Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03494257|
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cataract Intraocular Pressure||Drug: Brinzolamide-Brimonidine fixed combination||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective randomized double-masked comparative study|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Patients will be unaware of their groupe assignment. The investigator who will measure the IOP will also be masked to group assignment.|
|Official Title:||Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification|
|Actual Study Start Date :||September 4, 2017|
|Actual Primary Completion Date :||March 20, 2018|
|Actual Study Completion Date :||April 6, 2018|
Active Comparator: Brinzolamide-Brimonidine fixed combination
1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery
Drug: Brinzolamide-Brimonidine fixed combination
Simbrinza 0.2%-1% Ophthalmic Suspension
Other Name: Simbrinza, 0.2%-1% Ophthalmic Suspension
No Intervention: No topical IOP reducing medication
No IOP reducing drops instilled after surgery
- IOP at 6 hours after surgery [ Time Frame: 6 hours postoperatively ]IOP will be measured by the same Goldman applanation tonometer used preoperatively
- IOP at 12 hours after surgery [ Time Frame: 12 hours postoperatively ]IOP will be measured by the same Goldman applanation tonometer used preoperatively
- IOP at 24 hours after surgery [ Time Frame: 12 hours postoperatively ]IOP will be measured by the same Goldman applanation tonometer used preoperatively
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494257
|University Hospital of Patras|
|Patra, Achaia, Greece, 26504|
|Principal Investigator:||Constantine Georgakopoulos, MD, PhD||Medical School, University of Patras, Greece|