Clinical trial NCT01687465: A Trial to Compare the Laser Treatment (SLT vs. ALT) in Glaucoma Patients
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glaucoma
Keywords: glaucoma
laser
SLT
ALT
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Intraocular Pressure
timeFrame: 12 months post operatively
Secondary outcomes:
measure: To compare the IOP lowering effect between the groups at other postoperative visits
timeFrame: 12 months
measure: To compare the visual acuity between the groups at all visits.
timeFrame: 12 months
measure: To compare the trabecular meshwork pigmentation between the groups at all visits.
timeFrame: 12 months
measure: To compare any adverse events between the two groups at all visits.
timeFrame: 12 months
measure: SLT repeatability of long term follow up in glaucoma patients
timeFrame: 36 months after initial enrollment of the primary study
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Rockyview General Hospital, University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital, University of Alberta
state: Alberta
city: Halifax
country: Canada
facility: Eye Care Centre, Dalhousie University
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaser University, St. Joseph's Healthcare Hamilton, CAHS Regional Eye Institute
state: Ontario
city: London
country: Canada
facility: Ivey Eye Institute, St. Joseph's Hospital, Western University
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, University of Toronto
state: Ontario
city: Montreal
country: Canada
facility: McGill University, Dept. of Ophthalmology, Royal Victoria Hospital,
state: Quebec
Study officials:
affiliation: Lawson Research Institute, Univ. of Western Ontario
name: William G Hodge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.