Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT01338467
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2011-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-15', 'studyFirstSubmitDate': '2011-04-15', 'studyFirstSubmitQcDate': '2011-04-18', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary efficacy measure :', 'timeFrame': '6 months', 'description': 'IOP change (mmHg and Percent) from baseline to 6 months post-HIFU treatment'}], 'secondaryOutcomes': [{'measure': 'Safety measures', 'timeFrame': '6 months', 'description': 'The incidence of device and procedure-related complications during the follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Glaucoma', 'Refractory glaucoma', 'Cyclocoagulation', 'High Intensity Focused Ultrasound'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '25604688', 'type': 'RESULT', 'citation': 'Denis P, Aptel F, Rouland JF, Nordmann JP, Lachkar Y, Renard JP, Sellem E, Baudouin C, Bron A. Cyclocoagulation of the ciliary bodies by high-intensity focused ultrasound: a 12-month multicenter study. Invest Ophthalmol Vis Sci. 2015 Jan 20;56(2):1089-96. doi: 10.1167/iovs.14-14973.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effectiveness and the safety of the EYEOP treatment using High Intensity Focused Ultrasound in refractory glaucoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary open angle glaucoma included pseudo-exfoliative glaucoma and pigmentary glaucoma in the study eye with maximally tolerated medical treatment\n* Ocular hypertension defined as an intraocular pressure (IOP) \\> 21 mm Hg\n* Subject has failed a conventional intraocular glaucoma filtering surgery\n* Patient must be aged 18 years or more\n* No previous intraocular glaucoma surgery or laser treatment in the study eye during the 3 months before HIFU treatment\n* No previous cyclophotocoagulation procedure in the study eye\n* Patient able and willing to provide informed consent and to complete post-operative follow-up requirements.\n\nExclusion Criteria:\n\n* History of previous glaucoma surgery with implantation of glaucoma drainage device in the study eye\n* History of ocular or retrobulbar tumor\n* Retinal detachment, choroidal hemorrhage or detachment\n* Ocular infectious disease within 14 days before HIFU treatment'}, 'identificationModule': {'nctId': 'NCT01338467', 'briefTitle': 'Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound With the EYEOP Medical Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'EyeTechCare'}, 'officialTitle': 'Glaucoma Treatment by Circular Cyclocoagulation Using High Intensity Focused Ultrasound (HIFU). A Prospective, Multicenter, Open-label, Safety and Efficacy Study of the Treatment With the EYEOP Medical Device in Patients With Refractory Glaucoma', 'orgStudyIdInfo': {'id': 'EYEMUST'}, 'secondaryIdInfos': [{'id': '2011-A00196-35', 'type': 'OTHER', 'domain': 'French Health Product Safety Agency (AFSSAPS)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EYEOP Treatment', 'description': 'Open label, all subject treated by the EYEOP device', 'interventionNames': ['Device: EYEOP device']}], 'interventions': [{'name': 'EYEOP device', 'type': 'DEVICE', 'description': 'Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device', 'armGroupLabels': ['EYEOP Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'University Hospital - Cl Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69006', 'city': 'Lyon', 'country': 'France', 'facility': 'Clinique du Parc - Private Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'XV-XX National Ophthalmologic Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'XV-XX Ophthalmologic Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Saint-Joseph Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75235', 'city': 'Paris', 'country': 'France', 'facility': 'Val de Grace Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Philippe DENIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Croix Rousse Hospital - Lyon - France'}, {'name': 'Laurent FARCY', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EyeTechCare'}, {'name': 'Florent APTEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital - Grenoble - France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EyeTechCare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}