NCT01417858

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 16, 2011

Status Verified

June 1, 2011

Enrollment Period

1.1 years

First QC Date

August 15, 2011

Last Update Submit

August 15, 2011

Conditions

Glaucoma, Narrow Angle

Keywords

intra-ocular pressureiridectomygonioscopyocular tonometry

Outcome Measures

Primary Outcomes (1)

  • intra-ocular pressure increase

    mean intra-ocular pressure increase after laser peripheral iridotomy

    one year

Study Arms (2)

brimonidine 0.2%

ACTIVE COMPARATOR
Procedure: YAG laser peripheral iridotomy

brimonidine 0.1%

ACTIVE COMPARATOR
Procedure: YAG laser peripheral iridotomy

Interventions

YAG laser peripheral iridotomyPROCEDURE

1 drop 30 minutes before yag laser iridotomy

Also known as: Alphagan
brimonidine 0.2%

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • previous cataract surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Parana

Curitiba, Paraná, 80060-150, Brazil

RECRUITING

Related Publications (10)

  • Brazier DJ. Neodymium-YAG laser iridotomy. J R Soc Med. 1986 Nov;79(11):658-60. doi: 10.1177/014107688607901115.

    PMID: 3795210BACKGROUND

  • 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.

    PMID: 11382625BACKGROUND

  • 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.

    PMID: 16246772BACKGROUND

  • Drake MV. Neodymium:YAG laser iridotomy. Surv Ophthalmol. 1987 Nov-Dec;32(3):171-7. doi: 10.1016/0039-6257(87)90092-0.

    PMID: 3328316BACKGROUND

  • 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.

    PMID: 10464738BACKGROUND

  • 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.

    PMID: 15258021BACKGROUND

  • 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.

    PMID: 6548087BACKGROUND

  • 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.

    PMID: 3513746BACKGROUND

  • 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.

    PMID: 6548856BACKGROUND

  • Wetzel W. Ocular aqueous humor dynamics after photodisruptive laser surgery procedures. Ophthalmic Surg. 1994 May;25(5):298-302.

    PMID: 8058261BACKGROUND

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Lucas Shiokawa, MD

    Universidade Federal do Parana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Shiokawa, MD

CONTACT

55 41 91432398lucasshiokawa@yahoo.com.br

Dayane Issaho, MD

CONTACT

day_issaho@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 16, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2011

Study Completion

July 1, 2012

Last Updated

August 16, 2011

Record last verified: 2011-06

Locations

BR(1)