Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

Overview

The type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will evaluate the IOP lowering effect of SLT following the topical administration of one of the following: prednisolone 1%, ketorolac 0.5% or artificial tears.

Full Title of Study: “Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2009

Detailed Description

Patients who have been chosen to undergo SLT for glaucoma will be randomized to receive one of prednisolone 1%, ketorolac 0.5% or artificial tears four times a day for 5 days following administration of the laser treatment. The IOP will be measured at various time points following SLT: 1 hour, 2 days, 1 week, 1 month, 3 months, 6 months, and 1 year.

Interventions

  • Drug: prednisolone 1%
    • eye drop once in each eye treated, 4 times / day for 5 days post-laser
  • Drug: ketorolac 0.5%
    • eye drop once in each eye treated, 4 times / day for 5 days post-laser
  • Drug: Artificial Tears (Methyl cellulose drops)
    • eye drop once in each eye treated, 4 times / day for 5 days post-laser

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Prednisolone 1% eye drop
  • Active Comparator: 2
    • ketorolac 0.5% eye drop
  • Placebo Comparator: 3
    • Artificial Tears (methyl cellulose eye drop)

Clinical Trial Outcome Measures

Primary Measures

  • Intraocular pressure lowering effect
    • Time Frame: 1 hour, 2 days, 1 month, 3 months, 6 months and 1 year

Secondary Measures

  • intraocular pressure elevation
    • Time Frame: 1 hour, 2 days, 1 month

Participating in This Clinical Trial

Inclusion Criteria

  • primary open angle glaucoma, pseudo exfoliation glaucoma Exclusion Criteria:

  • previous incisional glaucoma surgery

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Queen’s University
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Robert Campbell, Assistant Professor – Queen’s University
  • Overall Official(s)
    • Rob J Campbell, MD, MSc, Principal Investigator, Queen’s University
    • Delan Jinapriya, MD, Study Director, Queen’s University

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