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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

August 15, 2011
August 15, 2011
November 2010
December 2011   (final data collection date for primary outcome measure)
intra-ocular pressure increase [ Time Frame: one year ] [ Designated as safety issue: No ]
mean intra-ocular pressure increase after laser peripheral iridotomy
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Intraocular Pressure Control After Anterior Segment Laser - Comparison Between 2 Drugs
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Glaucoma, Narrow Angle
  • 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
  • Active Comparator: brimonidine 0.2%
    Intervention: Procedure: YAG laser peripheral iridotomy
  • Active Comparator: brimonidine 0.1%
    Intervention: Procedure: YAG laser peripheral iridotomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
July 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • previous cataract surgery
Both
40 Years and older
No
Contact: Lucas Shiokawa, MD 55 41 91432398 lucasshiokawa@yahoo.com.br
Contact: Dayane Issaho, MD day_issaho@yahoo.com.br
Brazil
 
NCT01417858
0299.0.208.000-10, 2376.270/2010-11
Yes
Lucas Shiokawa, Universidade Federal do Parana
Universidade Federal do Paraná
Not Provided
Principal Investigator: Lucas Shiokawa, MD Universidade Federal do Parana
Universidade Federal do Paraná
June 2011

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