Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-29 @ 7:06 PM
Study NCT ID:
NCT05062668
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2021-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of iStent Inject and Inject W in the Management of Primary Open-angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'variation of IOP (in mmHg) between both groups', 'timeFrame': '1 year', 'description': 'variation of IOP (in mmHg) between the istent and cataract operation group versus the cataract operation only group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['POAG', 'iStent inject', 'MIGS'], 'conditions': ['POAG', 'MIGS']}, 'descriptionModule': {'briefSummary': 'Primary open-angle glaucoma (POAG) is a chronic eye disease in which the only validated treatment is to lower intraocular pressure (IOP). It is the 2nd leading cause of blindness worldwide. The iStent® inject and inject W is an implantable device that is part of a new entity of so-called minimally invasive glaucoma surgery whose goal is to lower IOP with minimal tissue disruption in order to avoid the complications of conventional glaucoma surgery. This surgery is used in conjunction with cataract surgery in France. The primary objective is to study the 1-year efficacy and safety of combined cataract and iStent inject and inject W in the management of POAG in an observational, retrospective, controlled study of a cohort of POAG patients undergoing cataract surgery only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'There are two groups, the first group is the iStent group. The investigators took all the POAG patients operated at the CHU of Amiens or the CH of Saint-Quentin of a combined cataract and iStent inject or inject W surgery from January 2018 to September 2020. The second group is the control group of POAG patients operated only on cataract during the same period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient who have undergone combined phacoemulsification surgery and insertion of at least one iStent® for chronic open-angle glaucoma in the ophthalmology department of the Amiens University Hospital or the Saint-Quentin University Hospital (iStent® group).\n* patient who have undergone simple phacoemulsification surgery in a patient with chronic open-angle glaucoma in the ophthalmology department of the Amiens University Hospital (control group).\n* patient with Chronic open-angle glaucoma confirmed by gonioscopic examination, visual field, optical coherence tomography of the optic nerve, fundus examination, pachymetry and intraocular air pressure and/or applanation.\n\nExclusion Criteria:\n\n* acute angle closure glaucoma,\n* chronic angle closure glaucoma,\n* uveitic glaucoma,\n* traumatic glaucoma,\n* exfoliative glaucoma.\n* Previous filtering surgery on the operated eye.\n* Intraoperative complication.'}, 'identificationModule': {'nctId': 'NCT05062668', 'acronym': 'EII', 'briefTitle': 'Efficacy and Safety of iStent Inject and Inject W in the Management of Primary Open-angle Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Efficacy and Safety of iStent Inject and Inject W in the Management of Primary Open-angle Glaucoma', 'orgStudyIdInfo': {'id': 'PI2021_843_0191'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'iStent', 'description': 'POAG patient operated at the CHU of Amiens or the CH of Saint-Quentin of a combined cataract and iStent inject or inject W surgery from January 2018 to September 2020.', 'interventionNames': ['Procedure: cataract operation and istent']}, {'label': 'cataract only', 'description': 'POAG patients operated only on cataract from January 2018 to September 2020.', 'interventionNames': ['Procedure: cataract operation only']}], 'interventions': [{'name': 'cataract operation and istent', 'type': 'PROCEDURE', 'description': 'a cataract operation and the placement of one or two iStent inject or inject W at the same time', 'armGroupLabels': ['iStent']}, {'name': 'cataract operation only', 'type': 'PROCEDURE', 'description': 'Patients have a classic postoperative treatment after cataract.', 'armGroupLabels': ['cataract only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin Jany, MD', 'role': 'CONTACT', 'email': 'jany.benjamin@chu-amiens.fr', 'phone': '03 22 08 92 19'}], 'facility': 'CHU Amiens Nord', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Benjamin Jany, MD', 'role': 'CONTACT', 'email': 'jany.benjamin@chu-amiens.fr', 'phone': '03 22 08 92 19'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Central Hospital Saint Quentin', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}