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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

September 11, 2012
October 9, 2013
November 2012
November 2015   (final data collection date for primary outcome measure)
Intraocular Pressure [ Time Frame: 12 months post operatively ] [ Designated as safety issue: Yes ]
IOP difference between baseline and 12 month post-laser.
Same as current
Complete list of historical versions of study NCT01687465 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Trial to Compare the Laser Treatment (SLT vs. ALT) in Glaucoma Patients
A Randomized Clinical Trial of Selective Laser Trabeculoplasty (SLT) in Open Angle Glaucoma Who Had Been Previously Treated With Complete SLT

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Glaucoma
  • 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: 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.
    Interventions:
    • Procedure: Argon laser trabeculoplasty
    • Procedure: Selective laser trabeculoplasty
  • 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.
    Interventions:
    • Procedure: Argon laser trabeculoplasty
    • Procedure: Selective laser trabeculoplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Canada
 
NCT01687465
CIHR granted glaucoma RCT
Yes
William Hodge, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: William G Hodge, MD, PhD Lawson Research Institute, Western Ontario
Lawson Health Research Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP