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

Not Applicable

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Apraclonidine 0.5%; Drug: brimonidine 0.1%

• Registration Number: NCT00567411
• Lead Sponsor: Walter Reed Army Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-08
• Status Verified: 2007-11
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Last Update Submitted: 2007-12-04
• Study First Posted: 2007-12-05
• Last Update Posted: 2007-12-05
• Study Completion: 2009-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Apraclonidine 0.5%	Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT
A	brimonidine 0.1%	Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT

Primary Outcome Measures

Name	Time	Method
Postoperative IOP	1 hour and 1 week post surgery

Secondary Outcome Measures

Name	Time	Method
Overall IOP reduction post SLT	1 month

Trial Locations

Locations (1)

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States