Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-02 @ 11:38 AM
Study NCT ID:
NCT05126069
Status:
COMPLETED
Last Update Posted:
2021-11-18
First Post:
2021-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ab Interno Gelatin Microstent With MMC vs. Trabeculectomy With MMC: 3 Year Retrospective Cohort Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-17', 'studyFirstSubmitDate': '2021-11-05', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to failure', 'timeFrame': 'up to 3 years', 'description': 'defined as intraocular pressure (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic maneuvers (including needling)'}], 'secondaryOutcomes': [{'measure': 'included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations', 'timeFrame': 'up to 3 years', 'description': 'Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Xen', 'Ab Interno Gelatin Microstent'], 'conditions': ['Filtering Surgery', 'Trabeculectomy']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'J Liu, M Schlenker, I Ahmed. Long-Term Efficacy & Safety of Standalone Ab Interno Gelatin Microstent Implantation with MMC Vs. Trabeculectomy with MMC: 3 Year Follow-up. ASCRS Conference 2021.'}], 'seeAlsoLinks': [{'url': 'https://ascrs.org/clinical-education/abstracts/2021/longterm-efficacy--safety-of-standalone-ab-interno-gelatin-microstent-implantation-with-mmc-vs-trabe', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To compare 3-year post-operative efficacy and safety of standalone ab interno gelatin microstent (Xen45®) versus trabeculectomy.', 'detailedDescription': 'This is a single-center retrospective cohort study. Patients included were consecutive patients from June 2012 - July 2017 who received standalone Xen45® or standalone trabeculectomy. The primary outcome was time to failure, defined as intraocular pressure (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic maneuvers (including needling). Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Glaucoma patients who received received a gelatin stent 45 with MMC (mitomycin C) or a trabeculectomy with MMC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 30-90\n* primary or pigmentary/pseudoexfoliative open angle, primary closed angle, narrow angle or combined mechanism glaucoma\n* IOP of 18-40 on maximum tolerated medical therapy\n* received a gelatin stent 45 with MMC or a trabeculectomy with MMC at Prism Eye Institute from June 2012 to July 2018, and have at least 3 years of follow-up.\n\nExclusion Criteria:\n\n* Other forms of glaucoma\n* prior incisional glaucoma surgery\n* CPC\n* combined surgery (cataract, cornea, or retina)\n* prior corneal graft (PKP, DALK, DSAEK, DMEK)'}, 'identificationModule': {'nctId': 'NCT05126069', 'acronym': 'LongGVT', 'briefTitle': 'Ab Interno Gelatin Microstent With MMC vs. Trabeculectomy With MMC: 3 Year Retrospective Cohort Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Prism Eye Institute'}, 'officialTitle': 'Longitudinal Gelatin Stent vs. Trabeculectomy (LongGVT Study): Ab Interno Gelatin Stent With Mitomycin C Versus Trabeculectomy With Mitomycin C: a Retrospective Cohort Analysis', 'orgStudyIdInfo': {'id': '2018-10376'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standalone Xen45', 'description': 'consecutive patients from June 2012 - July 2017 who received standalone Xen45®', 'interventionNames': ['Device: Ab interno gelatin microstent']}, {'label': 'Standalone Trabeculectomy', 'description': 'consecutive patients from June 2012 - July 2017 who received standalone trabeculectomy', 'interventionNames': ['Procedure: Trabeculectomy']}], 'interventions': [{'name': 'Ab interno gelatin microstent', 'type': 'DEVICE', 'description': 'Ab interno gelatin microstent', 'armGroupLabels': ['Standalone Xen45']}, {'name': 'Trabeculectomy', 'type': 'PROCEDURE', 'description': 'Trabeculectomy', 'armGroupLabels': ['Standalone Trabeculectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L6H 0J8', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Prism Eye Institute', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prism Eye Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Innovation Officer', 'investigatorFullName': 'Iqbal Ahmed', 'investigatorAffiliation': 'Prism Eye Institute'}}}}