NCT01687465

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
139

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

5.3 years

First QC Date

September 11, 2012

Last Update Submit

March 5, 2018

Conditions

Glaucoma

Keywords

glaucomalaserSLTALT

Outcome Measures

Primary Outcomes (1)

  • Intraocular Pressure

    IOP difference between baseline and 12 month post-laser.

    12 months post operatively

Secondary Outcomes (5)

  • To compare the IOP lowering effect between the groups at other postoperative visits

    12 months

  • To compare the visual acuity between the groups at all visits.

    12 months

  • To compare the trabecular meshwork pigmentation between the groups at all visits.

    12 months

  • To compare any adverse events between the two groups at all visits.

    12 months

  • SLT repeatability of long term follow up in glaucoma patients

    36 months after initial enrollment of the primary study

Study Arms (2)

Argon laser trabeculoplasty

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.

Procedure: Argon laser trabeculoplastyProcedure: Selective laser trabeculoplasty

selective laser trabeculoplasty

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.

Procedure: Argon laser trabeculoplastyProcedure: Selective laser trabeculoplasty

Interventions

Argon laser trabeculoplastyPROCEDURE

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.

Argon laser trabeculoplastyselective laser trabeculoplasty
Selective laser trabeculoplastyPROCEDURE

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.

Argon laser trabeculoplastyselective laser trabeculoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Rockyview General Hospital, University of Calgary

Calgary, Alberta, T3E 7M8, Canada

Location

Royal Alexandra Hospital, University of Alberta

Edmonton, Alberta, T5H 3V9, Canada

Location

Eye Care Centre, Dalhousie University

Halifax, Nova Scotia, B3H2R1, Canada

Location

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

Hamilton, Ontario, L8G 5E4, Canada

Location

Ivey Eye Institute, St. Joseph's Hospital, Western University

London, Ontario, N6A 4V2, Canada

Location

Sunnybrook Health Sciences Centre, University of Toronto

Toronto, Ontario, M4N 3M5, Canada

Location

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

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (2)

  • 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.

    PMID: 35943114DERIVED

  • 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.

    PMID: 30278197DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • William G Hodge, MD, PhD

    Lawson Research Institute, Univ. of Western Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Department of Ophthalmology, Western University

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 19, 2012

Study Start

November 1, 2012

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

CA(7)