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

August 15, 2011 updated by: Universidade Federal do Paraná

Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Parana
      • Curitiba, Parana, Brazil, 80060-150
        • Recruiting
        • Universidade Federal do Paraná
        • Principal Investigator:
          • Lucas Shiokawa
        • Principal Investigator:
          • Lisandro Sakata
        • Principal Investigator:
          • Dayane Issaho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • previous cataract surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: brimonidine 0.2%
Procedure: YAG laser peripheral iridotomy
1 drop 30 minutes before yag laser iridotomy
Other Names:
  • Alphagan z
ACTIVE_COMPARATOR: brimonidine 0.1%
Procedure: YAG laser peripheral iridotomy
1 drop 30 minutes before yag laser iridotomy
Other Names:
  • Alphagan z

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intra-ocular pressure increase
Time Frame: one year
mean intra-ocular pressure increase after laser peripheral iridotomy
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Paraná

Investigators

  • Principal Investigator: Lucas Shiokawa, MD, Universidade Federal do Paraná

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

July 1, 2012

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (ESTIMATE)

August 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2011

Last Update Submitted That Met QC Criteria

August 15, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0299.0.208.000-10
  • 2376.270/2010-11 (OTHER: Hospital de Clinicas - UFPR - Research Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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