Clinical trial NCT01058278: Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma
Official title: Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Inflammatory Response
Keywords: Glaucoma
Ocular Hypertension
Intraocular Pressure
Trabeculectomy
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Glaucoma Clinical Research Council
name: Pfizer
First posted: 2010-01-28
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular pressure in the treated eye
timeFrame: 1 hour, 7 days, 1.5, 3 and 6 months
Secondary outcomes:
measure: Side effects (include a slight uveitis, oculary discomfort and a spike in intraocular pressure in the immediate post-op period)
timeFrame: 1 hour, 7 days, 1.5 months, 3 months and 6 months
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
state: Quebec
Study officials:
affiliation: CHU de Quebec-Universite Laval
name: Béatrice Des Marchais, FRCSC M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: