Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy

Phase 4CompletedNCT03192826

University Hospital of Patras79 enrolled

Overview

To compare the efficacy of a Brinzolamide/Brimonidine fixed combination (FC) with Brimonidine 0.2% in preventing intraocular pressure (IOP) elevations after neodymium: yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy.

In this prospective, randomized, double masked clinical trial, patients scheduled to undergo Nd:YAG laser posterior capsulotomy for posterior capsule opacification are randomized in 3 groups. The Brimonidine group receives 1 drop of Brimonidine 0.2%. The Brinzolamide/Brimonidine group receives 1 drop of Brinzolamide 1%/Brimonidine 0.2% fixed combination. The Control group receives artificial tears. All groups are administered a single drop instillation, approximately one hour before Nd:YAG application. Intraocular pressure measurements are performed before treatment (baseline) and at the 1, 3, 24 hours and 1 week post treatment. Dexamethasone ophthalmic drops are prescribed q.i.d. for one week after the procedure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Posterior Capsule Opacification Ocular Hypertension

Interventions

Brinzolamide/Brimonidine FCDRUG

1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy

Brimonidine 0.2%DRUG

1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy

Artificial tearsDRUG

1 drop of artificial tears 1 hour before Nd-YAG capsulotomy

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * patients scheduled to undergo laser posterior capsulotomy due to posterior capsule opacification (PCO) after uneventful phacoemulsification cataract extraction with implantation of posterior chamber intraocular lenses (IOL/PC). Exclusion Criteria: * baseline IOP greater than 21mmHg * glaucomatous eyes, already under treatment with anti glaucomatic medications * intraocular surgery except for uncomplicated cataract surgery * previous photorefractive surgery * active ocular inflammation or infection * patients under systemic administration of medications known to affect IOP * patients with severe respiratory or cardiovascular disease * pregnant or breast feeding women, and individuals with known hypersensitivity or contraindication for administration of the medications tested * a measurement of IOP \> 30 mmHg at any time point of the study, or an increase from baseline \>20 mmHg

Locations (1)

University Hospital of Patras

Pátrai, Achaia, Greece

Outcomes

Primary Outcomes

Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP

Time frame: 1 hour

Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP

Time frame: 3 hours

Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP

Time frame: 24 hours

Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP

Time frame: 1 week

Data from ClinicalTrials.gov

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