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

Primary Purpose

Glaucoma, Narrow Angle

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
YAG laser peripheral iridotomy
YAG laser peripheral iridotomy
Sponsored by
Universidade Federal do Paraná
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Glaucoma, Narrow Angle focused on measuring intra-ocular pressure, iridectomy, gonioscopy, ocular tonometry

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • previous cataract surgery

Sites / Locations

  • Universidade Federal do ParanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

brimonidine 0.2%

brimonidine 0.1%

Arm Description

Outcomes

Primary Outcome Measures

intra-ocular pressure increase
mean intra-ocular pressure increase after laser peripheral iridotomy

Secondary Outcome Measures

Full Information

First Posted
August 15, 2011
Last Updated
August 15, 2011
Sponsor
Universidade Federal do Paraná
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1. Study Identification

Unique Protocol Identification Number
NCT01417858
Brief Title
Intraocular Pressure Control After Anterior Segment Laser - Comparison Between 2 Drugs
Official Title
Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universidade Federal do Paraná

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Narrow Angle
Keywords
intra-ocular pressure, iridectomy, gonioscopy, ocular tonometry

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
brimonidine 0.2%
Arm Type
Active Comparator
Arm Title
brimonidine 0.1%
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
YAG laser peripheral iridotomy
Other Intervention Name(s)
Alphagan
Intervention Description
1 drop 30 minutes before yag laser iridotomy
Intervention Type
Procedure
Intervention Name(s)
YAG laser peripheral iridotomy
Other Intervention Name(s)
Alphagan z
Intervention Description
1 drop 30 minutes before yag laser iridotomy
Primary Outcome Measure Information:
Title
intra-ocular pressure increase
Description
mean intra-ocular pressure increase after laser peripheral iridotomy
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: bilateral narrow angles, defined by irido-trabecular contact in >180o on gonioscopy Exclusion Criteria: previous cataract surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas Shiokawa, MD
Phone
55 41 91432398
Email
lucasshiokawa@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Dayane Issaho, MD
Email
day_issaho@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas Shiokawa, MD
Organizational Affiliation
Universidade Federal do Parana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Parana
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060-150
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Shiokawa
First Name & Middle Initial & Last Name & Degree
Lisandro Sakata
First Name & Middle Initial & Last Name & Degree
Dayane Issaho

12. IPD Sharing Statement

Citations:
PubMed Identifier
3795210
Citation
Brazier DJ. Neodymium-YAG laser iridotomy. J R Soc Med. 1986 Nov;79(11):658-60. doi: 10.1177/014107688607901115.
Results Reference
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PubMed Identifier
11382625
Citation
Chen TC, Ang RT, Grosskreutz CL, Pasquale LR, Fan JT. Brimonidine 0.2% versus apraclonidine 0.5% for prevention of intraocular pressure elevations after anterior segment laser surgery. Ophthalmology. 2001 Jun;108(6):1033-8. doi: 10.1016/s0161-6420(01)00545-0.
Results Reference
background
PubMed Identifier
16246772
Citation
Chen TC. Brimonidine 0.15% versus apraclonidine 0.5% for prevention of intraocular pressure elevation after anterior segment laser surgery. J Cataract Refract Surg. 2005 Sep;31(9):1707-12. doi: 10.1016/j.jcrs.2005.02.035.
Results Reference
background
PubMed Identifier
3328316
Citation
Drake MV. Neodymium:YAG laser iridotomy. Surv Ophthalmol. 1987 Nov-Dec;32(3):171-7. doi: 10.1016/0039-6257(87)90092-0.
Results Reference
background
PubMed Identifier
10464738
Citation
Hartenbaum D, Wilson H, Maloney S, Vacarelli L, Orillac R, Sharpe E. A randomized study of dorzolamide in the prevention of elevated intraocular pressure after anterior segment laser surgery. Dorzolamide Laser Study Group. J Glaucoma. 1999 Aug;8(4):273-5.
Results Reference
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PubMed Identifier
15258021
Citation
Kashiwagi K, Abe K, Tsukahara S. Quantitative evaluation of changes in anterior segment biometry by peripheral laser iridotomy using newly developed scanning peripheral anterior chamber depth analyser. Br J Ophthalmol. 2004 Aug;88(8):1036-41. doi: 10.1136/bjo.2003.036715.
Results Reference
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PubMed Identifier
6548087
Citation
Khodadoust AA, Arkfeld DF, Caprioli J, Sears ML. Ocular effect of neodymium-YAG laser. Am J Ophthalmol. 1984 Aug 15;98(2):144-52. doi: 10.1016/0002-9394(87)90348-5.
Results Reference
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PubMed Identifier
3513746
Citation
Robin AL, Arkell S, Gilbert SM, Goossens AA, Werner RP, Korshin OM. Q-switched neodymium-YAG laser iridotomy. A field trial with a portable laser system. Arch Ophthalmol. 1986 Apr;104(4):526-30. doi: 10.1001/archopht.1986.01050160082017.
Results Reference
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PubMed Identifier
6548856
Citation
Schrems W, Eichelbronner O, Krieglstein GK. The immediate IOP response of Nd-YAG-laser iridotomy and its prophylactic treatability. Acta Ophthalmol (Copenh). 1984 Oct;62(5):673-80. doi: 10.1111/j.1755-3768.1984.tb05794.x.
Results Reference
background
PubMed Identifier
8058261
Citation
Wetzel W. Ocular aqueous humor dynamics after photodisruptive laser surgery procedures. Ophthalmic Surg. 1994 May;25(5):298-302.
Results Reference
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Intraocular Pressure Control After Anterior Segment Laser - Comparison Between 2 Drugs

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