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

NCT ID: NCT01058278

Last Updated: 2016-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2015-12-31

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).

Conditions

Glaucoma; Inflammatory Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Prednisone acetate 1%

A topic cortisone-based treatment

Group Type: ACTIVE_COMPARATOR

Selective Laser trabeculoplasty

Intervention Type: PROCEDURE

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.

diclofenac 0.1%

an non-steroidal anti-inflammatory drug

Group Type: ACTIVE_COMPARATOR

Selective Laser trabeculoplasty

Intervention Type: PROCEDURE

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.

Artificial Tears

Pharmasciences DIN: 02229570

Group Type: PLACEBO_COMPARATOR

Selective Laser trabeculoplasty

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Glaucoma Clinical Research Council

OTHER

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Béatrice Des Marchais

Chercheure clinicienne associée

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Béatrice Des Marchais, FRCSC M.Sc.

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec-Universite Laval

Locations

Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

DR-002-1213

Identifier Type: -

Identifier Source: org_study_id