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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
  Purpose

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.


Condition Intervention
Glaucoma
Inflammatory Response
Procedure: Selective Laser trabeculoplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • Intraocular pressure in the treated eye [ Time Frame: 1 hour, 7 days, 1.5, 3 and 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 138
Study Start Date: March 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prednisone acetate 1%
A topic cortisone-based treatment
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: diclofenac 0.1%
an non-steroidal anti-inflammatory drug
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.
Placebo Comparator: Artificial Tears
Pharmasciences DIN: 02229570
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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058278

Locations
Canada, Quebec
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, Quebec, Canada, G1S 4L8
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Canadian Glaucoma Clinical Research Council
Pfizer
Investigators
Principal Investigator: Béatrice Des Marchais, FRCSC M.Sc. Centre Hospitalier Universitaire de Québec, CHU de Québec
  More Information

No publications provided

Responsible Party: Béatrice Des Marchais, Chercheure clinicienne associée, Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier: NCT01058278     History of Changes
Other Study ID Numbers: DR-002-1213
Study First Received: January 27, 2010
Last Updated: July 25, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
Glaucoma
Ocular Hypertension
Intraocular Pressure
Trabeculectomy

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 25, 2014