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Clinical Trials/NCT01058278
NCT01058278
Completed
N/A

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

CHU de Quebec-Universite Laval1 site in 1 country67 target enrollmentMarch 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Glaucoma
Sponsor
CHU de Quebec-Universite Laval
Enrollment
67
Locations
1
Primary Endpoint
Intraocular pressure in the treated eye
Status
Completed
Last Updated
10 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
CHU de Quebec-Universite Laval
Responsible Party
Principal Investigator
Principal Investigator

Béatrice Des Marchais

Chercheure clinicienne associée

CHU de Quebec-Universite Laval

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.

Outcomes

Primary Outcomes

Intraocular pressure in the treated eye

Time Frame: 1 hour, 7 days, 1.5, 3 and 6 months

Secondary Outcomes

  • 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 Sites (1)

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