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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192826
• Other study ID #: 8393 / 26- 4- 2016
• Status: Completed
• Phase: Phase 4
• Start date: June 20, 2016
• Est. completion date: July 8, 2017

Study information

• Verified date: June 2019
• Source: University Hospital of Patras
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 8, 2017
• Est. primary completion date: July 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Hypertension
• Ocular Hypertension
• Posterior Capsule Opacification

Intervention

Drug:
• Brinzolamide/Brimonidine FC
1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
• Brimonidine 0.2%
1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
• Artificial tears
1 drop of artificial tears 1 hour before Nd-YAG capsulotomy

Locations

Country	Name	City	State
Greece	University Hospital of Patras	Patra	Achaia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 hour
Primary	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	3 hours
Primary	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	24 hours
Primary	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	1 week