Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT04503356
Status:
UNKNOWN
Last Update Posted:
2020-08-11
First Post:
2020-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OMNI in Open-angle Glaucoma Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D002386', 'term': 'Cataract'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To prospectively assess the clinical effect of ab-interno transluminal viscodilation and trabeculotomy performed using the OMNI Surgical System as a standalone procedure or in combination with cataract extraction on intraocular pressure (IOP) and the use of ocular hypotensive medications in patients with open-angle glaucoma (OAG).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-07', 'studyFirstSubmitDate': '2020-08-04', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of eyes with a 20% reduction from baseline in IOP at 12 months on the same number, or fewer, ocular hypotensive medications as at the pre-operative baseline', 'timeFrame': '1 year'}, {'measure': 'Number of Participants wih Postoperative complications', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glaucoma', 'open-angle glaucoma', 'cataract', 'glaucoma surgery', 'ophthalmology', 'OMNI'], 'conditions': ['Open Angle Glaucoma', 'Cataract', 'Eye Diseases', 'Glaucoma']}, 'descriptionModule': {'briefSummary': 'This single-center, prospective study will assess safety and effectiveness of 360 degree viscodilation followed by up to 360 degree trabeculotomy used in patients with early or moderate open-angle glaucoma in a real-world setting either as a standalone procedure in pseudophakic patients (or phakic) or combined with phacoemulsification cataract procedures.\n\nMedication usage, IOP and secondary surgical procedures necessary for IOP control will be analyzed during the follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with open-angle glaucoma including pigmentary and pseudoexfoliative glaucoma\n* 0-3 topical ocular hypotensive medications at preoperative baseline. Fixed combinations counted as number of components\n* Open angles (Shaffer grade ≥3)\n* early or moderate glaucoma (based on visual field)\n* Subjects with a combined procedure should have had uncomplicated cataract surgery (i.e. intact and centered capsulorrhexis, intact posterior capsular bag, no evidence of zonular dehiscence or rupture, well centered IOL)\n\nExclusion Criteria:\n\n* Any of the following prior treatments for glaucoma:\n\n * Suprachoroidal stent\n * Laser trabeculoplasty ≤6 months prior to OMNI procedure\n * Trabecular bypass implanted ≤6 months prior to OMNI procedure\n * Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve\n * Prior canaloplasty, goniotomy, or trabeculotomy\n* Forms of glaucoma other than OAG including: acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma\n* Under treatment with oral carbonic anhydrase inhibitor at the preoperative visit\n* Clinically significant ocular pathology, other than age-related cataract and glaucoma. (e.g. wet AMD, uveitis, corneal edema, proliferative diabetic retinopathy, optic neuritis in medical history)'}, 'identificationModule': {'nctId': 'NCT04503356', 'briefTitle': 'OMNI in Open-angle Glaucoma Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Centre of Postgraduate Medical Education'}, 'officialTitle': 'Evaluation of the Effectiveness of the New Surgical Method OMNI in the Treatment of Adult Patients With Open-angle Glaucoma', 'orgStudyIdInfo': {'id': '44/PB/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OMNI as a standalone procedure', 'interventionNames': ['Procedure: OMNI as a standalone procedure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OMNI combined with cataract surgery', 'interventionNames': ['Procedure: OMNI combined with cataract surgery']}], 'interventions': [{'name': 'OMNI as a standalone procedure', 'type': 'PROCEDURE', 'description': "It uses a single, self-sealing clear corneal incision with ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System as a standalone procedure.", 'armGroupLabels': ['OMNI as a standalone procedure']}, {'name': 'OMNI combined with cataract surgery', 'type': 'PROCEDURE', 'description': "Phacoemulsification with intraocular lens implantation is performed. Then, ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System.", 'armGroupLabels': ['OMNI combined with cataract surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00-401', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Orlowski Hospital, Centre of Postgraduate Medical Education', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Iwona Grabska-Liberek, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmology Clinic Centre of Postgraduate Medical Education, Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre of Postgraduate Medical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Iwona Grabska- Liberek', 'investigatorAffiliation': 'Centre of Postgraduate Medical Education'}}}}