Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

Study Overview
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Brief Summary
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The type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will evaluate the IOP lowering effect of SLT following the topical administration of one of the following: prednisolone 1%, ketorolac 0.5% or artificial tears.

Detailed Description
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Patients who have been chosen to undergo SLT for glaucoma will be randomized to receive one of prednisolone 1%, ketorolac 0.5% or artificial tears four times a day for 5 days following administration of the laser treatment. The IOP will be measured at various time points following SLT: 1 hour, 2 days, 1 week, 1 month, 3 months, 6 months, and 1 year.

Official Title
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Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study

Conditions
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Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma

Intervention / Treatment
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* Drug: prednisolone 1%
* Drug: ketorolac 0.5%
* Drug: Artificial Tears (Methyl cellulose drops)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary open angle glaucoma, pseudo exfoliation glaucoma Exclusion Criteria: previous incisional glaucoma surgery

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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Accepts Healthy Volunteers

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: 1<br>Prednisolone 1% eye drop | Drug: prednisolone 1%<br>* eye drop once in each eye treated, 4 times / day for 5 days post-laser<br>|
| Active Comparator: 2<br>ketorolac 0.5% eye drop | Drug: ketorolac 0.5%<br>* eye drop once in each eye treated, 4 times / day for 5 days post-laser<br>* Other names: Acular;|
| Placebo Comparator: 3<br>Artificial Tears (methyl cellulose eye drop) | Drug: Artificial Tears (Methyl cellulose drops)<br>* eye drop once in each eye treated, 4 times / day for 5 days post-laser<br>* Other names: Refresh Tears;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure lowering effect |  | 1 hour, 2 days, 1 month, 3 months, 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure elevation |  | 1 hour, 2 days, 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary open angle glaucoma, pseudoexfoliation glaucoma, selective laser trabeculoplasty, intra ocular pressure, anti-inflammatory therapy, prednisolone acetate 1%, ketorolac tromethamine 0.5%