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

Study Overview
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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.

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

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: brimonidine 0.1%
* Drug: Apraclonidine 0.5%


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I<br>Eyes receiving Apraclonidine 0.5% (Iopidine) prior to SLT | Drug: Apraclonidine 0.5%<br>* 1 drop applied 1 hour prior to SLT<br>|
| Active Comparator: A<br>Eyes receiving Brimonidine 0.1% (Alphagan) prior to SLT | Drug: brimonidine 0.1%<br>* 1 drop, 1 hour prior to selective laser trabeculoplasty (SLT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative IOP |  | 1 hour and 1 week post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall IOP reduction post SLT |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Laser, laser trabeculoplasty, selective laser trabeculoplasty, intraocular pressure