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

April 9, 2018 updated by: Constantinos D. Georgakopoulos, MD, PhD, University Hospital of Patras

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Achaia
      • Patra, Achaia, Greece, 26504
        • University Hospital of Patras

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Brinzolamide-Brimonidine fixed combination
1 drop of the brinzolamide-brimonidine fixed combination instilled in the patients cul de sac immediately after surgery
Drug: Brinzolamide-Brimonidine fixed combination
Simbrinza 0.2%-1% Ophthalmic Suspension
Other Names:
  • Simbrinza, 0.2%-1% Ophthalmic Suspension
NO_INTERVENTION: No topical IOP reducing medication
No IOP reducing drops instilled after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP at 6 hours after surgery
Time Frame: 6 hours postoperatively
IOP will be measured by the same Goldman applanation tonometer used preoperatively
6 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP at 12 hours after surgery
Time Frame: 12 hours postoperatively
IOP will be measured by the same Goldman applanation tonometer used preoperatively
12 hours postoperatively
IOP at 24 hours after surgery
Time Frame: 12 hours postoperatively
IOP will be measured by the same Goldman applanation tonometer used preoperatively
12 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Patras

Investigators

  • Principal Investigator: Constantine Georgakopoulos, MD, PhD, Medical School, University of Patras, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 4, 2017

Primary Completion (ACTUAL)

March 20, 2018

Study Completion (ACTUAL)

April 6, 2018

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 9, 2018

First Posted (ACTUAL)

April 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58/15.02.2018/5104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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