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

Glaucoma, Narrow Angle Clinical Trial

Official title:

Short-term Intraocular Pressure Control After YAG Iridotomy - Comparison Between Brimonidine 0.1% vs. 0.2%

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01417858
• Other study ID #: 0299.0.208.000-10
• Secondary ID: 2376.270/2010-11
• Status: Recruiting
• Phase: N/A
• First received: August 15, 2011
• Last updated: August 15, 2011
• Start date: November 2010
• Est. completion date: July 2012

Study information

• Verified date: June 2011
• Source: Universidade Federal do Paraná
• Contact: Lucas Shiokawa, MD
• Phone: 55 41 91432398
• Email: lucasshiokawa[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• previous cataract surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glaucoma, Angle-Closure
• Glaucoma, Narrow Angle

Intervention

Procedure:
• YAG laser peripheral iridotomy
1 drop 30 minutes before yag laser iridotomy
• YAG laser peripheral iridotomy
1 drop 30 minutes before yag laser iridotomy

Locations

Country	Name	City	State
Brazil	Universidade Federal do Parana	Curitiba	Parana

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Paraná

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

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

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra-ocular pressure increase	mean intra-ocular pressure increase after laser peripheral iridotomy	one year	No