Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-28 @ 5:19 AM
Study NCT ID:
NCT06615661
Status:
RECRUITING
Last Update Posted:
2025-03-20
First Post:
2024-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2024-09-24', 'studyFirstSubmitQcDate': '2024-09-24', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline.', 'timeFrame': '12 month postoperative', 'description': 'Intraocular pressure (IOP) is at least 20% lower than before surgery without additional ocular hypotensive medications or IOP-lowering surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Ocular Hypertension', 'Eye Diseases', 'Glaucoma', 'Goniotomy'], 'conditions': ['Primary Open Angle Glaucoma (POAG)']}, 'descriptionModule': {'briefSummary': 'This study enrolls adults with primary open angle glaucoma (POAG) who underwent goniotomy intraocular pressure (IOP)-lowering surgery with the C-Rex Instrument. Patients are consented prior to surgery and followed for 12 months postoperatively. Data regarding IOP, use of glaucoma medications, and any device-related complications are collected during the study time period.', 'detailedDescription': 'This a multicenter, observational real-world evidence study of eligible adults with primary open angle glaucoma (POAG) in whom ab-interno goniotomy surgery with the C-Rex Instrument was performed.\n\nData is collected from the preoperative visit(s) that directly preceded the surgery, the surgical procedure, and post-surgical visits through 12 months postoperatively.\n\nSpecific data collected includes C-Rex Instrument goniotomy surgical details, preoperative and postoperative IOP and use of ocular hypotensive medications, and device-related safety events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible participants who underwent IOP-lowering surgical procedures using the C-Rex Instrument to perform ab-interno goniotomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary open angle glaucoma\n* Goniotomy surgery performed using the C-Rex Instrument\n\nExclusion Criteria:\n\n* History of intraocular surgery within 8 weeks prior to C-Rex surgery\n* Preoperative IOP higher than 33 mmHg\n* Presence of a glaucoma type other than POAG\n* Presence of clinically significant intraocular pathology other than cataract or glaucoma'}, 'identificationModule': {'nctId': 'NCT06615661', 'acronym': 'CIRCLE', 'briefTitle': 'A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iantrek, Inc.'}, 'officialTitle': 'An Observational Real-World Evidence Study of Ab-Interno Goniotomy Performed Using the C-Rex Instrument in Patients With Primary Open Angle Glaucoma', 'orgStudyIdInfo': {'id': 'ITR-GON-041'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'C-Rex surgery - combination', 'description': 'C-Rex surgery combined with cataract extraction/intraocular lens (IOL) implantation', 'interventionNames': ['Device: C-Rex Instrument']}, {'label': 'C-Rex surgery - standalone', 'description': 'C-Rex surgery as a standalone intervention', 'interventionNames': ['Device: C-Rex Instrument']}], 'interventions': [{'name': 'C-Rex Instrument', 'type': 'DEVICE', 'description': 'The C-Rex Instrument is a manual ophthalmic surgical instrument used for ab interno goniotomy and inner wall trabeculotomy.', 'armGroupLabels': ['C-Rex surgery - combination', 'C-Rex surgery - standalone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Study Coordinator', 'role': 'CONTACT', 'email': 'swegemer@gmail.com', 'phone': '404-257-0814'}], 'facility': 'Omni Eye Services', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '38555', 'city': 'Crossville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 04 Study Coordinator', 'role': 'CONTACT', 'email': 'meganf@ecotn.com', 'phone': '931-265-5879'}], 'facility': 'CIRCLE Site 04', 'geoPoint': {'lat': 35.94896, 'lon': -85.0269}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iantrek, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}