Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-01 @ 2:11 AM
Study NCT ID:
NCT04333433
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2020-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PRESERFLO® MicroShunt Extension Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edith.vandijkman@santen.com', 'phone': '+31683667357', 'title': 'Edith van Dijkman', 'organization': 'Santen, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.', 'description': 'Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.', 'eventGroups': [{'id': 'EG000', 'title': 'MicroShunt Treatment Group', 'description': 'Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device PRESERFLO® MicroShunt: Device surgically implanted', 'otherNumAtRisk': 217, 'deathsNumAtRisk': 217, 'otherNumAffected': 172, 'seriousNumAtRisk': 217, 'deathsNumAffected': 3, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Trabeculectomy Control Arm', 'description': 'Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Trabeculectomy: The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 47, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Worsening in the Visual Field Mean Deviation', 'notes': 'Confirmed Worsening in the Visual Field Mean Deviation (MD) ≥2.5dB compared to MD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 54, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased IOP Requiring Treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 57, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cataract Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss 2 or More Lines of BCVA', 'notes': 'Loss 2 or More Lines of BCVA on 2 Consecutive Standard Follow-ups 90 Days or more after Implantation (excluding Posterior Capsule Opacification, followed by post Nd: YAG Capsulotomy and improvement)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Posterior Capsule Opacification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleb Related Complications', 'notes': 'Bleb Related Complications e.g. cystic bleb, flat bleb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Encapsulated Bleb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotony', 'notes': 'Hypotony (IOP \\<6mmHg at any Time)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epiretinal Membrane', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meibomian Gland Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Choroidal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erosion of the Device through the Conjunctiva', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Central Retinal Artery Occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pseudophakic Bullous Keratopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Endothelial Cell Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Sight-threatening Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MicroShunt Treatment Group', 'description': 'Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device PRESERFLO® MicroShunt: Device surgically implanted'}, {'id': 'OG001', 'title': 'Trabeculectomy Control Arm', 'description': 'Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Trabeculectomy: The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 36 thru Month 60', 'description': 'Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Incidence of sight-threatening adverse events'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MicroShunt Treatment Group', 'description': 'Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device PRESERFLO® MicroShunt: Device surgically implanted'}, {'id': 'FG001', 'title': 'Trabeculectomy Control Arm', 'description': 'Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Trabeculectomy: The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': '2 PRESERFLO Early Exit 1 PRESERFLO PI decision 1 PRESERFLO Study Exit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This report presents data for 279 of subjects that completed the INN-005 Month 24 visit in the Phase II Pivotal Study who were enrolled in the INN-005 EXT study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MicroShunt Treatment Group', 'description': 'Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device PRESERFLO® MicroShunt: Device surgically implanted'}, {'id': 'BG001', 'title': 'Trabeculectomy Control Arm', 'description': 'Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Trabeculectomy: The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '255', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-16', 'size': 16131883, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-31T14:58', 'hasProtocol': True}, {'date': '2021-07-13', 'size': 578706, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-31T14:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 279}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2020-04-01', 'resultsFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-19', 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Sight-threatening Adverse Events', 'timeFrame': 'Month 36 thru Month 60', 'description': 'Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['POAG'], 'conditions': ['Primary Open-angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.', 'detailedDescription': 'The objective of this study is to evaluate the long-term safety of the PRESERFLO® MicroShunt in subjects with Primary Open-Angle Glaucoma who have completed their Month 24 Follow-Up Visit in the INN-005 clinical study, by collecting safety data through 5 years post-operative follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes all living subjects who have completed the Month 24 Follow-Up Visit of the INN-005 clinical study after randomization to either the PRESERFLO® MicroShunt treatment arm or the Trabeculectomy control arm, and who are willing and able to extend their study participation and return for up to three (3) additional annual follow-up visits through post-operative Month 60. Up to 629 subjects may be enrolled at up to 24 sites located in the United States and at up to 5 sites located in Europe', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028.\n2. Subject was randomized into the INN-005 study and received the PRESERFLO® MicroShunt device or trabeculectomy. (Subjects who have had the device explanted, or replaced with another device, may be included).\n3. Subject is willing and able to comply with all study requirements, including signing an informed consent form.\n\nExclusion Criteria:\n\n1\\. Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to enrollment for participation in this long-term follow-up study.'}, 'identificationModule': {'nctId': 'NCT04333433', 'briefTitle': 'PRESERFLO® MicroShunt Extension Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'InnFocus Inc.'}, 'officialTitle': 'A Prospective, Concurrent Controlled, Open-Label, Multicenter Clinical Study to Assess the Long-Term Safety of the PRESERFLO® MicroShunt in Subjects With Primary Open-Angle Glaucoma Who Have Completed Participation in the INN-005 Randomized Controlled Study.', 'orgStudyIdInfo': {'id': 'INN005 - EXT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MicroShunt treatment group', 'description': 'Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device', 'interventionNames': ['Device: PRESERFLO® MicroShunt']}, {'label': 'Trabeculectomy control arm', 'description': 'Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure', 'interventionNames': ['Procedure: Trabeculectomy']}], 'interventions': [{'name': 'PRESERFLO® MicroShunt', 'type': 'DEVICE', 'otherNames': ['InnFocus MicroShunt® Glaucoma Drainage System'], 'description': 'Device surgically implanted', 'armGroupLabels': ['MicroShunt treatment group']}, {'name': 'Trabeculectomy', 'type': 'PROCEDURE', 'description': 'The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.', 'armGroupLabels': ['Trabeculectomy control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Advance Eye Research Institute, LLC.', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vold Vision', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center Jules Stein Eye Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Davis Eye Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '06450', 'city': 'Meriden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Connecticut', 'geoPoint': {'lat': 41.53815, 'lon': -72.80704}}, {'zip': '83616', 'city': 'Eagle', 'state': 'Idaho', 'country': 'United States', 'facility': 'Intermountain Eye Center', 'geoPoint': {'lat': 43.69544, 'lon': -116.35401}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Eugene and Marilyn Glick Eye Institute', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66213', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Stiles Eye Care Excellence & Glaucoma Institute', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '55431', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Eye Consultants, PA', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear Infirmary of Mt. 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