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

Primary Purpose

Glaucoma, Inflammatory Response

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Selective Laser trabeculoplasty
Sponsored by
CHU de Quebec-Universite Laval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Ocular Hypertension, Intraocular Pressure, Trabeculectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Prednisone acetate 1%

diclofenac 0.1%

Artificial Tears

Arm Description

A topic cortisone-based treatment

an non-steroidal anti-inflammatory drug

Pharmasciences DIN: 02229570

Outcomes

Primary Outcome Measures

Intraocular pressure in the treated eye

Secondary Outcome Measures

Side effects (include a slight uveitis, oculary discomfort and a spike in intraocular pressure in the immediate post-op period)

Full Information

First Posted
January 27, 2010
Last Updated
February 26, 2016
Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Glaucoma Clinical Research Council, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01058278
Brief Title
Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma
Acronym
SLT
Official Title
Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHU de Quebec-Universite Laval
Collaborators
Canadian Glaucoma Clinical Research Council, Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Inflammatory Response
Keywords
Glaucoma, Ocular Hypertension, Intraocular Pressure, Trabeculectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone acetate 1%
Arm Type
Active Comparator
Arm Description
A topic cortisone-based treatment
Arm Title
diclofenac 0.1%
Arm Type
Active Comparator
Arm Description
an non-steroidal anti-inflammatory drug
Arm Title
Artificial Tears
Arm Type
Placebo Comparator
Arm Description
Pharmasciences DIN: 02229570
Intervention Type
Procedure
Intervention Name(s)
Selective Laser trabeculoplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraocular pressure in the treated eye
Time Frame
1 hour, 7 days, 1.5, 3 and 6 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Béatrice Des Marchais, FRCSC M.Sc.
Organizational Affiliation
CHU de Quebec-Universite Laval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada

12. IPD Sharing Statement

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

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