Clinical trial NCT01417858: Intraocular Pressure Control After Anterior Segment Laser - Comparison Between 2 Drugs
Official title: Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Narrow Angle
Keywords: intra-ocular pressure
iridectomy
gonioscopy
ocular tonometry
Lead sponsor: Universidade Federal do Paraná
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* previous cataract surgery

Primary outcomes:
measure: intra-ocular pressure increase
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Universidade Federal do Parana
state: Parana
Study officials:
affiliation: Universidade Federal do Parana
name: Lucas Shiokawa, MD
role: PRINCIPAL_INVESTIGATOR
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