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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Universidade Federal do Paraná.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01417858
First Posted: August 16, 2011
Last Update Posted: August 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidade Federal do Paraná
  Purpose
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).

Condition Intervention
Glaucoma, Narrow Angle Procedure: YAG laser peripheral iridotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Paraná:

Primary Outcome Measures:
  • intra-ocular pressure increase [ Time Frame: one year ]
    mean intra-ocular pressure increase after laser peripheral iridotomy


Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: brimonidine 0.2% Procedure: YAG laser peripheral iridotomy
1 drop 30 minutes before yag laser iridotomy
Other Name: Alphagan
Active Comparator: brimonidine 0.1% Procedure: YAG laser peripheral iridotomy
1 drop 30 minutes before yag laser iridotomy
Other Name: Alphagan z

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • previous cataract surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01417858


Contacts
Contact: Lucas Shiokawa, MD 55 41 91432398 lucasshiokawa@yahoo.com.br
Contact: Dayane Issaho, MD day_issaho@yahoo.com.br

Locations
Brazil
Universidade Federal do Parana Recruiting
Curitiba, Parana, Brazil, 80060-150
Principal Investigator: Lucas Shiokawa         
Principal Investigator: Lisandro Sakata         
Principal Investigator: Dayane Issaho         
Sponsors and Collaborators
Universidade Federal do Paraná
Investigators
Principal Investigator: Lucas Shiokawa, MD Universidade Federal do Parana
  More Information

Publications:

Responsible Party: Lucas Shiokawa, Universidade Federal do Parana
ClinicalTrials.gov Identifier: NCT01417858     History of Changes
Other Study ID Numbers: 0299.0.208.000-10
2376.270/2010-11 ( Other Identifier: Hospital de Clinicas - UFPR - Research Ethics Committee )
First Submitted: August 15, 2011
First Posted: August 16, 2011
Last Update Posted: August 16, 2011
Last Verified: June 2011

Keywords provided by Universidade Federal do Paraná:
intra-ocular pressure
iridectomy
gonioscopy
ocular tonometry

Additional relevant MeSH terms:
Glaucoma, Angle-Closure
Glaucoma
Ocular Hypertension
Eye Diseases
Brimonidine Tartrate
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs