Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-05 @ 12:49 AM
Study NCT ID:
NCT04468633
Status:
COMPLETED
Last Update Posted:
2024-09-05
First Post:
2020-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Baerveldt Versus ClearPath Comparison Study
Sponsor:
Organization:
Raw JSON
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'title': 'Ahmed ClearPath 350 Implant', 'description': 'Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 8, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Surgical failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 8}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Myocardial infarction (heart attack)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baerveldt 350 Implant', 'description': 'Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.'}, {'id': 'OG001', 'title': 'Ahmed ClearPath 350 Implant', 'description': 'Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.7', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '22.4', 'spread': '6.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.9', 'spread': '12.1', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '9.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.1', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.687', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Baseline', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.384', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Day 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.597', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.860', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 4', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Week 6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Month 3', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.172', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Month 6', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Year 1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Participants with data collected at each timepoint.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced a Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baerveldt 350 Implant', 'description': 'Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.'}, {'id': 'OG001', 'title': 'Ahmed ClearPath 350 Implant', 'description': 'Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Year 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Corrected Visual Acuity (BCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baerveldt 350 Implant', 'description': 'Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.'}, {'id': 'OG001', 'title': 'Ahmed ClearPath 350 Implant', 'description': 'Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '0.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.84', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.46', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}, {'units': 'eyes', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes', 'populationDescription': 'Participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baerveldt 350 Implant', 'description': 'Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.'}, {'id': 'OG001', 'title': 'Ahmed ClearPath 350 Implant', 'description': 'Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1', 'unitOfMeasure': 'medications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at each timepoint.'}, {'type': 'SECONDARY', 'title': 'Change in Humphrey Visual Field (HVF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baerveldt 350 Implant', 'description': 'Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.'}, {'id': 'OG001', 'title': 'Ahmed ClearPath 350 Implant', 'description': 'Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.81', 'spread': '9.58', 'groupId': 'OG000'}, {'value': '4.72', 'spread': '13.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.759', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Year 1', 'description': 'The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive value indicates an increase in visual field while a negative value indicates a decrease.', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at both timepoints.'}, {'type': 'SECONDARY', 'title': 'Change in Thickness of the Cornea as Measured by Pachymetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baerveldt 350 Implant', 'description': 'Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.'}, {'id': 'OG001', 'title': 'Ahmed ClearPath 350 Implant', 'description': 'Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.18', 'spread': '25.86', 'groupId': 'OG000'}, {'value': '25.96', 'spread': '57.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.603', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Year 1', 'description': 'Pachymetry is an ophthalmological test that measures the thickness of the cornea.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at both timepoints.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire', 'timeFrame': 'Year 1', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life, as Measured by Glaucoma Symptom Scale', 'timeFrame': 'Year 1', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Quality of Life, as Measured by Glaucoma Utility Index', 'timeFrame': 'Year 1', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Self-report Dysesthesia Scale Questionnaire', 'timeFrame': 'Baseline and Year 1', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Motility Exam (Hess Screen Test)', 'timeFrame': 'Baseline and Year 1', 'description': 'If patient is binocular', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Motility Exam (Worth 4-dot)', 'timeFrame': 'Baseline and Year 1', 'description': 'If patient is binocular', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Motility Exam (Stereo Test)', 'timeFrame': 'Baseline and Year 1', 'description': 'If patient is binocular', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Motility Exam (9 Gaze Photos)', 'timeFrame': 'Baseline and Year 1', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change in Retinal Nerve Fiber Layer (RNFL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baerveldt 350 Implant', 'description': 'Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.'}, {'id': 'OG001', 'title': 'Ahmed ClearPath 350 Implant', 'description': 'Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.81', 'spread': '9.58', 'groupId': 'OG000'}, {'value': '4.72', 'spread': '13.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.833', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Year 1', 'description': 'The retinal nerve fiber layer (RNFL) is formed by retinal ganglion cell axons, which collect the visual impulses that begin with the rods and cones.', 'unitOfMeasure': 'µm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data collected at both timepoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Baerveldt 350 Implant', 'description': 'Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.'}, {'id': 'FG001', 'title': 'Ahmed ClearPath 350 Implant', 'description': 'Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '37', 'numSubjects': '37'}, {'groupId': 'FG001', 'numUnits': '39', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '33', 'numSubjects': '33'}, {'groupId': 'FG001', 'numUnits': '39', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '4'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'eyes', 'recruitmentDetails': 'Participants were recruited from the Duke Eye Center (Durham, NC, USA) and its satellite locations from December 2020 to June 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Baerveldt 350 Implant', 'description': 'Baerveldt 350 implant: The Baerveldt implant is an FDA-approved silicone, non-valved implant.'}, {'id': 'BG001', 'title': 'Ahmed ClearPath 350 Implant', 'description': 'Ahmed ClearPath 350 implant: The Ahmed ClearPath is a non-valved glaucoma drainage device.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.2', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '69.6', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '70.4', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-05-10', 'size': 390725, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-05T13:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2020-07-09', 'resultsFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-30', 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire', 'timeFrame': 'Year 1'}, {'measure': 'Quality of Life, as Measured by Glaucoma Symptom Scale', 'timeFrame': 'Year 1'}, {'measure': 'Quality of Life, as Measured by Glaucoma Utility Index', 'timeFrame': 'Year 1'}, {'measure': 'Change in Self-report Dysesthesia Scale Questionnaire', 'timeFrame': 'Baseline and Year 1'}, {'measure': 'Change in Motility Exam (Hess Screen Test)', 'timeFrame': 'Baseline and Year 1', 'description': 'If patient is binocular'}, {'measure': 'Change in Motility Exam (Worth 4-dot)', 'timeFrame': 'Baseline and Year 1', 'description': 'If patient is binocular'}, {'measure': 'Change in Motility Exam (Stereo Test)', 'timeFrame': 'Baseline and Year 1', 'description': 'If patient is binocular'}, {'measure': 'Change in Motility Exam (9 Gaze Photos)', 'timeFrame': 'Baseline and Year 1'}], 'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP)', 'timeFrame': 'Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1'}, {'measure': 'Number of Participants Who Experienced a Complication', 'timeFrame': 'Up to Year 1'}], 'secondaryOutcomes': [{'measure': 'Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1'}, {'measure': 'Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)', 'timeFrame': 'Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1'}, {'measure': 'Change in Humphrey Visual Field (HVF)', 'timeFrame': 'Baseline and Year 1', 'description': 'The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive value indicates an increase in visual field while a negative value indicates a decrease.'}, {'measure': 'Change in Thickness of the Cornea as Measured by Pachymetry', 'timeFrame': 'Baseline and Year 1', 'description': 'Pachymetry is an ophthalmological test that measures the thickness of the cornea.'}, {'measure': 'Change in Retinal Nerve Fiber Layer (RNFL)', 'timeFrame': 'Baseline and Year 1', 'description': 'The retinal nerve fiber layer (RNFL) is formed by retinal ganglion cell axons, which collect the visual impulses that begin with the rods and cones.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Baerveldt 350 implant', 'Ahmed ClearPath implant'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women with age at screening ≥ 18 years and ≤ 90 years\n* Inadequately controlled glaucoma\n* Valve-less aqueous shunt as the planned surgical procedure\n* Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic glaucoma with a previous failed trabeculectomy or other intraocular surgery included.\n* Primary tubes included\n* Investigators to recruit consecutively all eligible patients from their clinics.\n* Superotemporal or inferonasal placement of the tube\n* Capable and willing to provide consent\n\nExclusion Criteria:\n\n* NLP\n* Unable/unwilling to provide informed consent\n* Unavailable for regular follow up\n* Previous cyclodestructive procedure\n* Prior scleral buckling procedure or other external impediment to supratemporal drainage device implantation\n* Presence of silicone oil\n* Vitreous in the anterior chamber sufficient to require a vitrectomy\n* Uveitic glaucoma\n* Neovascular glaucoma\n* Nanophthalmos\n* Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure\n* Procedure combined with other surgery\n* Any abnormality other than glaucoma in the study eye that could affect tonometry.'}, 'identificationModule': {'nctId': 'NCT04468633', 'briefTitle': 'The Baerveldt Versus ClearPath Comparison Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'The Baerveldt Versus ClearPath Comparison Study', 'orgStudyIdInfo': {'id': 'PRO00105781'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Baerveldt 350 implant', 'interventionNames': ['Device: Baerveldt 350 implant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ahmed ClearPath 350 implant', 'interventionNames': ['Device: Ahmed ClearPath 350 implant']}], 'interventions': [{'name': 'Baerveldt 350 implant', 'type': 'DEVICE', 'description': 'The Baerveldt implant is an FDA-approved silicone, non-valved implant.', 'armGroupLabels': ['Baerveldt 350 implant']}, {'name': 'Ahmed ClearPath 350 implant', 'type': 'DEVICE', 'description': 'The Ahmed ClearPath is a non-valved glaucoma drainage device.', 'armGroupLabels': ['Ahmed ClearPath 350 implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Eye Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Leon Herndon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}