Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-03-01 @ 6:29 AM
Study NCT ID:
NCT02434250
Status:
COMPLETED
Last Update Posted:
2017-06-20
First Post:
2015-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selective Laser Trabeculoplasty After Failed Phacoemulsification With Eximer Laser Trabeculectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-19', 'studyFirstSubmitDate': '2015-01-29', 'studyFirstSubmitQcDate': '2015-04-29', 'lastUpdatePostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy intraocular pressure', 'timeFrame': 't0 and t=12 month', 'description': 'Efficacy as measured by decrease in intraocular pressure from baseline'}, {'measure': 'Efficacy medication', 'timeFrame': 't0 and t=12 month', 'description': 'as measured by decrease in number of used hypotensive medications'}], 'secondaryOutcomes': [{'measure': 'Efficacy visual acuity', 'timeFrame': 't0 and t=12 month', 'description': 'Efficacy as increase in best corrected visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Open angle glaucoma', 'Ocular hypertension', 'Cataract', 'Selective Laser Trabeculoplasty', 'Eximer Laser Trabeculectomy', 'Phacoemulsification Cataract Extraction'], 'conditions': ['Open Angle Glaucoma', 'Ocular Hypertension', 'Cataract']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a prior failed phacoemulsification and Eximer Laser Trabeculectomy.', 'detailedDescription': 'This study evaluates the efficacy of selective laser trabeculoplasty after a failed combined procedure of phacoemulsification cataract extraction with intraocular lens implantation plus Eximer Laser Trabeculectomy in open angle glaucoma or ocular hypertension. The success of SLT will be determined by the intraocular pressure and number of hypotensive drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of open angle glaucoma or ocular hypertension\n* and diagnosis of cataract\n\nExclusion Criteria:\n\n* diagnosis of angle closure glaucoma\n* any optic neuropathy other than glaucoma'}, 'identificationModule': {'nctId': 'NCT02434250', 'acronym': 'SLT', 'briefTitle': 'Selective Laser Trabeculoplasty After Failed Phacoemulsification With Eximer Laser Trabeculectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effectiveness of Selective Laser Trabeculoplasty (SLT) After Failed Phacoemulsification Cataract Extraction Combined With Eximer Laser Trabeculectomy (Phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension', 'orgStudyIdInfo': {'id': 'SLT after Phaco-ELT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLT arm', 'description': "Patient receiving 'Selective Laser Trabeculoplasty' (SLT) due to failed Phacoemulsification Cataract Extraction with Intraocular Lens Implantation combined with Eximer Laser Trabeculectomy (phaco-ELT) in Open Angle Glaucoma and Ocular Hypertension to control intraocular pressure and/or glaucoma progression.", 'interventionNames': ['Procedure: Selective Laser Trabeculoplasty']}], 'interventions': [{'name': 'Selective Laser Trabeculoplasty', 'type': 'PROCEDURE', 'description': 'Selective Laser Trabeculoplasty is a laser treatment procedure to enhance trabecular aequous humor outflow and thus decrease intraocular pressure.', 'armGroupLabels': ['SLT arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Department of Ophthalmology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Marc Toeteberg-Harms, MD, FEBO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UniversityHospital Zurich, Dept. of Ophthalmology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}