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

Glaucoma Clinical Trial

— SLTRepeat  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01687465
• Other study ID #: CIHR granted glaucoma RCT
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 11, 2012
• Last updated: March 5, 2018
• Start date: November 2012
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 139
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	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	McGill University, Dept. of Ophthalmology, Royal Victoria Hospital,	Montreal	Quebec
Canada	Sunnybrook Health Sciences Centre, University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	IOP difference between baseline and 12 month post-laser.	12 months post operatively
Secondary	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.	12 months
Secondary	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.	12 months
Secondary	To compare the trabecular meshwork pigmentation between the groups at all visits.		12 months
Secondary	To compare any adverse events between the two groups at all visits.		12 months
Secondary	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.	36 months after initial enrollment of the primary study