Clinical trial NCT03192826: Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy
Official title: Study of the Efficacy of Brinzolamide 1% Plus Brimonidine 0.2% Versus Brimonidine 0.2% in the Prevention of Intraocular Pressure Rise After Nd-YAG Laser Capsulotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Posterior Capsule Opacification
Ocular Hypertension
Keywords: Nd-YAG capsulotomy
ocular hypertension
brimonidine
brinzolamide
Lead sponsor: University Hospital of Patras
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 79
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized, double masked comparative study
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy
timeFrame: 1 hour
measure: Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy
timeFrame: 3 hours
measure: Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy
timeFrame: 24 hours
measure: Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Patra
country: Greece
facility: University Hospital of Patras
state: Achaia
Study officials:
affiliation: University Hospital of Patras
name: Constantinos Georgakopoulos, MD, PhD
role: STUDY_DIRECTOR
References: