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

Not Applicable

Completed

• Conditions: Glaucoma; Inflammatory Response
• Interventions: Procedure: Selective Laser trabeculoplasty

• Registration Number: NCT01058278
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief Summary

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

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).

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Primary Completion: 2012-06
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone acetate 1%	Selective Laser trabeculoplasty	A topic cortisone-based treatment
diclofenac 0.1%	Selective Laser trabeculoplasty	an non-steroidal anti-inflammatory drug
Artificial Tears	Selective Laser trabeculoplasty	Pharmasciences DIN: 02229570

Primary Outcome Measures

Name	Time	Method
Intraocular pressure in the treated eye	1 hour, 7 days, 1.5, 3 and 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec; 🇨🇦 Québec, Quebec, Canada