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

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:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Brimonidine tartrate

U.S. FDA Resources

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

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:

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

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.

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.

Drake MV. Neodymium:YAG laser iridotomy. Surv Ophthalmol. 1987 Nov-Dec;32(3):171-7. Review.

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.

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.

Khodadoust AA, Arkfeld DF, Caprioli J, Sears ML. Ocular effect of neodymium-YAG laser. Am J Ophthalmol. 1984 Aug 15;98(2):144-52.

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.

Schrems W, Eichelbrönner 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.

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

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
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013