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

Phase 3

• Conditions: Glaucoma
• Interventions: Procedure: Argon laser trabeculoplasty; Procedure: Selective laser trabeculoplasty

• Registration Number: NCT01687465
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-19
• Study Start: 2012-11
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
selective laser trabeculoplasty	Argon laser trabeculoplasty	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.
Argon laser trabeculoplasty	Selective laser trabeculoplasty	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.
selective laser trabeculoplasty	Selective laser trabeculoplasty	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.
Argon laser trabeculoplasty	Argon laser trabeculoplasty	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.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure	12 months post operatively	IOP difference between baseline and 12 month post-laser.

Secondary Outcome Measures

Name	Time	Method
To compare any adverse events between the two groups at all visits.	12 months
To compare the trabecular meshwork pigmentation between the groups at all visits.	12 months
To compare the IOP lowering effect between the groups at other postoperative visits	12 months	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.	12 months	VA difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.
SLT repeatability of long term follow up in glaucoma patients	36 months after initial enrollment of the primary study	The follow up time has been extended two more years. Patients will be followed up Q6 months.

Trial Locations

Locations (7)

McMaser University, St. Joseph's Healthcare Hamilton, CAHS Regional Eye Institute; 🇨🇦 Hamilton, Ontario, Canada

Ivey Eye Institute, St. Joseph's Hospital, Western University; 🇨🇦 London, Ontario, Canada

Sunnybrook Health Sciences Centre, University of Toronto; 🇨🇦 Toronto, Ontario, Canada

Rockyview General Hospital, University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Eye Care Centre, Dalhousie University; 🇨🇦 Halifax, Nova Scotia, Canada

Royal Alexandra Hospital, University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

McGill University, Dept. of Ophthalmology, Royal Victoria Hospital,; 🇨🇦 Montreal, Quebec, Canada