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

Laval University

Status: Completed

Conditions: Glaucoma; Inflammatory Response

Treatments: Procedure: Selective Laser trabeculoplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01058278

DR-002-1213

Details and patient eligibility

About

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.

Full 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).

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 3 patient groups, including a placebo group

Prednisone acetate 1%

Active Comparator group

Description:

A topic cortisone-based treatment

Treatment:

Procedure: Selective Laser trabeculoplasty

diclofenac 0.1%

Active Comparator group

Description:

an non-steroidal anti-inflammatory drug

Treatment:

Procedure: Selective Laser trabeculoplasty

Artificial Tears

Placebo Comparator group

Description:

Pharmasciences DIN: 02229570

Treatment:

Procedure: Selective Laser trabeculoplasty