgeries such as Ahmed valve implantation, which are conventional surgeries performed to control intraocular pressure in eyes, are sometimes associated with complications due to fibrosis. Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) greater than or equal to 18 mm Hg.\n* Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure.\n* For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled.\n\nExclusion Criteria:\n\n* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.\n* Pregnant or nursing women.\n* Previous cyclodestruction or glaucoma drainage device (GDD) surgery.\n* Patients with nanophthalmos.\n* Patients with Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.\n* No light perception vision.\n* VA \\<20/200 in non-study eye.\n* Need for glaucoma surgery combined with other ocular procedures (i.e. cataract extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.\n* Previous scleral buckling procedure or silicone oil present.\n* Uveitic glaucoma.'}, 'identificationModule': {'nctId': 'NCT02805257', 'acronym': 'AMCT', 'briefTitle': 'Ahmed Glaucoma Valve Surgery With Mitomycin-C', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Ahmed Glaucoma Valve Surgery With Mitomycin-C', 'orgStudyIdInfo': {'id': 'IRB#16-18935'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mitomycin-C', 'description': '0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.', 'interventionNames': ['Drug: Mitomycin-C', 'Procedure: Ahmed Glaucoma Valve Implant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Balanced Salt Solution (BSS)', 'description': '0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.', 'interventionNames': ['Other: Balanced Salt Solution', 'Procedure: Ahmed Glaucoma Valve Implant']}], 'interventions': [{'name': 'Mitomycin-C', 'type': 'DRUG', 'otherNames': ['Mitosol'], 'description': 'Intraoperative and postoperative injections of mitomycin-c/Mitosol', 'armGroupLabels': ['Mitomycin-C']}, {'name': 'Balanced Salt Solution', 'type': 'OTHER', 'otherNames': ['BSS'], 'description': 'Intraoperative and postoperative injections of BSS', 'armGroupLabels': ['Balanced Salt Solution (BSS)']}, {'name': 'Ahmed Glaucoma Valve Implant', 'type': 'PROCEDURE', 'description': 'Implantation of Ahmed Valve in study eye', 'armGroupLabels': ['Balanced Salt Solution (BSS)', 'Mitomycin-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Raipur', 'state': 'Chhattisgarh', 'country': 'India', 'facility': 'Shri Ganesh Vinayak Eye Hospital', 'geoPoint': {'lat': 21.23333, 'lon': 81.63333}}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Asociación para Evitar la Ceguera en México (APEC)', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Ying Han, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No current plans to share IPD to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bascom Palmer Eye Institute', 'class': 'OTHER'}, {'name': 'University of North Carolina', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'University of Maryland', 'class': 'OTHER'}, {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, {'name': 'Hospital Central Militar', 'class': 'OTHER_GOV'}, {'name': 'Shri Ganesh Vinayak Eye Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}