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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Universidade Federal do Paraná.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Universidade Federal do Paraná
ClinicalTrials.gov Identifier:
NCT01417858
First received: August 15, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 15, 2011
Last Updated: August 15, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on November 20, 2014