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

NCT ID: NCT01417858

Last Updated: 2011-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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Glaucoma, Narrow Angle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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brimonidine 0.2%

Group Type ACTIVE_COMPARATOR

YAG laser peripheral iridotomy

Intervention Type PROCEDURE

1 drop 30 minutes before yag laser iridotomy

brimonidine 0.1%

Group Type ACTIVE_COMPARATOR

YAG laser peripheral iridotomy

Intervention Type PROCEDURE

1 drop 30 minutes before yag laser iridotomy

Interventions

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YAG laser peripheral iridotomy

1 drop 30 minutes before yag laser iridotomy

Intervention Type PROCEDURE

YAG laser peripheral iridotomy

1 drop 30 minutes before yag laser iridotomy

Intervention Type PROCEDURE

Other Intervention Names

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Alphagan Alphagan z

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* previous cataract surgery
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do ParanĂ¡

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal do Parana

Principal Investigators

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Lucas Shiokawa, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Parana

Locations

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Universidade Federal do Parana

Curitiba, ParanĂ¡, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Lucas Shiokawa, MD

Role: CONTACT

55 41 91432398

Dayane Issaho, MD

Role: CONTACT

References

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

Reference Type BACKGROUND
PMID: 3795210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11382625 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16246772 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 3328316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10464738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15258021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6548087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3513746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6548856 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8058261 (View on PubMed)

Other Identifiers

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2376.270/2010-11

Identifier Type: OTHER

Identifier Source: secondary_id

0299.0.208.000-10

Identifier Type: -

Identifier Source: org_study_id

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