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

Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Inflammatory Response
• Intervention / Treatment: Procedure: Selective Laser trabeculoplasty

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Québec, Quebec, Canada, G1S 4L8
      • Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraocular pressure in the treated eye	1 hour, 7 days, 1.5, 3 and 6 months

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: Pfizer; Canadian Glaucoma Clinical Research Council
• Investigators: Principal Investigator: Béatrice Des Marchais, FRCSC M.Sc., CHU de Quebec-Universite Laval

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 27, 2010
• First Submitted That Met QC Criteria: January 27, 2010
• First Posted (Estimate): January 28, 2010

Study Record Updates

• Last Update Posted (Estimate): February 29, 2016
• Last Update Submitted That Met QC Criteria: February 26, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Intraocular Pressure; Ocular Hypertension; Glaucoma; Trabeculectomy
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: DR-002-1213