Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-02-21 @ 10:00 PM
Study NCT ID:
NCT00981435
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2009-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Steroids After Laser Trabeculoplasty for Glaucoma
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': 'C025494', 'term': "1(beta)-D-arabinofuranosylcytosine-5'-diphosphate prednisolone"}, {'id': 'C009935', 'term': 'prednisolone acetate'}, {'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D004008', 'term': 'Diclofenac'}, {'id': 'D065346', 'term': 'Lubricant Eye Drops'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D054327', 'term': 'Lubricants'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mnunez1@stanford.edu', 'phone': '6507236995', 'title': 'Clinical Research Coordinator', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 12 weeks', 'description': 'Adverse events and serious adverse events were pre-defined and evaluated by examining physician at every study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Artificial Tears', 'description': 'Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days', 'otherNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-steroidal Anti-inflammatory', 'description': 'Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Steroid', 'description': 'Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraocular Pressure (IOP) Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Tears', 'description': 'Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days'}, {'id': 'OG001', 'title': 'Non-steroidal Anti-inflammatory', 'description': 'Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days'}, {'id': 'OG002', 'title': 'Steroid', 'description': 'Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '3.1', 'groupId': 'OG001'}, {'value': '-5.2', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 27 available at 6 weeks, 25 at 12 weeks); Non-steroidal anti-inflammatory (28 enrolled, 27 available at 6 and 12 weeks); Steroid (37 enrolled, 33 available at 6 weeks, 29 at 12 weeks).'}, {'type': 'SECONDARY', 'title': 'Intraocular Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Artificial Tears', 'description': 'Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days'}, {'id': 'OG001', 'title': 'Non-steroidal Anti-inflammatory', 'description': 'Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days'}, {'id': 'OG002', 'title': 'Steroid', 'description': 'Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 12', 'description': 'The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient data was incomplete due to inadequate measurement or follow up as follows: Artificial tears (31 enrolled, 31 available for data acquisition); Non-steroidal anti-inflammatory (29 enrolled, 26 available for data acquisition); Steroid (37 enrolled, 35 available for data acquisition).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Artificial Tears', 'description': 'Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days'}, {'id': 'FG001', 'title': 'Non-steroidal Anti-inflammatory', 'description': 'Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days'}, {'id': 'FG002', 'title': 'Steroid', 'description': 'Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Artificial Tears', 'description': 'Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days'}, {'id': 'BG001', 'title': 'Non-steroidal Anti-inflammatory', 'description': 'Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days'}, {'id': 'BG002', 'title': 'Steroid', 'description': 'Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '15', 'groupId': 'BG000'}, {'value': '60', 'spread': '11', 'groupId': 'BG001'}, {'value': '67', 'spread': '14', 'groupId': 'BG002'}, {'value': '65', 'spread': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2009-09-21', 'resultsFirstSubmitDate': '2016-12-28', 'studyFirstSubmitQcDate': '2009-09-21', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-28', 'studyFirstPostDateStruct': {'date': '2009-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP) Change', 'timeFrame': 'Baseline to Week 12', 'description': 'IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry.'}], 'secondaryOutcomes': [{'measure': 'Intraocular Inflammation', 'timeFrame': 'Up to week 12', 'description': 'The count of patients with inflammation defined as anterior chamber cells was measured in each study arm.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Trabeculoplasty', 'Selective laser trabeculoplasty', 'Intraocular pressure'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).', 'detailedDescription': 'SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of glaucoma\n* clinician has determined that SLT laser is indicated\n* IOP currently \\>18 and was ever \\>21 in the past (e.g. prior to treatment)\n\nExclusion Criteria:\n\n* prior history of uveitis\n* prior glaucoma surgery including glaucoma laser surgery\n* pregnant or 3 months post-partum'}, 'identificationModule': {'nctId': 'NCT00981435', 'acronym': 'SALT', 'briefTitle': 'Steroids After Laser Trabeculoplasty for Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT', 'orgStudyIdInfo': {'id': '20081142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Artificial Tears', 'description': 'Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.', 'interventionNames': ['Drug: Artificial Tears']}, {'type': 'EXPERIMENTAL', 'label': 'Non-steroidal anti-inflammatory', 'description': 'Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.', 'interventionNames': ['Drug: Ketorolac']}, {'type': 'EXPERIMENTAL', 'label': 'Steroid', 'description': 'Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty.', 'interventionNames': ['Drug: Prednisolone 1%']}], 'interventions': [{'name': 'Prednisolone 1%', 'type': 'DRUG', 'otherNames': ['Pred forte'], 'description': 'Prednisolone 1% to lasered eye 4 times/day for 4.5 days', 'armGroupLabels': ['Steroid']}, {'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['Voltaren'], 'description': 'Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days', 'armGroupLabels': ['Non-steroidal anti-inflammatory']}, {'name': 'Artificial Tears', 'type': 'DRUG', 'otherNames': ['saline tears'], 'description': 'Artificial saline tears to lasered eye 4 times/day for 4.5 days', 'armGroupLabels': ['Artificial Tears']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Jeffrey L Goldberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'IPD is anticipated to be shared upon publication of results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bascom Palmer Eye Institute', 'class': 'OTHER'}, {'name': 'University of Pittsburgh Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Ophthalmology', 'investigatorFullName': 'Jeffrey L Goldberg', 'investigatorAffiliation': 'Stanford University'}}}}