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

NCT ID: NCT01687465

Last Updated: 2018-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2018-03-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Argon laser trabeculoplasty

Intervention Type: PROCEDURE

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.

Selective laser trabeculoplasty

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Argon laser trabeculoplasty

Intervention Type: PROCEDURE

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.

Selective laser trabeculoplasty

Intervention Type: PROCEDURE

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.

Interventions

Argon laser trabeculoplasty

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

Selective laser trabeculoplasty

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

William Hodge

Professor of Department of Ophthalmology, Western University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William G Hodge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lawson Research Institute, Univ. of Western Ontario

Locations

Rockyview General Hospital, University of Calgary

Calgary, Alberta, Canada

Royal Alexandra Hospital, University of Alberta

Edmonton, Alberta, Canada

Eye Care Centre, Dalhousie University

Halifax, Nova Scotia, Canada

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

McGill University, Dept. of Ophthalmology, Royal Victoria Hospital,

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 35943114 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30278197 (View on PubMed)

Other Identifiers

CIHR granted glaucoma RCT

Identifier Type: -

Identifier Source: org_study_id