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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Glaucoma Clinical Research Council
Pfizer
Information provided by (Responsible Party):
Béatrice Des Marchais, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01058278
First received: January 27, 2010
Last updated: July 25, 2014
Last verified: December 2013

January 27, 2010
July 25, 2014
March 2008
June 2012   (final data collection date for primary outcome measure)
Intraocular pressure in the treated eye [ Time Frame: 1 hour, 7 days, 1.5, 3 and 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01058278 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma
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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Glaucoma
  • Inflammatory Response
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: Prednisone acetate 1%
    A topic cortisone-based treatment
    Intervention: Procedure: Selective Laser trabeculoplasty
  • Active Comparator: diclofenac 0.1%
    an non-steroidal anti-inflammatory drug
    Intervention: Procedure: Selective Laser trabeculoplasty
  • Placebo Comparator: Artificial Tears
    Pharmasciences DIN: 02229570
    Intervention: Procedure: Selective Laser trabeculoplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
138
December 2014
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01058278
DR-002-1213
No
Béatrice Des Marchais, Centre Hospitalier Universitaire de Québec, CHU de Québec
Centre Hospitalier Universitaire de Québec, CHU de Québec
  • Canadian Glaucoma Clinical Research Council
  • Pfizer
Principal Investigator: Béatrice Des Marchais, FRCSC M.Sc. Centre Hospitalier Universitaire de Québec, CHU de Québec
Centre Hospitalier Universitaire de Québec, CHU de Québec
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP