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

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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