Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-03-10 @ 9:06 PM
Study NCT ID:
NCT01886456
Status:
UNKNOWN
Last Update Posted:
2013-06-25
First Post:
2013-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients
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'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-06-24', 'studyFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2013-06-24', 'lastUpdatePostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure 6 months after Intervention', 'timeFrame': '6 months'}]}, 'conditionsModule': {'conditions': ['Open Angle Glaucoma,', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '35943114', 'type': 'DERIVED', 'citation': 'Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of patterned laser trabeculoplasty (PLT) compared to selective laser trabeculoplasty (SLT) on intraocular pressure (IOP) in treatment naiv patients suffering from open-angle glaucoma or ocular hypertension.\n\nValues for IOP will be measured at baseline, 1 day and 1 month post-interventional as well as 2, 3, 6, 9, 12, 18 and 24 months after treatment.\n\n* Trial with medical device'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Intraocular pressure (treatment naiv or after 4 weeks wash-out phase) \\> 21 mm Hg\n* visible angle structures over 360° on gonioscopy\n* age = 18 years\n\nExclusion criteria:\n\n* Intraocular Inflammation\n* patients who underwent refractive corneal surgery for any reason or who underwent ocular surgery to reduce intraocular pressure (e.g. trabeculectomy)\n* monocle situation\n* anterior chamber lenses (incl. iris claw)\n* secondary glaucoma (with the exception of pseudoexfoliation and pigment dispersion)'}, 'identificationModule': {'nctId': 'NCT01886456', 'briefTitle': 'IOP Lowering Effect of PLT Versus SLT in Naiv OAG Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Effect of Patterned Laser Trabeculoplasty on Intraocular Pressure Compared to Selective Laser Trabeculoplasty in Treatment Naiv Patients Suffering From Open-angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': '14.1.2013_KEK ZH 2012-0422'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PLT', 'description': 'patients treated with patterned laser trabeculoplasty', 'interventionNames': ['Device: Laser trabeculoplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLT', 'description': 'patients treated with selective laser trabeculoplasty', 'interventionNames': ['Device: Laser trabeculoplasty']}], 'interventions': [{'name': 'Laser trabeculoplasty', 'type': 'DEVICE', 'armGroupLabels': ['PLT', 'SLT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Ophthalmology Clinic', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Gregor Jaggi, MD', 'role': 'CONTACT', 'email': 'gregor.jaggi@usz.ch'}, {'name': 'Christoph Kniestedt, MD', 'role': 'CONTACT', 'email': 'christoph.kniestedt@usz.ch'}], 'overallOfficials': [{'name': 'Christoph Kniestedt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Ophthalmology Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}