Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion

Glaucoma Clinical Trial

Official title:

Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00551395
• Other study ID #: RC-1
• Status: Terminated
• Phase: Phase 3
• First received: October 29, 2007
• Last updated: September 21, 2015
• Start date: September 2007
• Est. completion date: January 2009

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

This study will evaluate the effect of the timing of treatment completion in two-staged selective laser trabeculoplasty therapy on intraocular pressure lowering effect.

Description:

SLT therapy is used as an IOP lowering agent in patients with glaucoma. It is unknown whether the timing of a 2-staged approach to the laser therapy will result in better IOP lowering effect.

This study will evaluate the timing (early vs. late completion of SLT therapy) and determined the IOP lowering effect following the interventions.

Arm 1: Early Completion SLT

180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees on Day 2

Arm 2: Late Completion SLT

180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees at the 1 month follow up visit.

Primary Outcome: IOP (mmHg).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age

• primary open angle glaucoma or pseudoexfoliation glaucoma

Exclusion Criteria:

• Unable to give informed consent

Study Design

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• selective laser trabeculoplasty - early completion
180 degrees of laser on day 1 and other 180 degrees on day 2.
• Selective laser trabeculoplasty - late completion
180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point.

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital & Queen's University	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraocular pressure lowering		1 month following procedure	Yes
Secondary	intraocular pressure lowering		3, 6, 12 and 24 months following procedure	Yes