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

Not Applicable

Completed

• Conditions: Cataract; Intraocular Pressure
• Interventions: Drug: Brinzolamide-Brimonidine fixed combination

• Registration Number: NCT03494257
• Lead Sponsor: University Hospital of Patras

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.

Study Timeline

• Study Start: 2017-09-04
• Primary Completion: 2018-03-20
• Status Verified: 2018-04
• Study First Submitted: 2018-04-02
• Study Completion: 2018-04-06
• Study First Submitted QC: 2018-04-09
• Last Update Submitted: 2018-04-09
• Study First Posted: 2018-04-11
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brinzolamide-Brimonidine fixed combination	Brinzolamide-Brimonidine fixed combination	1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery

Primary Outcome Measures

Name	Time	Method
IOP at 6 hours after surgery	6 hours postoperatively	IOP will be measured by the same Goldman applanation tonometer used preoperatively

Secondary Outcome Measures

Name	Time	Method
IOP at 12 hours after surgery	12 hours postoperatively	IOP will be measured by the same Goldman applanation tonometer used preoperatively
IOP at 24 hours after surgery	12 hours postoperatively	IOP will be measured by the same Goldman applanation tonometer used preoperatively

Trial Locations

Locations (1)

University Hospital of Patras; 🇬🇷 Patra, Achaia, Greece