Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
NCT ID: NCT03494257
Last Updated: 2018-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2017-09-04
2018-04-06
Brief Summary
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Patients scheduled for phacoemulsification will be randomly assigned to 1 of 2 groups.
The 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.
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Detailed Description
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OVDs 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.
DuoVisc, 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.
To 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Brinzolamide-Brimonidine fixed combination
1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery
Brinzolamide-Brimonidine fixed combination
Simbrinza 0.2%-1% Ophthalmic Suspension
No topical IOP reducing medication
No IOP reducing drops instilled after surgery
No interventions assigned to this group
Interventions
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Brinzolamide-Brimonidine fixed combination
Simbrinza 0.2%-1% Ophthalmic Suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* ocular hypertension
* pseudoexfoliation syndrome
* pigment dispersion syndrome
* glaucoma
* history of severe cardiovascular disease, cerebral or coronary insufficiency, depression, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans
* hypersensitivity to sulfonamides or brimonidine
45 Years
ALL
No
Sponsors
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University Hospital of Patras
OTHER
Responsible Party
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Constantinos D. Georgakopoulos, MD, PhD
Associate Professor in Ophthalmology
Principal Investigators
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Constantine Georgakopoulos, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical School, University of Patras, Greece
Locations
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University Hospital of Patras
Pátrai, Achaia, Greece
Countries
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Other Identifiers
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58/15.02.2018/5104
Identifier Type: -
Identifier Source: org_study_id
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