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

NCT01058278

Last updated date
Study Location
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, Quebec, G1S 4L8, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma, Inflammatory Response
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Glaucoma, Inflammatory ResponseImpact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma
NCT01058278
  1. Québec, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma
Official Title  ICMJE Impact of the Post-operative Treatment on the Intraocular Pressure Post Selective Laser Trabeculoplasty (SLT) on Patients With Primary Open-angle Glaucoma
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma
  • Inflammatory Response
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2016)
67
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2010)
138
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01058278
Other Study ID Numbers  ICMJE DR-002-1213
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Béatrice Des Marchais, CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE
  • Canadian Glaucoma Clinical Research Council
  • Pfizer
Investigators  ICMJE
Principal Investigator:Béatrice Des Marchais, FRCSC M.Sc.CHU de Quebec-Universite Laval
PRS Account CHU de Quebec-Universite Laval
Verification Date February 2016

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