Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the effect of fixed brinzolamide-brimonidine combination on intaocular pressure after uncomplicated phacoemulsification surgery. 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.

Detailed Description
-----------------
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. 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.

Official Title
-----------------
Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification

Conditions
-----------------
Cataract, Intraocular Pressure

Intervention / Treatment
-----------------
* Drug: Brinzolamide-Brimonidine fixed combination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo cataract surgery by phacoemulsification. Exclusion Criteria: previous ocular surgery 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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized double-masked comparative study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brinzolamide-Brimonidine fixed combination<br>1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery | Drug: Brinzolamide-Brimonidine fixed combination<br>* Simbrinza 0.2%-1% Ophthalmic Suspension<br>* Other names: Simbrinza, 0.2%-1% Ophthalmic Suspension;|
| No Intervention: No topical IOP reducing medication<br>No IOP reducing drops instilled after surgery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP at 6 hours after surgery | IOP will be measured by the same Goldman applanation tonometer used preoperatively | 6 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP at 12 hours after surgery | IOP will be measured by the same Goldman applanation tonometer used preoperatively | 12 hours postoperatively | 
| IOP at 24 hours after surgery | IOP will be measured by the same Goldman applanation tonometer used preoperatively | 12 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phacoemulsification, intraocular pressure, cataract, brinzolamide, brimonidinde, fixed combination