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

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ClinicalTrials.gov Identifier: NCT01417858
Recruitment Status : Unknown
Verified June 2011 by Universidade Federal do Paraná.
Recruitment status was:  Recruiting
First Posted : August 16, 2011
Last Update Posted : August 16, 2011
Sponsor:
Information provided by:
Universidade Federal do Paraná

Tracking Information
First Submitted Date  ICMJE August 15, 2011
First Posted Date  ICMJE August 16, 2011
Last Update Posted Date August 16, 2011
Study Start Date  ICMJE November 2010
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2011)
intra-ocular pressure increase [ Time Frame: one year ]
mean intra-ocular pressure increase after laser peripheral iridotomy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraocular Pressure Control After Anterior Segment Laser - Comparison Between 2 Drugs
Official Title  ICMJE Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Glaucoma, Narrow Angle
Intervention  ICMJE
  • Procedure: YAG laser peripheral iridotomy
    1 drop 30 minutes before yag laser iridotomy
    Other Name: Alphagan
  • Procedure: YAG laser peripheral iridotomy
    1 drop 30 minutes before yag laser iridotomy
    Other Name: Alphagan z
Study Arms  ICMJE
  • Active Comparator: brimonidine 0.2%
    Intervention: Procedure: YAG laser peripheral iridotomy
  • Active Comparator: brimonidine 0.1%
    Intervention: Procedure: YAG laser peripheral iridotomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 15, 2011)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2012
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • previous cataract surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01417858
Other Study ID Numbers  ICMJE 0299.0.208.000-10
2376.270/2010-11 ( Other Identifier: Hospital de Clinicas - UFPR - Research Ethics Committee )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lucas Shiokawa, Universidade Federal do Parana
Study Sponsor  ICMJE Universidade Federal do Paraná
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lucas Shiokawa, MD Universidade Federal do Parana
PRS Account Universidade Federal do Paraná
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP