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Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty

NCT ID: NCT00567411

Last Updated: 2007-12-05

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

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-06-30

Brief Summary

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The purpose of the study is to compare the safety and efficacy of two drops used to lower eye pressure when given prior to a glaucoma laser procedure.

Detailed Description

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This is a prospective randomized double blind trial of patients undergoing selective laser trabeculoplasty for primary open angle glaucoma and ocular hypertension. Enrolled patients are randomized to receive one drop of brimonidine 0.1% in one eye and one drop of apraclonidine 0.5% in the fellow eye. The trabecular meshwork in both eyes of each enrolled patient is treated 360 degrees at the same sitting. Intraocular pressure is measured in each eye one hour before applying the study medications and at one hour and one week after laser surgery.

Conditions

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Glaucoma Ocular Hypertension

Keywords

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Glaucoma Laser laser trabeculoplasty selective laser trabeculoplasty intraocular pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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I

Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT

Group Type ACTIVE_COMPARATOR

Apraclonidine 0.5%

Intervention Type DRUG

1 drop applied 1 hour prior to SLT

A

Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT

Group Type ACTIVE_COMPARATOR

brimonidine 0.1%

Intervention Type DRUG

1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)

Interventions

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brimonidine 0.1%

1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)

Intervention Type DRUG

Apraclonidine 0.5%

1 drop applied 1 hour prior to SLT

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* male or female, at least 18 years of age
* Open Angle Glaucoma with inadequate intraocular pressure (IOP) control or evidence of progression (based on optic nerve head appearance and/or visual field changes) despite current medical therapy
* Ocular Hypertension requiring lowering of IOP
* ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria

* inability to understand and provide informed consent to participate in this study
* inability/unwillingness to follow study instructions and complete all required visits
* Documented allergy to either brimonidine or iopidine
* Angle Closure Glaucoma
* Congenital/Juvenile Glaucoma
* Neovascular Glaucoma
* Active uveitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Walter Reed Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Ophthalmology Service, Department of Surgery, Walter Reed Army Medical Center

Principal Investigators

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Vladimir S Yakopson, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed AMC

Locations

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Walter Reed Army Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vladimir S Yakopson, MD

Role: CONTACT

Phone: 202-782-6965

Email: [email protected]

Facility Contacts

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Vladimir S Yakopson, MD

Role: primary

Other Identifiers

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WRAMC WU # 06-23016

Identifier Type: -

Identifier Source: org_study_id