Glaucoma, Inflammatory Response
Conditions
Keywords
Glaucoma, Ocular Hypertension, Intraocular Pressure, Trabeculectomy
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).
Interventions
PROCEDURESelective Laser trabeculoplasty
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.
Sponsors
Canadian Glaucoma Clinical Research Council
Pfizer
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure in the treated eye | 1 hour, 7 days, 1.5, 3 and 6 months |
Secondary
| Measure | 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 |
Countries
Canada
Outcome results
None listed