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CompletedNCT01058278SLTUpdated Feb 29, 2016

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

An interventional study of Selective Laser trabeculoplasty in Glaucoma and Inflammatory Response, sponsored by CHU de Quebec-Universite Laval. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-29.

Sponsored by CHU de Quebec-Universite Laval · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Glaucoma
  • Inflammatory Response

Keywords

  • Glaucoma
  • Ocular Hypertension
  • Intraocular Pressure
  • Trabeculectomy
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 67 is close to the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

CHU de Quebec-Universite Laval is the lead sponsor of 134 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
67 participants (actual)

Study arms

  • Active comparator
    Prednisone acetate 1%

    A topic cortisone-based treatment

    Procedure: Selective Laser trabeculoplasty

  • 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

Interventions

  • ProcedureSelective 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.

06

What researchers measure

Primary outcomes

  1. Intraocular pressure in the treated eye

    Time frame: 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)

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

07

Study locations

1 site
  • Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
    Québec, Quebec G1S 4L8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01058278
Lead sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Glaucoma Clinical Research Council, Pfizer
Responsible party
Béatrice Des Marchais (Chercheure clinicienne associée, CHU de Quebec-Universite Laval) — Principal investigator
First posted
Jan 28, 2010
Start date
Mar 2008
Primary completion
Jun 2012
Completion
Dec 2015
Last update
Feb 29, 2016

Study contacts

Béatrice Des Marchais, FRCSC M.Sc.
principal investigator · CHU de Quebec-Universite Laval

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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