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

Walter Reed Army Medical Center

Status: Unknown

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: brimonidine 0.1%; Drug: Apraclonidine 0.5%

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00567411

WRAMC WU # 06-23016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 43 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups

I

Active Comparator group

Description:

Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT

Treatment:

Drug: Apraclonidine 0.5%

A

Active Comparator group

Description:

Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT

Treatment:

Drug: brimonidine 0.1%