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A Trial to Compare the Laser Treatment (SLT vs. ALT) in Glaucoma Patients (SLTRepeat)

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Argon laser trabeculoplasty
Selective laser trabeculoplasty
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Over age of 18 yo.
  • OAG including pigmentary dispersion syndrome and pseudoexfoliation
  • OAG has been treated with 360 degrees of SLT
  • two sighted eyes,
  • willing to participate after being informed of and reading the patient information material.

Exclusion Criteria:

  • Narrow angle glaucoma
  • Previous glaucoma surgery
  • Eye surgery expected in the next 12 months
  • Severe corneal disease
  • On or anticipated steroid in 6 months
  • Pregnant or breast feeding

Sites / Locations

  • Rockyview General Hospital, University of Calgary
  • Royal Alexandra Hospital, University of Alberta
  • Eye Care Centre, Dalhousie University
  • McMaser University, St. Joseph's Healthcare Hamilton, CAHS Regional Eye Institute
  • Ivey Eye Institute, St. Joseph's Hospital, Western University
  • Sunnybrook Health Sciences Centre, University of Toronto
  • McGill University, Dept. of Ophthalmology, Royal Victoria Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Argon laser trabeculoplasty

selective laser trabeculoplasty

Arm Description

Up to the year 2005, the vast majority of ophthalmologists used Argon laser trabeculoplasty (ALT) as the mode of laser therapy. ALT is effective but its most significant problem is that its effectiveness decreases with re-treatment since the tissue it targets (the trabecular meshwork) is changed by the laser rendering repeat treatments less effective.

Post 2005, a newer mode of laser therapy, selective laser trabeculoplasty (SLT) has emerged as the standard of care laser. There are many potential advantages to SLT but to date these advantages are only theoretical. The most important potential clinical advantage of SLT is that it causes less damage to the tissue it targets.

Outcomes

Primary Outcome Measures

Intraocular Pressure
IOP difference between baseline and 12 month post-laser.

Secondary Outcome Measures

To compare the IOP lowering effect between the groups at other postoperative visits
IOP difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.
To compare the visual acuity between the groups at all visits.
VA difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.
To compare the trabecular meshwork pigmentation between the groups at all visits.
To compare any adverse events between the two groups at all visits.
SLT repeatability of long term follow up in glaucoma patients
The follow up time has been extended two more years. Patients will be followed up Q6 months.

Full Information

First Posted
September 11, 2012
Last Updated
March 5, 2018
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01687465
Brief Title
A Trial to Compare the Laser Treatment (SLT vs. ALT) in Glaucoma Patients
Acronym
SLTRepeat
Official Title
A Randomized Clinical Trial of Selective Laser Trabeculoplasty (SLT) in Open Angle Glaucoma Who Had Been Previously Treated With Complete SLT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Lasers are important therapy in glaucoma. They are a pivotal point in treatment between medical and surgical care. Over the last 10 years a new laser has emerged as the usual laser treatment: Selective laser trabeculoplasty (SLT). SLT works as well as the older laser used: argon laser trabeculoplasty (ALT). However SLT has many theoretical benefits over ALT including causing less damage to the tissue it affects. One of the potential patient centered benefits of this laser is that it may be repeatable. It is even possible that the old laser ALT may be useable after an SLT treatment. This study aims to uncover whether repeat laser is possible after SLT and if so which laser is more effective (ALT vs SLT). The potential of repeating laser therapies may delay surgical treatment and its complications. Also understanding which laser to use will help eye doctors know how to treat their patients at this point of the disease.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Argon laser trabeculoplasty
Arm Type
Active Comparator
Arm Description
Up to the year 2005, the vast majority of ophthalmologists used Argon laser trabeculoplasty (ALT) as the mode of laser therapy. ALT is effective but its most significant problem is that its effectiveness decreases with re-treatment since the tissue it targets (the trabecular meshwork) is changed by the laser rendering repeat treatments less effective.
Arm Title
selective laser trabeculoplasty
Arm Type
Active Comparator
Arm Description
Post 2005, a newer mode of laser therapy, selective laser trabeculoplasty (SLT) has emerged as the standard of care laser. There are many potential advantages to SLT but to date these advantages are only theoretical. The most important potential clinical advantage of SLT is that it causes less damage to the tissue it targets.
Intervention Type
Procedure
Intervention Name(s)
Argon laser trabeculoplasty
Intervention Description
With Argon laser trabeculoplasty (ALT), thermal energy is used directed towards the Trabecular Meshwork (the site of aqueous drainage from the eye),which causes focal scarring of trabecular meshwork, thus enable fluid drainage more effectively. However, this procedure may not be repeatable since it causes too much damage to the trabecular meshwork.
Intervention Type
Procedure
Intervention Name(s)
Selective laser trabeculoplasty
Intervention Description
Selective laser trabeculoplasty is a relatively newer technology that uses a Nd:YAG laser to target specific cells within the trabecular meshwork. SLT does not cause coagulative damage to the trabecular meshwork, and thus has the advantage of being repeatable.
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
IOP difference between baseline and 12 month post-laser.
Time Frame
12 months post operatively
Secondary Outcome Measure Information:
Title
To compare the IOP lowering effect between the groups at other postoperative visits
Description
IOP difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.
Time Frame
12 months
Title
To compare the visual acuity between the groups at all visits.
Description
VA difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.
Time Frame
12 months
Title
To compare the trabecular meshwork pigmentation between the groups at all visits.
Time Frame
12 months
Title
To compare any adverse events between the two groups at all visits.
Time Frame
12 months
Title
SLT repeatability of long term follow up in glaucoma patients
Description
The follow up time has been extended two more years. Patients will be followed up Q6 months.
Time Frame
36 months after initial enrollment of the primary study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over age of 18 yo. OAG including pigmentary dispersion syndrome and pseudoexfoliation OAG has been treated with 360 degrees of SLT two sighted eyes, willing to participate after being informed of and reading the patient information material. Exclusion Criteria: Narrow angle glaucoma Previous glaucoma surgery Eye surgery expected in the next 12 months Severe corneal disease On or anticipated steroid in 6 months Pregnant or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William G Hodge, MD, PhD
Organizational Affiliation
Lawson Research Institute, Univ. of Western Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rockyview General Hospital, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E 7M8
Country
Canada
Facility Name
Royal Alexandra Hospital, University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Eye Care Centre, Dalhousie University
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2R1
Country
Canada
Facility Name
McMaser University, St. Joseph's Healthcare Hamilton, CAHS Regional Eye Institute
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8G 5E4
Country
Canada
Facility Name
Ivey Eye Institute, St. Joseph's Hospital, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre, University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
McGill University, Dept. of Ophthalmology, Royal Victoria Hospital,
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
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
PubMed Identifier
30278197
Citation
Hutnik C, Crichton A, Ford B, Nicolela M, Shuba L, Birt C, Sogbesan E, Damji KF, Dorey M, Saheb H, Klar N, Guo H, Hodge W. Selective Laser Trabeculoplasty versus Argon Laser Trabeculoplasty in Glaucoma Patients Treated Previously with 360 degrees Selective Laser Trabeculoplasty: A Randomized, Single-Blind, Equivalence Clinical Trial. Ophthalmology. 2019 Feb;126(2):223-232. doi: 10.1016/j.ophtha.2018.09.037. Epub 2018 Sep 29.
Results Reference
derived

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A Trial to Compare the Laser Treatment (SLT vs. ALT) in Glaucoma Patients

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