Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT00801658
Status:
COMPLETED
Last Update Posted:
2008-12-04
First Post:
2008-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2009-07'}, 'lastUpdateSubmitDate': '2008-12-03', 'studyFirstSubmitDate': '2008-12-02', 'studyFirstSubmitQcDate': '2008-12-02', 'lastUpdatePostDateStruct': {'date': '2008-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP lowering effect of SLT in a special patient group', 'timeFrame': '1 day, 1 , 3, 6 , 12 months postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma', 'SLT', 'Laser treatment', 'IOP', 'glaucoma treated with eye drops but IOP not controlled'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Examination and follow-up of efficacy and safety of SLT in patients with unsufficient IOP control despite maximum tolerated topical therapy. In addition, it will be examined whether medical treatment can be reduced after the SLT procedure and whether filtering surgery - as the only remaining option - may be postponed.', 'detailedDescription': 'SLT (Selective Laser Trabeculoplasty) uses the Nd:YAG-Lasers (wavelength 532nm, Q-switched, frequency-doubled). Thanks to the low laser energy used and the short duration of treatment, only pigmented cells of the trabecular meshwork are targeted and selectively treated. Neighboring, non-pigmented cells and tissue are spared collateral and thermic damage, the architecture of the trabecular meshwork remains intact. The SLT procedure uses less than 1% of the energy of the ALT procedure with an extremely low pulsation duration.\n\nSeveral studies confirm the effective IOD reduction of SLT and rate the procedure as an relatively safe and effective therapy for glaucoma. Also repeated use of the SLT procedure is considered as meaningful. Meanwhile the SLT procedure is used as primary and supplementary treatment of glaucoma and study confirmed that the SLT procedure was just as effective as administration of Latanoprost in reducing IOD in newly-diagnosed glaucoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria: Patients with\n\n* primary open angle glaucoma (including normal tension glaucoma)\n* pseudoexfoliation glaucoma\n* pigment dispersion glaucoma\n\nExclusion criteria: previous intraocular surgery closed angle glaucoma pediatric glaucoma inflammatory or uveitic glaucoma unclear view of the trabecular meshwork'}, 'identificationModule': {'nctId': 'NCT00801658', 'briefTitle': 'Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'orgStudyIdInfo': {'id': 'FunkSLT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'selective Laser Trabeculoplasty (SLT)', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'country': 'Switzerland', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': '01 Studienregister MasterAdmins', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UniversitaetsSpital Zuerich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ellex Medical Pty, 82 Gilbert Str., Adelaide, SA 5000', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Dr. Jens Funk', 'oldOrganization': 'University hospital zurich, eye clinic'}}}}