Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT00145535
Status:
COMPLETED
Last Update Posted:
2010-01-29
First Post:
2005-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SOLX Titanium Sapphire Laser for Trabeculoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-28', 'studyFirstSubmitDate': '2005-09-01', 'studyFirstSubmitQcDate': '2005-09-01', 'lastUpdatePostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular Pressure (IOP)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Adverse event frequency', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Glaucoma, open angle', 'Intraocular Pressure', 'Trabeculoplasty', 'laser', 'laser, surgery'], 'conditions': ['Glaucoma', 'Glaucoma, Open Angle']}, 'descriptionModule': {'briefSummary': 'Use of the Titanium Sapphire laser for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty.', 'detailedDescription': 'This is a multi-center, outpatient study assessing equivalence of the Titanium Sapphire laser (TiSaLT) to the Argon laser (ALT) in the ability to reduce IOP in patients having primary open angle glaucoma in eyes with poorly controlled IOP on maximally tolerated medications and/or prior failed glaucoma surgery. Approximately 120 patients are to be enrolled in the study, with approximately equal numbers of patients enrolled at each of the investigational sites. The investigational sites are to accrue patients with poorly controlled open-angle glaucoma on maximal tolerated medical therapy and/or patients with previously failed laser trabeculoplasty. One half of the eyes will be randomized to treatment with the Argon laser (ALT) as the concurrent control group and the other half will be treated with Titanium Sapphire (TiSaLT) laser.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Clinical Diagnosis of Open Angle Glaucoma\n\n* Patient is aged 18 years or older, with 2 sighted eyes.\n* Eye to be treated have average IOP greater or equal to 22 mmHg, measured at 2 pretreatment visits.\n* Eye to be treated either exhibits:\n* poorly controlled open angle glaucoma and on maximal tolerated medical therapy\n* OR poorly controlled open angle glaucoma and failed previous laser trabeculoplasty (180° available to treat if previous ALT; can treat over previous SLT)\n\nExclusion Criteria:\n\nPatients are not eligible for enrollment if any of the following exclusion criteria are met:\n\n* Eye to be treated has any of the following:\n\n 1. evidence of glaucoma other than open-angle glaucoma;\n 2. severe paracentral or generalized field defect;\n 3. any ocular condition that precluded adequate visualization and treatment of the trabecular meshwork.\n 4. prior glaucoma surgery other than laser trabeculoplasty or peripheral iridotomy.\n* Patient has mental impairment such that he/she could not understand the protocol or is not in a position to provide written informed consent.\n* Patient is pregnant.\n* Patient might require other ocular surgery within the 6-month follow-up period.\n* Patient has a medical history that suggested the potential for complications from TiSaLT.\n* Having concurrent treatment with systemic steroids.'}, 'identificationModule': {'nctId': 'NCT00145535', 'briefTitle': 'SOLX Titanium Sapphire Laser for Trabeculoplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'SOLX, Inc.'}, 'officialTitle': 'SOLX Titanium Sapphire Laser for Trabeculoplasty', 'orgStudyIdInfo': {'id': 'SLX41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Titanium sapphire laser treatment', 'interventionNames': ['Device: SOLX Titanium Sapphire Laser (TiSaLT)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Argon laser treatment', 'interventionNames': ['Device: Argon Laser Trabeculoplasty (ALT)']}], 'interventions': [{'name': 'SOLX Titanium Sapphire Laser (TiSaLT)', 'type': 'DEVICE', 'description': 'Spot laser treatment, \\~50 spots over 180°', 'armGroupLabels': ['1']}, {'name': 'Argon Laser Trabeculoplasty (ALT)', 'type': 'DEVICE', 'description': 'Spot laser treatment, \\~50 spots over 180°', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'North Bay Eye Associates', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'International Eye Care', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Glaucoma Associates of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texan Eye Care', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77002', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Mann Eye Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'L5L 1W8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Credit Valley EyeCare', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'H1V 1G5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut du Glaucome de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Jan S Peterson, MS, RAC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Emmes Company, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SOLX, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Doug Adams', 'oldOrganization': 'SOLX, Inc.'}}}}