Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-26 @ 8:56 AM
Study NCT ID:
NCT04427995
Status:
TERMINATED
Last Update Posted:
2021-07-26
First Post:
2020-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standalone OMNI Surgical System for Open-angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'product expired and could not be resupplied', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2020-06-05', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower Intraocular Pressure and medication dependence', 'timeFrame': 'Postoperative week 1, month 1, month 3, annually', 'description': 'Change in IOP less than or equal to baseline with a medication reduction to 1 or less or an IOP change of 20% or less from baseline with medication'}], 'secondaryOutcomes': [{'measure': 'Examine the adverse event profile of the OMNI surgical system in patients with open angle glaucoma.', 'timeFrame': '1 month post operatively', 'description': 'Absence of the following complications:\n\n1\\. ) Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia, and/or; 2.) At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, endophthalmitis'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Open Angle Glaucoma']}, 'referencesModule': {'references': [{'pmid': '28237137', 'type': 'RESULT', 'citation': 'Conlon R, Saheb H, Ahmed II. Glaucoma treatment trends: a review. Can J Ophthalmol. 2017 Feb;52(1):114-124. doi: 10.1016/j.jcjo.2016.07.013. Epub 2016 Nov 17.'}, {'pmid': '28442693', 'type': 'RESULT', 'citation': "Francis BA, Akil H, Bert BB. Ab interno Schlemm's Canal Surgery. Dev Ophthalmol. 2017;59:127-146. doi: 10.1159/000458492. Epub 2017 Apr 25."}, {'pmid': '29613978', 'type': 'RESULT', 'citation': 'Grover DS, Smith O, Fellman RL, Godfrey DG, Gupta A, Montes de Oca I, Feuer WJ. Gonioscopy-assisted Transluminal Trabeculotomy: An Ab Interno Circumferential Trabeculotomy: 24 Months Follow-up. J Glaucoma. 2018 May;27(5):393-401. doi: 10.1097/IJG.0000000000000956.'}, {'pmid': '30425450', 'type': 'RESULT', 'citation': "Gallardo MJ, Supnet RA, Ahmed IIK. Viscodilation of Schlemm's canal for the reduction of IOP via an ab-interno approach. Clin Ophthalmol. 2018 Oct 23;12:2149-2155. doi: 10.2147/OPTH.S177597. eCollection 2018."}], 'seeAlsoLinks': [{'url': 'https://omnisurgical.com/.', 'label': 'Related Info'}, {'url': 'https://www.accessdata.fda.gov/cdrh_docs/pdf17/K173332.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP). The OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising MIGS procedure. It combines two procedures known as trabeculotomy and viscodilation of Schlemm's canal in one hand held device without the need for additional incisions or extra instrumentation. The device recently received FDA approval in the United States for certain indications in ophthalmic surgery. To date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and IOP.", 'detailedDescription': "The emergence of minimally invasive glaucoma surgeries (MIGS) has seen a variety of potential innovative surgical alternatives to help better control intraocular pressure (IOP).1 The OMNI™ Surgical System (Sight Sciences, Menlo Park, CA, USA) is a promising procedure which targets the conventional outflow pathway.2 This device treats the trabecular meshwork, Schlemm's canal and the distal collector channels, all conventional pathway points of aqueous outflow resistance. Its designed microcatheter allows for cannulation of Schlemm's canal, dilation using the controlled delivery of viscoelastic as well as a trabeculotomy by stripping the trabecular meshwork will retracting the catheter.3 Goniotomy-assisted transluminal trabeculotomy (GATT) has shown promising results in using an ab interno approach to cleave the trabecular meshwork.4 Alternatively, viscodilation alone has also shown an IOP lowering effect. 5 The OMNI Surgical System combines both procedures in one hand held device without the need for additional incisions or extra instrumentation. The device recently received FDA approval in the United States for delivery of small amounts of viscoelastic fluid during ophthalmic surgery and to cut trabecular meshwork tissue during trabeculotomy procedures.6 To date, no study has examined the effect of standalone viscodilation and trabeculotomy on glaucoma drop burden and IOP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma with IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy. Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.\n* Exclusions: Other forms of glaucoma, prior incisional glaucoma surgery, prior corneal graft (PKP, DALK, DSAEK, DMEK), Shafer angle grading \\<2 in 2 or more quadrants.', 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma.\n* An IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy.\n* Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.\n\nExclusion Criteria:\n\n* Other forms of glaucoma,\n* prior incisional glaucoma surgery,\n* prior corneal graft (PKP, DALK, DSAEK, DMEK),\n* Shafer angle grading \\<2 in 2 or more quadrants.'}, 'identificationModule': {'nctId': 'NCT04427995', 'acronym': 'OMNIgl', 'briefTitle': 'Standalone OMNI Surgical System for Open-angle Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Prism Eye Institute'}, 'officialTitle': 'Standalone OMNI Surgical System for Open-angle Glaucoma', 'orgStudyIdInfo': {'id': '948'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oen Angle Glaucoma', 'description': '• Patients aged 30-95 with primary or pigmentary / pseudoexfolliative / juvenile / normal pressure open angle glaucoma or combined mechanism glaucoma with IOP of 10-40 mmHg on maximum tolerated medical therapy who are either progressing, above IOP target, or poorly adherent or tolerant to medical therapy. Phakic or pseudophakic eyes and previous laser trabeculoplasty will be included.', 'interventionNames': ['Device: OMNI surgical system']}], 'interventions': [{'name': 'OMNI surgical system', 'type': 'DEVICE', 'otherNames': ['OMNI surgical systems'], 'description': 'GATT + viscodilation', 'armGroupLabels': ['Oen Angle Glaucoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L6H 0J8', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Prism Eye Institute', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}], 'overallOfficials': [{'name': 'Iqbal Ahmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prism Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iqbal Ahmed', 'class': 'OTHER'}, 'collaborators': [{'name': 'OMNI Medical Services, LLC', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Iqbal Ahmed', 'investigatorAffiliation': 'Prism Eye Institute'}}}}