Clinical trial NCT03494257: Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
Official title: Effect of Fixed Brinzolamide-brimonidine Combination on Intraocular Pressure After Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Intraocular Pressure
Keywords: phacoemulsification
intraocular pressure
cataract
brinzolamide
brimonidinde
fixed combination
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 62
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized double-masked comparative study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: IOP at 6 hours after surgery
timeFrame: 6 hours postoperatively
Secondary outcomes:
measure: IOP at 12 hours after surgery
timeFrame: 12 hours postoperatively
measure: IOP at 24 hours after surgery
timeFrame: 12 hours postoperatively
Other outcomes:
Locations:
city: Patra
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
affiliation: Medical School, University of Patras, Greece
name: Constantine Georgakopoulos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: