Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-25 @ 4:06 PM
Study NCT ID:
NCT03494257
Status:
COMPLETED
Last Update Posted:
2018-04-11
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Patients will be unaware of their groupe assignment. The investigator who will measure the IOP will also be masked to group assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomized double-masked comparative study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-09', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-09', 'lastUpdatePostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP at 6 hours after surgery', 'timeFrame': '6 hours postoperatively', 'description': 'IOP will be measured by the same Goldman applanation tonometer used preoperatively'}], 'secondaryOutcomes': [{'measure': 'IOP at 12 hours after surgery', 'timeFrame': '12 hours postoperatively', 'description': 'IOP will be measured by the same Goldman applanation tonometer used preoperatively'}, {'measure': 'IOP at 24 hours after surgery', 'timeFrame': '12 hours postoperatively', 'description': 'IOP will be measured by the same Goldman applanation tonometer used preoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['phacoemulsification', 'intraocular pressure', 'cataract', 'brinzolamide', 'brimonidinde', 'fixed combination'], 'conditions': ['Cataract', 'Intraocular Pressure']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of fixed brinzolamide-brimonidine combination on intaocular pressure after uncomplicated phacoemulsification surgery.\n\nPatients scheduled for phacoemulsification will be randomly assigned to 1 of 2 groups.\n\nThe treatment group will receive 1 drop of brimonidine-brinzolamide fixed combination immediately after surgery, and the control group will receive no treatment. The IOP will be measured preoperatively and at 6, 12, and 24 hours postoperatively.', 'detailedDescription': 'Phacoemulsification with the use of an ophthalmic viscosurgical device (OVD) and implantation of a foldable intraocular lens (IOL) is the preferred technique for cataract surgery today.\n\nOVDs in spite of their advantages in phacoemulsification surgery, have been correlated with intraocular pressure (IOP) increase within the first 24 hours postoperatively. This constitutes a frequent short-term complication of cataract surgery and can lead to corneal edema and pain. This IOP rise may also increase the risk of retinal artery occlusion, ischemic optic neuropathy, and deterioration of preexisting glaucomatous nerve damage.\n\nDuoVisc, an OVD that consists of Viscoat (chondroitin sulfate 4.0%-sodium hyaluronate 3.0%) in combination with Provisc (sodium hyaluronate 1.0%) is the most frequently used OVD during cataract surgery.\n\nTo prevent IOP spikes postoperatively, various antiglaucoma agents have been used. Brinzolamide is a carbonic anhydrase inhibitor that acts upon the ciliary processes and reduces aqueous humor secretion.Brimonidine is a highly selective a2-adrenergic agonist that increases uveoscleral outflow and reduces aqueous humor production.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients scheduled to undergo cataract surgery by phacoemulsification.\n\nExclusion Criteria:\n\n* previous ocular surgery\n* ocular hypertension\n* pseudoexfoliation syndrome\n* pigment dispersion syndrome\n* glaucoma\n* history of severe cardiovascular disease, cerebral or coronary insufficiency, depression, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans\n* hypersensitivity to sulfonamides or brimonidine"}, 'identificationModule': {'nctId': 'NCT03494257', 'briefTitle': 'Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Patras'}, 'officialTitle': 'Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification', 'orgStudyIdInfo': {'id': '58/15.02.2018/5104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Brinzolamide-Brimonidine fixed combination', 'description': '1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery', 'interventionNames': ['Drug: Brinzolamide-Brimonidine fixed combination']}, {'type': 'NO_INTERVENTION', 'label': 'No topical IOP reducing medication', 'description': 'No IOP reducing drops instilled after surgery'}], 'interventions': [{'name': 'Brinzolamide-Brimonidine fixed combination', 'type': 'DRUG', 'otherNames': ['Simbrinza, 0.2%-1% Ophthalmic Suspension'], 'description': 'Simbrinza 0.2%-1% Ophthalmic Suspension', 'armGroupLabels': ['Brinzolamide-Brimonidine fixed combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26504', 'city': 'Pátrai', 'state': 'Achaia', 'country': 'Greece', 'facility': 'University Hospital of Patras', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}], 'overallOfficials': [{'name': 'Constantine Georgakopoulos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical School, University of Patras, Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Patras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor in Ophthalmology', 'investigatorFullName': 'Constantinos D. Georgakopoulos, MD, PhD', 'investigatorAffiliation': 'University Hospital of Patras'}}}}