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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
William Hodge, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01687465
First received: September 11, 2012
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Glaucoma
Procedure: Argon laser trabeculoplasty
Procedure: Selective laser trabeculoplasty
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Selective Laser Trabeculoplasty (SLT) in Open Angle Glaucoma Who Had Been Previously Treated With Complete SLT

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: 12 months post operatively ] [ Designated as safety issue: Yes ]
    IOP difference between baseline and 12 month post-laser.


Secondary Outcome Measures:
  • To compare the IOP lowering effect between the groups at other postoperative visits [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    VA difference between baseline, 1hr, 1 wk, and 1, 3, 6 and 12 mon post-laser.

  • To compare the trabecular meshwork pigmentation between the groups at all visits. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To compare any adverse events between the two groups at all visits. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 144
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
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.
Active Comparator: 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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687465

Contacts
Contact: William Hodge, MD, PhD 519-6466000 ext 6121- .hodge@sjhc.london.on.ca
Contact: Francie Si, MD 519-6466000 ext 66244 francie.si@lhsc.on.cawilliam

Locations
Canada, Alberta
Rockyview General Hospital, University of Calgary Recruiting
Calgary, Alberta, Canada, T3E 7M8
Contact: Andrew Crichton, MD, FRCSC    403- 245-3730    drcricht@telusplanet.net   
Contact: Jaspreet Grewal, BSc, COMT    +1.403.245.0978    <jaspreetg@gmail.com>   
Principal Investigator: Andrew Crichton, MD, FRCSC         
Royal Alexandra Hospital, University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Karim Damji, MD, FRCSC    780- 735-4200    kdamji@ualberta.ca   
Contact: Sourabh Arora, BSc., MD    780 735 1111 ext 12447    <sourabh@ualberta.ca>   
Principal Investigator: Karim Damji, MD, FRCSC         
Canada, Nova Scotia
Eye Care Centre, Dalhousie University Recruiting
Halifax, Nova Scotia, Canada, B3H2R1
Contact: Marcelo Nicolela, MD, FRCSC    902- 473-3622    nicolela@dal.ca   
Contact: Neasa Bheilbigh, B.A.    902-473-3236    neasabheilbigh@gmail.com   
Principal Investigator: Marcelo Nicolela, MD, FRCSC         
Canada, Ontario
Ivey Eye Institute, St. Joseph's Hospital, Western University Recruiting
London, Ontario, Canada, N6A 4V2
Sub-Investigator: Cindy Hutnik, MD, FRCSC         
Principal Investigator: William Hodge, MD, FRCSC         
Sunnybrook Health Sciences Centre, University of Toronto Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Catherine Birt, MD, FRCSC    416-480-5882    catherine.birt@sunnybrook.ca   
Contact: Charlene Muller, RN, PHN,CCRP    416-480-5091    Charlene.Muller@sunnybrook.ca   
Principal Investigator: Catherine Birt, MD, FRCSC         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: William G Hodge, MD, PhD Lawson Research Institute, Western Ontario
  More Information

No publications provided

Responsible Party: William Hodge, Chair and Professor of Department of Ophthalmology, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01687465     History of Changes
Other Study ID Numbers: CIHR granted glaucoma RCT
Study First Received: September 11, 2012
Last Updated: October 9, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Lawson Health Research Institute:
glaucoma
laser
SLT
ALT

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014