Intraocular Pressure Control After Anterior Segment Laser - Comparison Between 2 Drugs

Not Applicable

• Conditions: Glaucoma, Narrow Angle
• Interventions: Procedure: YAG laser peripheral iridotomy

• Registration Number: NCT01417858
• Lead Sponsor: Universidade Federal do Paraná

Brief Summary

The purpose of this study is to compare the intra-ocular (IOP) control efficacy between brimonidine 0.1% vs. 0.2% after laser peripheral iridotomy (LPI).

Detailed Description

Postoperative IOP elevation is one of the most common complications after LPI.Previous studies showed that brimonidine 0.2% is effective in blunting IOP spikes after LPI.This prospective randomized double-masked interventional study will include patients with bilateral narrow angles, defined by irido-trabecular contact in \>180o on gonioscopy.Pilocarpine 1% will be used in both eyes, and 30 minutes later, brimonidine 0.1% randomly used in one eye and brimonidine 0.2% in the contra-lateral eye. LPI with Nd:YAG laser is performed 30 minutes later in both eyes by a single glaucoma specialist. IOP measurements are assessed before the use of any eyedrop (basal IOP), 30 minutes after pilocarpine (pre-brimonidine), and 30, 60, 120, 180 minutes after LPI. Pachymetry, ultrasonic biometry, gonioscopy, and total YAG laser energy are recorded. Non-parametric test will be used for analysis.

Study Timeline

• Study Start: 2010-11
• Status Verified: 2011-06
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-15
• Last Update Submitted: 2011-08-15
• Study First Posted: 2011-08-16
• Last Update Posted: 2011-08-16
• Primary Completion: 2011-12
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• bilateral narrow angles, defined by irido-trabecular contact in >180o on gonioscopy

Exclusion Criteria

• previous cataract surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
brimonidine 0.2%	YAG laser peripheral iridotomy	-
brimonidine 0.1%	YAG laser peripheral iridotomy	-

Primary Outcome Measures

Name	Time	Method
intra-ocular pressure increase	one year	mean intra-ocular pressure increase after laser peripheral iridotomy

Trial Locations

Locations (1)

Universidade Federal do Parana; 🇧🇷 Curitiba, Parana, Brazil