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

NCT01058278 | Completed

• 1 other identifier: DR-002-1213
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma; Inflammatory Response

Keywords

Glaucoma; Ocular Hypertension; Intraocular Pressure; Trabeculectomy

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure in the treated eye

  1 hour, 7 days, 1.5, 3 and 6 months

Secondary Outcomes (1)

• 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

Study Arms (3)

Prednisone acetate 1%

ACTIVE COMPARATOR

A topic cortisone-based treatment

Procedure: Selective Laser trabeculoplasty

diclofenac 0.1%

ACTIVE COMPARATOR

an non-steroidal anti-inflammatory drug

Procedure: Selective Laser trabeculoplasty

Artificial Tears

PLACEBO COMPARATOR

Pharmasciences DIN: 02229570

Procedure: Selective Laser trabeculoplasty

Interventions

Selective Laser trabeculoplasty 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; Prednisone acetate 1%; diclofenac 0.1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Glaucoma Clinical Research Council: collaborator
• Pfizer: collaborator

Study Sites (1)

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

Québec, Quebec, G1S 4L8, Canada

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Béatrice Des Marchais, FRCSC M.Sc.

  CHU de Quebec-Universite Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chercheure clinicienne associée

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: March 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2015
• Last Updated: February 29, 2016

Record last verified: 2016-02

Locations

CA (1)