Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT01495312
Status:
WITHDRAWN
Last Update Posted:
2019-05-30
First Post:
2011-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to staff departures unable to execute this study so requested closure. There were no study procedures performed \\& no participants enrolled.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2013-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-28', 'studyFirstSubmitDate': '2011-12-12', 'studyFirstSubmitQcDate': '2011-12-19', 'lastUpdatePostDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP', 'timeFrame': '2 months after SLT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IOP fluctuations', 'during two 24-hour periods'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the relationship between Intraocular Pressure (IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens (SENSIMED Triggerfish®), during two 24-hour periods after selective laser trabeculoplasty (SLT) for routine treatment of glaucoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must correspond to all other inclusion criteria in order to be eligible for the investigation.\n\n * Subject is able to comply with the study procedures\n * 18-80 years old\n * Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of \\> 22 mmHg at the screening visit and under ocular hypotensive treatment.\n * Subject has consented to be in the trial\n * Visual acuity of 20/200 or better\n * Ability to understand the character and individual consequences of the study\n * For women of childbearing potential, adequate contraception\n\nExclusion Criteria:\n\n* Subjects presenting with any of the following criteria will not be included in the trial:\n\n * Subjects with contraindications for wearing contact lenses\n * Severe dry eye syndrome\n * Keratoconus or other corneal abnormality\n * Conjunctival or intraocular inflammation\n * Eye surgery prior to and throughout the study.\n * Full frame metal glasses during SENSIMED Triggerfish® monitoring\n * Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)\n * Pregnancy and lactation\n * Simultaneous participation in other clinical studies'}, 'identificationModule': {'nctId': 'NCT01495312', 'briefTitle': '24-hr Intraocular Pressure (IOP) Patterns of Glaucoma Patients After Selective Laser Trabeculoplasty (SLT)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'orgStudyIdInfo': {'id': 'TFSLT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SLT', 'interventionNames': ['Device: SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish']}], 'interventions': [{'name': 'SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish', 'type': 'DEVICE', 'description': 'SLT (single session; 180 to 360 degrees of angle will be treated)', 'armGroupLabels': ['SLT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate', 'investigatorFullName': 'Eunice Williams-Steppe', 'investigatorAffiliation': 'University of California, San Diego'}}}}