Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-01 @ 4:18 AM
Study NCT ID:
NCT01798732
Status:
COMPLETED
Last Update Posted:
2014-11-17
First Post:
2012-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PIO Laser Sclerectomy IOP SLT Sclerectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'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': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-14', 'studyFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2014-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP change over 24 hours after selective trabeculoplasty SLT according to chronobiological data (decrease of IOP; type of 24h-IOP rhythm and 24h-PPm rhythm: MESOR, acrophase, bathyphase, amplitude and modeling)', 'timeFrame': 'Baseline and 6 months'}], 'secondaryOutcomes': [{'measure': 'Changes in the rate of ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after SLT.', 'timeFrame': 'Baseline and 6 months', 'description': '* To find predictive factors 1 month before efficacy of the treatment (after 6 month). Efficacy is defined by a mean IOP decrease, at least 30%, with a smoothed pressure-peaks (decrease at least 40% of pressure changes)\n* To characterize changes of ocular blood flow parameters (optic nerve head; Volume, Velocity and Flow): 20% at least of increase.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Primary Open-Angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '22025580', 'type': 'BACKGROUND', 'citation': 'Khayi H, Pepin JL, Geiser MH, Tonini M, Tamisier R, Renard E, Baguet JP, Levy P, Romanet JP, Chiquet C. Choroidal blood flow regulation after posture change or isometric exercise in men with obstructive sleep apnea syndrome. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9489-96. doi: 10.1167/iovs.11-7936.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to characterize the changes in IOP over 24 hours after selective trabeculoplasty SLT (before and 1 and 6 months after treatment, decreased IOP, type of rhythm, mesor, acrophase, amplitude). The secondary objective is to evaluate changes in ocular perfusion pressure (arterial pressure - IOP) and ocular blood flow in the optic nerve head after selective laser trabeculoplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary Open-Angle Glaucoma\n* IOP more than 21 mmHg\n* Progression under maximal medical therapy\n* aged more than 18 years\n\nExclusion Criteria:\n\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT01798732', 'acronym': 'PIO laser SPNP', 'briefTitle': 'PIO Laser Sclerectomy IOP SLT Sclerectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Effect of Selective Laser Trabeculoplasty on the Intraocular Pressure Nycthemeral Rhythm.', 'orgStudyIdInfo': {'id': '1012'}, 'secondaryIdInfos': [{'id': '2010-A00932-37', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selective laser trabeculoplasty (Tango Laser, Ellex)', 'description': 'Patients treated with selective laser trabeculoplasty (Tango Laser, Ellex, Minneapolis, USA)', 'interventionNames': ['Procedure: Selective Laser Trabeculoplasty (Tango Laser, Ellex)']}], 'interventions': [{'name': 'Selective Laser Trabeculoplasty (Tango Laser, Ellex)', 'type': 'PROCEDURE', 'description': 'One session of selective laser trabeculoplasty with the following parameters (inferior half-circumference, 50 shots, 0.8 to 1.3 mJ)', 'armGroupLabels': ['Selective laser trabeculoplasty (Tango Laser, Ellex)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Grenoble', 'country': 'France', 'facility': 'University Hospital of Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Jean-Paul ROMANET, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}