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

University Hospital of Patras

Status: Completed

Conditions: Cataract; Intraocular Pressure

Treatments: Drug: Brinzolamide-Brimonidine fixed combination

Study type: Interventional

Funder types: Other

Identifiers

NCT03494257

58/15.02.2018/5104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Brinzolamide-Brimonidine fixed combination

Active Comparator group

Description:

1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery

Treatment:

Drug: Brinzolamide-Brimonidine fixed combination

No topical IOP reducing medication

No Intervention group

Description:

No IOP reducing drops instilled after surgery