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SLTRepeatA Randomized Clinical Trial of Selective Laser Trabeculoplasty (SLT) in Open Angle Glaucoma Who Had Been Previously Treated With Complete SLT

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What is being tested

Argon laser trabeculoplasty

+ Selective laser trabeculoplasty

+ Argon laser trabeculoplasty

Procedure
Who is being recruted

Eye Diseases

+ Ocular Hypertension

+ Glaucoma

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Last updated: March 6, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01687465
Principal SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Last updated: March 6, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

139 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesOcular HypertensionGlaucoma

Criteria

5 inclusion criteria required to participate
OAG has been treated with 360 degrees of SLT
OAG including pigmentary dispersion syndrome and pseudoexfoliation
Over age of 18 yo
two sighted eyes
Show More Criteria
6 exclusion criteria prevent from participating
Eye surgery expected in the next 12 months
Narrow angle glaucoma
On or anticipated steroid in 6 months
Pregnant or breast feeding
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Rockyview General Hospital, University of Calgary

Calgary, CanadaOpen Rockyview General Hospital, University of Calgary in Google Maps

Royal Alexandra Hospital, University of Alberta

Edmonton, Canada

Eye Care Centre, Dalhousie University

Halifax, Canada

McMaser University, St. Joseph's Healthcare Hamilton, CAHS Regional Eye Institute

Hamilton, Canada
Suspended7 Study Centers