Skip to main content
Clinical Trials/NCT03494257
NCT03494257CompletedNot Applicable

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

University Hospital of Patras1 site in 1 country62 target enrollmentStarted: September 4, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
62
Locations
1
Primary Endpoint
IOP at 6 hours after surgery

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
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.

Eligibility Criteria

Ages
45 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients scheduled to undergo cataract surgery by phacoemulsification.

Exclusion Criteria

  • previous ocular surgery
  • ocular hypertension
  • pseudoexfoliation syndrome
  • pigment dispersion syndrome
  • history of severe cardiovascular disease, cerebral or coronary insufficiency, depression, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans
  • hypersensitivity to sulfonamides or brimonidine

Arms & Interventions

Brinzolamide-Brimonidine fixed combination

Active Comparator

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

Intervention: Brinzolamide-Brimonidine fixed combination (Drug)

Outcomes

Primary Outcomes

IOP at 6 hours after surgery

Time Frame: 6 hours postoperatively

IOP will be measured by the same Goldman applanation tonometer used preoperatively

Secondary Outcomes

  • IOP at 12 hours after surgery(12 hours postoperatively)
  • IOP at 24 hours after surgery(12 hours postoperatively)

Investigators

Sponsor
University Hospital of Patras
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Constantinos D. Georgakopoulos, MD, PhD

Associate Professor in Ophthalmology

University Hospital of Patras

Study Sites (1)

Loading locations...

Similar Trials