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

Sponsor

CHU de Quebec-Universite Laval (Other)

Overall Status

Completed

CT.gov ID

NCT01058278

Collaborator

Canadian Glaucoma Clinical Research Council (Other), Pfizer (Industry)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Inflammatory Response	Procedure: Selective Laser trabeculoplasty	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prednisone acetate 1% A topic cortisone-based treatment	Procedure: Selective 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.
Active Comparator: diclofenac 0.1% an non-steroidal anti-inflammatory drug	Procedure: Selective 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.
Placebo Comparator: Artificial Tears Pharmasciences DIN: 02229570	Procedure: Selective 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.

Arm

Intervention/Treatment

Active Comparator: Prednisone acetate 1%

A topic cortisone-based treatment

Procedure: Selective 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.

Active Comparator: diclofenac 0.1%

an non-steroidal anti-inflammatory drug

Procedure: Selective Laser trabeculoplasty

Placebo Comparator: Artificial Tears

Pharmasciences DIN: 02229570

Procedure: Selective Laser trabeculoplasty

Outcome Measures

Primary Outcome Measures

Intraocular pressure in the treated eye [1 hour, 7 days, 1.5, 3 and 6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.