Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-03-24 @ 12:29 PM
Study NCT ID:
NCT00551395
Status:
TERMINATED
Last Update Posted:
2015-09-23
First Post:
2007-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2007-10-29', 'studyFirstSubmitQcDate': '2007-10-30', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraocular pressure lowering', 'timeFrame': '1 month following procedure'}], 'secondaryOutcomes': [{'measure': 'intraocular pressure lowering', 'timeFrame': '3, 6, 12 and 24 months following procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma', 'laser', 'trabeculoplasty'], 'conditions': ['Glaucoma']}, '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': 'This study will evaluate the effect of the timing of treatment completion in two-staged selective laser trabeculoplasty therapy on intraocular pressure lowering effect.', 'detailedDescription': 'SLT therapy is used as an IOP lowering agent in patients with glaucoma. It is unknown whether the timing of a 2-staged approach to the laser therapy will result in better IOP lowering effect.\n\nThis study will evaluate the timing (early vs. late completion of SLT therapy) and determined the IOP lowering effect following the interventions.\n\nArm 1: Early Completion SLT\n\n180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees on Day 2\n\nArm 2: Late Completion SLT\n\n180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees at the 1 month follow up visit.\n\nPrimary Outcome: IOP (mmHg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age\n* primary open angle glaucoma or pseudoexfoliation glaucoma\n\nExclusion Criteria:\n\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT00551395', 'briefTitle': 'Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion', 'orgStudyIdInfo': {'id': 'RC-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLT Early Completion (Arm 1)', 'description': 'Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degree on Day 2', 'interventionNames': ['Procedure: selective laser trabeculoplasty - early completion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SLT Late Completion (Arm 2)', 'description': 'Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degrees at 1 month follow up appointment.', 'interventionNames': ['Procedure: Selective laser trabeculoplasty - late completion']}], 'interventions': [{'name': 'selective laser trabeculoplasty - early completion', 'type': 'PROCEDURE', 'description': '180 degrees of laser on day 1 and other 180 degrees on day 2.', 'armGroupLabels': ['SLT Early Completion (Arm 1)']}, {'name': 'Selective laser trabeculoplasty - late completion', 'type': 'PROCEDURE', 'description': '180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point.', 'armGroupLabels': ['SLT Late Completion (Arm 2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 5G2', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Hotel Dieu Hospital & Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Robert J Campbell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University, Kingston, Canada"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Robert Campbell', 'investigatorAffiliation': "Queen's University"}}}}