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

• Sponsor: Universidade Federal do Paraná (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01417858
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 2.5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Narrow Angle	Procedure: YAG laser peripheral iridotomy; Procedure: YAG laser peripheral iridotomy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%
• Study Start Date: Nov 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2011
• Anticipated Study Completion Date: Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: brimonidine 0.2%	Procedure: YAG laser peripheral iridotomy; 1 drop 30 minutes before yag laser iridotomy; Other Names: Alphagan
Active Comparator: brimonidine 0.1%	Procedure: YAG laser peripheral iridotomy; 1 drop 30 minutes before yag laser iridotomy; Other Names: Alphagan z

Outcome Measures

Primary Outcome Measures

1. intra-ocular pressure increase [one year]

   mean intra-ocular pressure increase after laser peripheral iridotomy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• previous cataract surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Federal do Parana	Curitiba	Parana	Brazil	80060-150

Sponsors and Collaborators

• Universidade Federal do Paraná

Investigators

• Principal Investigator: Lucas Shiokawa, MD, Universidade Federal do Parana

Study Documents (Full-Text)

None provided.

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.

• ClinicalTrials.gov Identifier: NCT01417858
• Other Study ID Numbers: 0299.0.208.000-10; 2376.270/2010-11
• First Posted: Aug 16, 2011
• Last Update Posted: Aug 16, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by , ,: intra-ocular pressure; iridectomy; gonioscopy; ocular tonometry
• Additional relevant MeSH terms: Glaucoma, Angle-Closure; Brimonidine Tartrate

Study Results

No Results Posted as of Aug 16, 2011