Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-03-19 @ 7:47 AM
Study NCT ID:
NCT01883856
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2013-06-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pan9c@virginia.edu', 'phone': '4349821086', 'title': 'Peter A. Netland, MD, PhD', 'organization': 'University of Virginia'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Silicone Plate Ahmed Glaucoma Valve', 'description': 'Silicone plate Ahmed Glaucoma Valve\n\nSilicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 13, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Porous Plate Ahmed Glaucoma Valve', 'description': 'Porous Plate Ahmed Glaucoma Valve\n\nPorous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 15, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypertensive phase', 'notes': 'Hypertensive phase was defined as intraocular pressure more than 21 mmHg during the first three months postoperatively.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Plate Ahmed Glaucoma Valve', 'description': 'Silicone plate Ahmed Glaucoma Valve\n\nSilicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.'}, {'id': 'OG001', 'title': 'Porous Plate Ahmed Glaucoma Valve', 'description': 'Porous Plate Ahmed Glaucoma Valve\n\nPorous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.60', 'spread': '4.69', 'groupId': 'OG000'}, {'value': '17.94', 'spread': '10.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Anti-Glaucoma Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Plate Ahmed Glaucoma Valve', 'description': 'Silicone plate Ahmed Glaucoma Valve\n\nSilicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.'}, {'id': 'OG001', 'title': 'Porous Plate Ahmed Glaucoma Valve', 'description': 'Porous Plate Ahmed Glaucoma Valve\n\nPorous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.64', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '1.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months.', 'unitOfMeasure': 'glaucoma medications', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Surgical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Silicone Plate Ahmed Glaucoma Valve', 'description': 'Silicone plate Ahmed Glaucoma Valve\n\nSilicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.'}, {'id': 'OG001', 'title': 'Porous Plate Ahmed Glaucoma Valve', 'description': 'Porous Plate Ahmed Glaucoma Valve\n\nPorous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Surgical success in the porous plate group as compared to the silicone plate group at 12 months. Surgical success was defined as intraocular pressure of ≤5 mmHg or ≥21 mmHg (with or without glaucoma medications), with no loss of light perception, and no additional glaucoma procedures.', 'unitOfMeasure': 'surgical success', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Silicone Plate Ahmed Glaucoma Valve', 'description': 'Silicone plate Ahmed Glaucoma Valve\n\nSilicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.'}, {'id': 'FG001', 'title': 'Porous Plate Ahmed Glaucoma Valve', 'description': 'Porous Plate Ahmed Glaucoma Valve\n\nPorous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Silicone Plate Ahmed Glaucoma Valve', 'description': 'Silicone plate Ahmed Glaucoma Valve\n\nSilicone plate Ahmed Glaucoma Valve (Model FP7): This intervention is conducted as a surgical intervention.'}, {'id': 'BG001', 'title': 'Porous Plate Ahmed Glaucoma Valve', 'description': 'Porous Plate Ahmed Glaucoma Valve\n\nPorous Plate Ahmed Glaucoma Valve (Model M4): This intervention is conducted as a surgical intervention.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.7', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '67.0', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '67.3', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity', 'categories': [{'title': 'African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Caucasian', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Mixed Race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pre-operative intraocular pressure', 'classes': [{'categories': [{'measurements': [{'value': '29.91', 'spread': '6.55', 'groupId': 'BG000'}, {'value': '33.79', 'spread': '10.54', 'groupId': 'BG001'}, {'value': '31.85', 'spread': '8.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-25', 'size': 193820, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-25T13:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2013-06-18', 'resultsFirstSubmitDate': '2020-08-25', 'studyFirstSubmitQcDate': '2013-06-18', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-25', 'studyFirstPostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intraocular Pressure', 'timeFrame': '12 months', 'description': 'The primary endpoint is the mean intraocular pressure in the porous plate group as compared to the silicone plate group.'}], 'secondaryOutcomes': [{'measure': 'Anti-Glaucoma Medications', 'timeFrame': '12 months', 'description': 'The mean number of anti-glaucoma medications in the porous plate group as compared to the silicone plate group at 12 months.'}, {'measure': 'Surgical Success', 'timeFrame': '12 months', 'description': 'Surgical success in the porous plate group as compared to the silicone plate group at 12 months. Surgical success was defined as intraocular pressure of ≤5 mmHg or ≥21 mmHg (with or without glaucoma medications), with no loss of light perception, and no additional glaucoma procedures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Refractory Glaucoma', 'Intractable Glaucoma', 'Primary Open Angle Glaucoma', 'Neovascular Glaucoma'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '32765127', 'type': 'RESULT', 'citation': 'Roa TM, Netland PA, Costa VP, Sarkisian SR Jr, Al-Aswad LA, Moster MR, Ahmed IIK. Comparison of Silicone- and Porous-Plate Ahmed Glaucoma Valves. Med Devices (Auckl). 2020 Jul 16;13:213-221. doi: 10.2147/MDER.S258498. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32765127/', 'label': 'Study results indexed on Pub Med'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma.', 'detailedDescription': 'The purpose of this study is to evaluate and compare the clinical outcomes after implantation of the porous plate (polyethylene) (Model M4) Ahmed Glaucoma Valve with the silicone plate Ahmed Glaucoma Valve (Model FP7) in participants with refractory glaucoma. Participation will last for 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female of any race ≥ 18 years and ≤ 80 years of age.\n* Diagnosis of intractable glaucoma in the study eye, with the exception of silicone oil endotamponade induced glaucoma, which has not responded to conventional medical and surgical therapy.\n* Elevated intraocular pressure \\> 21 mmHg in the study eye. Two consecutive measurements using Goldmann Applanation Tonometry will be obtained and the mean of those two measurements will be considered the subject's baseline intraocular pressure.\n* Subject is a candidate for surgery in the study eye with a glaucoma drainage device.\n* Subject is willing and able to sign the informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of silicone oil endotamponade induced glaucoma in the study eye.\n* History of prior drainage implant surgery in the study eye.\n* History of cyclophotocoagulation of the study eye.\n* Pregnancy.\n* Prisoner."}, 'identificationModule': {'nctId': 'NCT01883856', 'briefTitle': 'Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Comparison of Silicone and Porous Plate Ahmed Glaucoma Valves', 'orgStudyIdInfo': {'id': '16051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Silicone Plate Ahmed Glaucoma Valve', 'description': 'Silicone plate Ahmed Glaucoma Valve', 'interventionNames': ['Device: Silicone plate Ahmed Glaucoma Valve (Model FP7)']}, {'type': 'EXPERIMENTAL', 'label': 'Porous Plate Ahmed Glaucoma Valve', 'description': 'Porous Plate Ahmed Glaucoma Valve', 'interventionNames': ['Device: Porous Plate Ahmed Glaucoma Valve (Model M4)']}], 'interventions': [{'name': 'Silicone plate Ahmed Glaucoma Valve (Model FP7)', 'type': 'DEVICE', 'description': 'This intervention is conducted as a surgical intervention.', 'armGroupLabels': ['Silicone Plate Ahmed Glaucoma Valve']}, {'name': 'Porous Plate Ahmed Glaucoma Valve (Model M4)', 'type': 'DEVICE', 'description': 'This intervention is conducted as a surgical intervention.', 'armGroupLabels': ['Porous Plate Ahmed Glaucoma Valve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Peter A Netland, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Described in study results - https://pubmed.ncbi.nlm.nih.gov/32765127/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Netland, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'New World Medical, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chair, Department of Ophthalmology', 'investigatorFullName': 'Peter Netland, MD', 'investigatorAffiliation': 'University of Virginia'}}}}