Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-28 @ 9:30 AM
Study NCT ID:
NCT01263561
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2010-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
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'}]}, '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': 'y.buys@utoronto.ca', 'phone': '416-603-5682', 'title': 'Dr Yvonne Buys', 'organization': 'Department of Ophthalmology and Vision Sciences, University of Toronto'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Trabeculectomy', 'description': 'trabeculectomy filtering surgery\n\ntrabeculectomy: trabeculectomy filtering surgery', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ExPRESS', 'description': 'ExPRESS miniature glaucoma drainage device\n\nExPRESS shunt: ExPRESS miniature glaucoma drainage device', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trabeculectomy', 'description': 'trabeculectomy filtering surgery\n\ntrabeculectomy: trabeculectomy filtering surgery'}, {'id': 'OG001', 'title': 'ExPRESS', 'description': 'ExPRESS miniature glaucoma drainage device\n\nExPRESS shunt: ExPRESS miniature glaucoma drainage device'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '4.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.85', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'A sample size calculation determined that 52 eyes were required to detect a 2.0 mmHg IOP difference with a power of 80%.'}], 'paramType': 'MEAN', 'timeFrame': '1 year post surgery', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trabeculectomy', 'description': 'trabeculectomy filtering surgery\n\ntrabeculectomy: trabeculectomy filtering surgery'}, {'id': 'OG001', 'title': 'ExPRESS', 'description': 'ExPRESS miniature glaucoma drainage device\n\nExPRESS shunt: ExPRESS miniature glaucoma drainage device'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.24', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Kaplan Meier', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Power calculation only for main outcome measure of IOP.'}], 'paramType': 'NUMBER', 'timeFrame': '1 year post surgery', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trabeculectomy', 'description': 'trabeculectomy filtering surgery\n\ntrabeculectomy: trabeculectomy filtering surgery'}, {'id': 'OG001', 'title': 'ExPRESS', 'description': 'ExPRESS miniature glaucoma drainage device\n\nExPRESS shunt: ExPRESS miniature glaucoma drainage device'}], 'classes': [{'title': 'Early transient hypotony', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Late transient hypotony', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'encapsulated bleb', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'choroidal effusion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'early bleb leak', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'membrane over ExPRESS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ExPRESS eroding through sclera', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Total # of subjects with a complication', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.80', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Above p is for number of subjects with any complication. P values above 0.05 are considered statistically insignificant in this study.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Power calculation only performed for main outcome measure of IOP.'}], 'paramType': 'NUMBER', 'timeFrame': '1 year post surgery', 'description': 'Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trabeculectomy', 'description': 'trabeculectomy filtering surgery\n\ntrabeculectomy: trabeculectomy filtering surgery'}, {'id': 'FG001', 'title': 'ExPRESS', 'description': 'ExPRESS miniature glaucoma drainage device\n\nExPRESS shunt: ExPRESS miniature glaucoma drainage device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Trabeculectomy', 'description': 'trabeculectomy filtering surgery\n\ntrabeculectomy: trabeculectomy filtering surgery'}, {'id': 'BG001', 'title': 'ExPRESS', 'description': 'ExPRESS miniature glaucoma drainage device\n\nExPRESS shunt: ExPRESS miniature glaucoma drainage device'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.9', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '62', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'intraocular pressure', 'classes': [{'categories': [{'measurements': [{'value': '22', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '22.6', 'spread': '10.2', 'groupId': 'BG001'}, {'value': '22.3', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'glaucoma medications', 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.3', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '.9', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '1.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'number of medications', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'visual acuity', 'classes': [{'categories': [{'measurements': [{'value': '.48', 'spread': '.6', 'groupId': 'BG000'}, {'value': '.42', 'spread': '.6', 'groupId': 'BG001'}, {'value': '.44', 'spread': '.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'logMAR', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-07', 'studyFirstSubmitDate': '2010-12-14', 'resultsFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2010-12-17', 'lastUpdatePostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-07', 'studyFirstPostDateStruct': {'date': '2010-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure', 'timeFrame': '1 year post surgery'}, {'measure': 'Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication', 'timeFrame': '1 year post surgery'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '1 year post surgery', 'description': 'Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma', 'filtration surgery', 'trabeculectomy', 'ExPRESS shunt'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '36912740', 'type': 'DERIVED', 'citation': 'Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.'}, {'pmid': '26674779', 'type': 'DERIVED', 'citation': 'Gonzalez-Rodriguez JM, Trope GE, Drori-Wagschal L, Jinapriya D, Buys YM. Comparison of trabeculectomy versus Ex-PRESS: 3-year follow-up. Br J Ophthalmol. 2016 Sep;100(9):1269-73. doi: 10.1136/bjophthalmol-2015-307161. Epub 2015 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome: IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from baseline without medication or additional glaucoma surgery and qualified success defined as IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.', 'detailedDescription': 'Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 to 85\n* open-angle glaucoma uncontrolled medically\n* intraocular pressure ≥ 18 mmHg\n* trabeculectomy as the planned surgical procedure\n\nExclusion Criteria:\n\n* any previous ocular incisional surgery with the exception of previous clear\n* cornea cataract surgery\n* uveitis\n* vitreous present in anterior chamber\n* patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits'}, 'identificationModule': {'nctId': 'NCT01263561', 'briefTitle': 'Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy', 'orgStudyIdInfo': {'id': '07-0888-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'trabeculectomy', 'description': 'trabeculectomy filtering surgery', 'interventionNames': ['Procedure: trabeculectomy']}, {'type': 'EXPERIMENTAL', 'label': 'ExPRESS', 'description': 'ExPRESS miniature glaucoma drainage device', 'interventionNames': ['Procedure: ExPRESS shunt']}], 'interventions': [{'name': 'ExPRESS shunt', 'type': 'PROCEDURE', 'description': 'ExPRESS miniature glaucoma drainage device', 'armGroupLabels': ['ExPRESS']}, {'name': 'trabeculectomy', 'type': 'PROCEDURE', 'description': 'trabeculectomy filtering surgery', 'armGroupLabels': ['trabeculectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Graham E Trope, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Toronto'}, {'name': 'Yvonne M Buys, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, FRCSC; Professor', 'investigatorFullName': 'Yvonne Buys', 'investigatorAffiliation': 'University of Toronto'}}}}