Steroids After Laser Trabeculoplasty for Glaucoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the choice of post-operative eye drop administered after selective laser trabeculoplasty (SLT) for glaucoma affects the efficacy in lowering intraocular pressure (IOP).

Detailed Description
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SLT is used to lower intraocular pressure in glaucoma, but it is not know whether the choice of eyedrops administered in the post-operative period affects SLT efficacy. Practitioners commonly use steroid drops, non-steroidal anti-inflammatory drops, or no drops at all. This is a randomized, single-center, prospective, masked clinical trial to determine whether the choice of eyedrop affects efficacy of SLT in glaucoma patients.

Official Title
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Steroids And Laser Trabeculoplasty (SALT) Trial: Effect of Anti-Inflammatory Treatment on the Efficacy of SLT

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Prednisolone 1%
* Drug: Ketorolac
* Drug: Artificial Tears


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of glaucoma clinician has determined that SLT laser is indicated IOP currently >18 and was ever >21 in the past (e.g. prior to treatment) Exclusion Criteria: prior history of uveitis prior glaucoma surgery including glaucoma laser surgery pregnant or 3 months post-partum

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial Tears<br>Topical artificial tears dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. | Drug: Artificial Tears<br>* Artificial saline tears to lasered eye 4 times/day for 4.5 days<br>* Other names: saline tears;|
| Experimental: Non-steroidal anti-inflammatory<br>Topical ketorolac 0.5% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. | Drug: Ketorolac<br>* Ketorolac 0.5% to lasered eye 4 times/day for 4.5 days<br>* Other names: Voltaren;|
| Experimental: Steroid<br>Topical prednisolone 1% dosed 4 times per day for 4 days in treated eye after laser trabeculoplasty. | Drug: Prednisolone 1%<br>* Prednisolone 1% to lasered eye 4 times/day for 4.5 days<br>* Other names: Pred forte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) Change | IOP will be measured before and at 6 and 12 weeks after intervention using Goldman tonometry. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Inflammation | The count of patients with inflammation defined as anterior chamber cells was measured in each study arm. | Up to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Trabeculoplasty, Selective laser trabeculoplasty, Intraocular pressure