Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma

Study Overview
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Brief Summary
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The present study's main objective is to assess if there is a significant difference between either of the treatments frequently used in post-op, namely a topic cortisone-based treatment, an non-steroidal anti-inflammatory drug (NSAID) or simply a placebo, in order to gain the best long term (6 months) efficacy of the SLT.

Detailed Description
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The selective laser trabeculoplasty (SLT) is the laser treatment of choice for treating glaucoma. A There is however a controversy regarding the use of drops post-treatment. Indeed, some would prefer not to pharmacologically modulate the post-op inflammatory response which can be an integral part of the treatment by favouring the mobilisation of the macrophages which participate to the trabeculae cleaning. Others will prefer to calm the inflammatory reaction and choose an anti-inflammatory drug (either steroidal or non-steroidal).

Official Title
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Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma

Conditions
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Glaucoma, Inflammatory Response

Intervention / Treatment
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* Procedure: Selective Laser trabeculoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from with primary open-angle glaucoma. Patients with IOP > 21 mmHg, uncontrolled with medical treatment or due to non-compliance, or to whom this is the first glaucoma treatment. Patients > 18 years old, able to consent. Patients consenting to the trial. Exclusion Criteria: Patients suffering from chronic glaucoma other than primary open-angle glaucoma Patients who had changes done to their anti-glaucoma treatments over the last 6 weeks or following the SLT Patients under oral corticosteroid treatment at the time of the operation or those who have stopped during the preceding month. Patients suffering from an important corneal disease which interferes with the capacity to visualize the entire trabeculae. Monophthalmic patients. Patients who already underwent a glaucoma treatment to the eye requiring treatment. Patients who already underwent a glaucoma treatment using SLT or ALT (Argon laser trabeculoplasty) Patients who underwent cataract surgery in the past 3 months. Pregnant patients.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prednisone acetate 1%<br>A topic cortisone-based treatment | Procedure: Selective Laser trabeculoplasty<br>* The Selective Laser Trabeculoplasty is done with the Latina lens after applying a drop of iopidine in the treated eye and alcaïne in both eye. Fifty spots are done over 180°. The maximal and total energy is written in the chart. After the treatment, prednisolone acetate 1% (a corticosteroid), diclofenac 0.1% (an NSAID) or a placebo is used. The three treatments were administered 4 times a day (at breakfast, lunch, dinner and at bedtime) for five days.<br>|
| Active Comparator: diclofenac 0.1%<br>an non-steroidal anti-inflammatory drug | Procedure: Selective Laser trabeculoplasty<br>* The Selective Laser Trabeculoplasty is done with the Latina lens after applying a drop of iopidine in the treated eye and alcaïne in both eye. Fifty spots are done over 180°. The maximal and total energy is written in the chart. After the treatment, prednisolone acetate 1% (a corticosteroid), diclofenac 0.1% (an NSAID) or a placebo is used. The three treatments were administered 4 times a day (at breakfast, lunch, dinner and at bedtime) for five days.<br>|
| Placebo Comparator: Artificial Tears<br>Pharmasciences DIN: 02229570 | Procedure: Selective Laser trabeculoplasty<br>* The Selective Laser Trabeculoplasty is done with the Latina lens after applying a drop of iopidine in the treated eye and alcaïne in both eye. Fifty spots are done over 180°. The maximal and total energy is written in the chart. After the treatment, prednisolone acetate 1% (a corticosteroid), diclofenac 0.1% (an NSAID) or a placebo is used. The three treatments were administered 4 times a day (at breakfast, lunch, dinner and at bedtime) for five days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure in the treated eye |  | 1 hour, 7 days, 1.5, 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects (include a slight uveitis, oculary discomfort and a spike in intraocular pressure in the immediate post-op period) |  | 1 hour, 7 days, 1.5 months, 3 months and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Ocular Hypertension, Intraocular Pressure, Trabeculectomy