Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT02789293
Status:
COMPLETED
Last Update Posted:
2021-08-19
First Post:
2016-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients
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': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2016-06-01', 'lastUpdatePostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy endpoint : Reduction of intraocular pressure', 'timeFrame': '24 months', 'description': 'Reduction of intraocular pressure at 24 months relative to the preoperative value assessed at each follow-up visits with the final measurement of success at 24 months'}], 'secondaryOutcomes': [{'measure': 'Safety : rate of per and post-operative complications/adverse effects', 'timeFrame': '24 months', 'description': 'rate of per-operative device and /or procedure related adverse events and post-operative complications at each follow-up visits'}, {'measure': 'Efficacy endpoint : Mean IOP (mmHg)', 'timeFrame': '24 months', 'description': 'Evolution of the Mean IOP (mmHg) at each visit during the follow-up period (Baseline to 24 months)'}, {'measure': 'Efficacy Endpoint : Mean IOP variation (%)', 'timeFrame': '24 months', 'description': 'Mean IOP variation (%) at each visit during the follow-up period'}, {'measure': 'Mean Number of ocular hypotensive medications', 'timeFrame': '24 months', 'description': 'Mean number of ocular hypotensive medication at each visit during the followup period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Ultrasound', 'Ciliary body'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF))\n* Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction)\n* Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP ≥ 21 mm Hg and \\<30 mmHg\n* No previous intraocular surgery or laser treatment during the 90 days before HIFU Day\n* Age \\> 18 years and \\< 90 years\n* Patient able and willing to complete postoperative follow-up requirements\n\nExclusion Criteria:\n\n* Patient who has been diagnosed for normal tension glaucoma\n* Ocular or retrobulbar tumor\n* Ocular infection within 14 days prior to the HIFU procedure\n* Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinically significant macular edema…)'}, 'identificationModule': {'nctId': 'NCT02789293', 'briefTitle': 'Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'EyeTechCare'}, 'officialTitle': 'Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients', 'orgStudyIdInfo': {'id': 'ETC-EU-BN02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Focused Ultrasound treatment', 'description': 'Ultrasound ciliary pasty (UCP) using focused ultrasound', 'interventionNames': ['Device: EyeOP1 device']}], 'interventions': [{'name': 'EyeOP1 device', 'type': 'DEVICE', 'description': 'Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound', 'armGroupLabels': ['Focused Ultrasound treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven - University Hospital', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'city': 'Pisa', 'country': 'Italy', 'facility': 'Cisanello Hospital', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '1649-028', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Santa Maria Hospital - Faculty of Medicine of Lisbon', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EyeTechCare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}