Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

Primary Open Angle Glaucoma Clinical Trial

Official title:

Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485108
• Other study ID #: DJ1
• Status: Completed
• Phase: N/A
• First received: June 9, 2007
• Last updated: September 21, 2015
• Start date: January 2007
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion Criteria:

• previous incisional glaucoma surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exfoliation Syndrome
• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma
• Pseudoexfoliation Glaucoma

Intervention

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

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University	Glaucoma Research Society of Canada, Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure lowering effect		1 hour, 2 days, 1 month, 3 months, 6 months and 1 year	No
Secondary	intraocular pressure elevation		1 hour, 2 days, 1 month	Yes