Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-04 @ 8:08 PM
Study NCT ID:
NCT07480603
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-18
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study on a New Self Adjustable Glaucoma Drainage Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '3 months', 'description': 'Type and rate of complications post-surgery'}, {'measure': 'IOP reduction', 'timeFrame': 'Baseline versus every visit, up to 1 year', 'description': 'IOP reduction by \\>20%'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glaucoma, drainage device, filtering surgery'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'A new self-adjustable glaucoma drainage device has been developed. And to test its efficacy and its safety, a pilot study is designed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 to 90 years.\n\nDiagnosis of primary open-angle glaucoma meeting the following criteria:\n\n* Intraocular pressure (IOP) not controlled by at least one (1) or more classes of topical IOP-lowering medications, and\n* Eye without visual acuity.\n\nPatients must be able to understand the study requirements and provide written informed consent.\n\nPatients must be willing to follow study instructions, agree to comply with all study procedures, and be able to attend all scheduled follow-up visits for at least 6 months after surgery.\n\nExclusion Criteria:\n\n* Previous filtering surgery, secondary glaucoma, severe systemic disease, pregnancy, breastfeeding, or inability to understand or provide informed consent.\n\nPregnant or breastfeeding women, or women of childbearing potential who are not willing to use a medically acceptable method of contraception from the screening visit until the 12-month follow-up visit.\n\nKnown or suspected allergy or hypersensitivity to any component of the device (e.g., silicone).\n\nCurrent participation, or participation within the last 30 days (from the screening visit), in another investigational drug or interventional device clinical trial.'}, 'identificationModule': {'nctId': 'NCT07480603', 'acronym': 'eV-SEN', 'briefTitle': 'Pilot Study on a New Self Adjustable Glaucoma Drainage Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rheon Medical SA'}, 'officialTitle': 'Pilot Study eyeValve', 'orgStudyIdInfo': {'id': 'eV-7007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eyeValve', 'description': 'Patient treated with the device', 'interventionNames': ['Device: eyeValve']}], 'interventions': [{'name': 'eyeValve', 'type': 'DEVICE', 'description': 'Implantation of a self adjustable glaucoma drainage device', 'armGroupLabels': ['eyeValve']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sali', 'country': 'Senegal', 'facility': 'SwissVisio', 'geoPoint': {'lat': 14.44111, 'lon': -17.01944}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rheon Medical SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}