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

Primary Purpose

Glaucoma

Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
selective laser trabeculoplasty - early completion
Selective laser trabeculoplasty - late completion
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, laser, trabeculoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years of age
  • primary open angle glaucoma or pseudoexfoliation glaucoma

Exclusion Criteria:

  • Unable to give informed consent

Sites / Locations

  • Hotel Dieu Hospital & Queen's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SLT Early Completion (Arm 1)

SLT Late Completion (Arm 2)

Arm Description

Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degree on Day 2

Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degrees at 1 month follow up appointment.

Outcomes

Primary Outcome Measures

intraocular pressure lowering

Secondary Outcome Measures

intraocular pressure lowering

Full Information

First Posted
October 29, 2007
Last Updated
September 21, 2015
Sponsor
Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT00551395
Brief Title
Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion
Official Title
Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
September 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, laser, trabeculoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SLT Early Completion (Arm 1)
Arm Type
Experimental
Arm Description
Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degree on Day 2
Arm Title
SLT Late Completion (Arm 2)
Arm Type
Active Comparator
Arm Description
Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degrees at 1 month follow up appointment.
Intervention Type
Procedure
Intervention Name(s)
selective laser trabeculoplasty - early completion
Intervention Description
180 degrees of laser on day 1 and other 180 degrees on day 2.
Intervention Type
Procedure
Intervention Name(s)
Selective laser trabeculoplasty - late completion
Intervention Description
180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point.
Primary Outcome Measure Information:
Title
intraocular pressure lowering
Time Frame
1 month following procedure
Secondary Outcome Measure Information:
Title
intraocular pressure lowering
Time Frame
3, 6, 12 and 24 months following procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age primary open angle glaucoma or pseudoexfoliation glaucoma Exclusion Criteria: Unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Campbell, MD
Organizational Affiliation
Queen's University, Kingston, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hotel Dieu Hospital & Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
35943114
Citation
Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.
Results Reference
derived

Learn more about this trial

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

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