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

U

Universidade Federal do Paraná

Status

Unknown

Conditions

Glaucoma, Narrow Angle

Treatments

Procedure: YAG laser peripheral iridotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT01417858
2376.270/2010-11 (Other Identifier)
0299.0.208.000-10

Details and patient eligibility

About

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).

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • previous cataract surgery

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

brimonidine 0.2%
Active Comparator group
Treatment:
Procedure: YAG laser peripheral iridotomy
Procedure: YAG laser peripheral iridotomy
brimonidine 0.1%
Active Comparator group
Treatment:
Procedure: YAG laser peripheral iridotomy
Procedure: YAG laser peripheral iridotomy

Trial contacts and locations

1

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Central trial contact

Dayane Issaho, MD; Lucas Shiokawa, MD

Data sourced from clinicaltrials.gov

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