Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-02 @ 11:37 AM
Study NCT ID:
NCT05529966
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2022-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing NGENUITY vs Conventional Microscope in a New Hydrus User
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'christyr@stanford.edu', 'phone': '650-725-5743', 'title': 'Robert T. Chang, MD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional Microscope', 'description': 'Participants randomized to the use of a conventional microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NGENUITY', 'description': 'Participants randomized to the use of a NGENUITY microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Conventional Microscope (Re-randomized)', 'description': 'Participants who had a procedure for their second eye were re-randomized to use of a conventional microscope for the procedure.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'NGENUITY (Re-randomized)', 'description': 'Participants who had a procedure for their second eye were re-randomized to use of the NGENUITY microscope for the procedure.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Microscope', 'description': 'Conventional microscope used during micro-stent placement.'}, {'id': 'OG001', 'title': 'NGENUITY', 'description': 'NGENUITY microscope used during micro-stent placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.55', 'spread': '1.36', 'groupId': 'OG000'}, {'value': '3.06', 'spread': '2.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45490734', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 hour', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Participants/eyes evaluable for primary and secondary outcome measure analysis'}, {'type': 'SECONDARY', 'title': 'Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Microscope', 'description': 'Conventional microscope used during micro-stent placement.'}, {'id': 'OG001', 'title': 'NGENUITY', 'description': 'NGENUITY microscope used during micro-stent placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.92376110', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 hour', 'unitOfMeasure': 'piercing', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Participants/eyes evaluable for primary and secondary outcome measure analysis'}, {'type': 'SECONDARY', 'title': 'Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Microscope', 'description': 'Conventional microscope used during micro-stent placement.'}, {'id': 'OG001', 'title': 'NGENUITY', 'description': 'NGENUITY microscope used during micro-stent placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.14', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '0.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.94342221', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 hour', 'unitOfMeasure': 'Number of Anterior Chamber Entries', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Participants/eyes evaluable for primary and secondary outcome measure analysis'}, {'type': 'SECONDARY', 'title': 'Number of Microscope Focus or Position Readjustments Needed During Stent Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Microscope', 'description': 'Conventional microscope used during micro-stent placement.'}, {'id': 'OG001', 'title': 'NGENUITY', 'description': 'NGENUITY microscope used during micro-stent placement.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.43', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '1.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.38902793', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 hour', 'unitOfMeasure': 'Number of Focus/Microscope adjustments', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Participants/eyes evaluable for primary and secondary outcome measure analysis'}, {'type': 'SECONDARY', 'title': 'Change in Attending Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Microscope', 'description': 'Conventional microscope used during micro-stent placement.'}, {'id': 'OG001', 'title': 'NGENUITY', 'description': 'NGENUITY microscope used during micro-stent placement.'}], 'classes': [{'title': 'Comfort', 'categories': [{'measurements': [{'value': '3.14', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '3.93', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Visibility', 'categories': [{'measurements': [{'value': '3.57', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Image Quality', 'categories': [{'measurements': [{'value': '3.14', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.74', 'groupId': 'OG001'}]}]}, {'title': 'Focus', 'categories': [{'measurements': [{'value': '3.14', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Depth Perception', 'categories': [{'measurements': [{'value': '2.93', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Staff Engagement', 'categories': [{'measurements': [{'value': '3.36', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Teaching', 'categories': [{'measurements': [{'value': '3.29', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'En Face Confidence', 'categories': [{'measurements': [{'value': '3.43', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '4.07', 'spread': '0.96', 'groupId': 'OG001'}]}]}, {'title': 'Hydrus Placement Confidence', 'categories': [{'measurements': [{'value': '3.71', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Scope Preference (1 = 3D.)', 'categories': [{'measurements': [{'value': '2.71', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '1.80', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.00424940', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni 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't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.00000028', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Depth Perception score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.00112148', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Staff Engagement score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '00000951', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Teaching score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.03493564', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of En Face Confidence score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.12895248', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Hydrus Placement Confidence score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.00279611', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Scope Preference score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 minutes', 'description': 'Providers rate their comfort, visibility, image quality, focus, depth perception, staff engagement, teaching and level of confidence in using the system and system performance. Ratings are on a Likert scale of 1 to 5. Higher scores correspond to excellent ratings, higher confidence in using the system, and better system performance; for Scope Preference only, lower numbers (either group) correspond to a preference for NGenuity visualization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Participants/eyes evaluable for primary and secondary outcome measure analysis'}, {'type': 'SECONDARY', 'title': 'Change in Fellow Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional Microscope', 'description': 'Conventional microscope used during micro-stent placement.'}, {'id': 'OG001', 'title': 'NGENUITY', 'description': 'NGENUITY microscope used during micro-stent placement.'}], 'classes': [{'title': 'Comfort', 'categories': [{'measurements': [{'value': '4.21', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '4.20', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Visibility', 'categories': [{'measurements': [{'value': '4.21', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Image Quality', 'categories': [{'measurements': [{'value': '4.21', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Focus', 'categories': [{'measurements': [{'value': '3.93', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '4.40', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': 'Depth Perception', 'categories': [{'measurements': [{'value': '4.29', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '4.73', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Staff Engagement', 'categories': [{'measurements': [{'value': '3.57', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '4.73', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Teaching', 'categories': [{'measurements': [{'value': '4.00', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '4.80', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'En Face Confidence', 'categories': [{'measurements': [{'value': '4.00', 'spread': '0.88', 'groupId': 'OG000'}, {'value': '4.33', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Hydrus Placement Confidence', 'categories': [{'measurements': [{'value': '4.29', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '0.83', 'groupId': 'OG001'}]}]}, {'title': 'Scope Preference (1 = 3D..)', 'categories': [{'measurements': [{'value': '3.00', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.959638658', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Comfort score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.213464715', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Visibility score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.213464715', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Image Quality score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.155899777', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Focus score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.055960023', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Depth Perception score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.000685499', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Staff Engagement score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.004526118', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Teaching score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.299921137', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of En Face Confidence score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.368082084', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Hydrus Placement Confidence score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}, {'pValue': '.015036417', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The a priori threshold for statistical significance after Bonferroni correction is \\< 0.002083333', 'groupDescription': 'Analysis of Scope Preference score', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Up to 5 minutes', 'description': 'Providers rate their comfort, visibility, image quality, focus, depth perception, staff engagement, teaching and level of confidence in using the system and system performance. Ratings are on a Likert scale of 1 to 5. Higher scores correspond to excellent ratings, higher confidence in using the system, and better system performance; for Scope Preference only, lower numbers (either group) correspond to a preference for NGenuity visualization.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Eyes', 'populationDescription': 'Participants/eyes evaluable for primary and secondary outcome measure analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional Microscope', 'description': 'Participants randomized to the use of a conventional microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope.'}, {'id': 'FG001', 'title': 'NGENUITY', 'description': 'Participants randomized to the use of a NGENUITY microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope.'}, {'id': 'FG002', 'title': 'Conventional Microscope (Re-randomized)', 'description': 'Participants who had a procedure for their second eye were re-randomized to use of a conventional microscope for the procedure.'}, {'id': 'FG003', 'title': 'NGENUITY (Re-randomized)', 'description': 'Participants who had a procedure for their second eye were re-randomized to use of the NGENUITY microscope for the procedure.'}], 'periods': [{'title': 'First Eye', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '14'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '14'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Stent Placement Could Not be Performed', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Had Missing Data', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'Evaluable for Primary and Secondary Outcome Measure Analysis', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '12'}, {'groupId': 'FG001', 'numUnits': '13', 'numSubjects': '13'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '13', 'numSubjects': '13'}, {'groupId': 'FG001', 'numUnits': '13', 'numSubjects': '13'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Second Eye', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3'}]}, {'type': 'Randomized to Use of Opposite Microscope for Second Eye Procedure', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG003', 'numUnits': '2', 'numSubjects': '2'}]}, {'type': 'Evaluable for Primary and Secondary Outcome Measure Analysis', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG003', 'numUnits': '3', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Eyes', 'preAssignmentDetails': '32 participants signed informed consent, 28 were randomized to either study arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional Microscope', 'description': 'Participants randomized to the use of a conventional microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope.'}, {'id': 'BG001', 'title': 'NGENUITY', 'description': 'Participants randomized to the use of a NGENUITY microscope for the first eye procedure. Participants who had a procedure for their second eye were randomized again to either the conventional or NGENUITY microscope.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.6', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '76.1', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '75.9', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants/eyes evaluable for primary and secondary outcome measure analysis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-04', 'size': 279378, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-14T12:06', 'hasProtocol': True}, {'date': '2025-03-14', 'size': 103681, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-14T19:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2022-09-02', 'resultsFirstSubmitDate': '2025-03-20', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-20', 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of First Cannula in Until Satisfactory Stent Placement and Cannula Out', 'timeFrame': 'up to 1 hour'}], 'secondaryOutcomes': [{'measure': 'Number of Trabecular Meshwork Piercing Attempts Needed to Place Stent', 'timeFrame': 'up to 1 hour'}, {'measure': 'Number of Anterior Chamber Entry and Reentry Attempts During Stent Placement', 'timeFrame': 'up to 1 hour'}, {'measure': 'Number of Microscope Focus or Position Readjustments Needed During Stent Placement', 'timeFrame': 'up to 1 hour'}, {'measure': 'Change in Attending Questionnaire Score', 'timeFrame': 'Up to 5 minutes', 'description': 'Providers rate their comfort, visibility, image quality, focus, depth perception, staff engagement, teaching and level of confidence in using the system and system performance. Ratings are on a Likert scale of 1 to 5. Higher scores correspond to excellent ratings, higher confidence in using the system, and better system performance; for Scope Preference only, lower numbers (either group) correspond to a preference for NGenuity visualization.'}, {'measure': 'Change in Fellow Questionnaire Score', 'timeFrame': 'Up to 5 minutes', 'description': 'Providers rate their comfort, visibility, image quality, focus, depth perception, staff engagement, teaching and level of confidence in using the system and system performance. Ratings are on a Likert scale of 1 to 5. Higher scores correspond to excellent ratings, higher confidence in using the system, and better system performance; for Scope Preference only, lower numbers (either group) correspond to a preference for NGenuity visualization.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'To compare the potential efficiency and educational value of using NGENUITY (3D camera system, FDA approved for this indication) vs the conventional microscope for Hydrus microstent placement by new users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with mild to moderate primary open angle glaucoma as defined by AGS with visually significant age-related cataract undergoing uncomplicated cataract surgery and Hydrus microstent\n* Either eye or both eyes may participate\n\nExclusion Criteria:\n\n* Lack of patient cooperation severely affecting ability to place stent with any visualization technique\n* Angle abnormalities including PAS in nasal quadrant\n* Unable to properly visualize the angle due to complicated cataract surgery'}, 'identificationModule': {'nctId': 'NCT05529966', 'briefTitle': 'Comparing NGENUITY vs Conventional Microscope in a New Hydrus User', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparing NGENUITY vs Conventional Microscope in a New Hydrus User', 'orgStudyIdInfo': {'id': '66363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NGENUITY', 'description': 'Research fellow participants utilize NGENUITY during micro-stent placement', 'interventionNames': ['Device: NGENUITY']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional microscope', 'description': 'Research fellow participants utilize conventional microscope during micro-stent placement', 'interventionNames': ['Device: Conventional microscope']}], 'interventions': [{'name': 'NGENUITY', 'type': 'DEVICE', 'description': 'Device for 3-D viewing during placement of micro-stent placement.', 'armGroupLabels': ['NGENUITY']}, {'name': 'Conventional microscope', 'type': 'DEVICE', 'description': 'Device for stereoscopic viewing during placement of micro-stent placement.', 'armGroupLabels': ['Conventional microscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Byers Eye Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Robert T Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alcon Research', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Ophthalmology', 'investigatorFullName': 'Robert T. Chang, MD', 'investigatorAffiliation': 'Stanford University'}}}}