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

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ClinicalTrials.gov Identifier: NCT01687465
Recruitment Status : Active, not recruiting
First Posted : September 19, 2012
Last Update Posted : March 6, 2018
Sponsor:
Information provided by (Responsible Party):
William Hodge, Lawson Health Research Institute

Tracking Information
First Submitted Date  ICMJE September 11, 2012
First Posted Date  ICMJE September 19, 2012
Last Update Posted Date March 6, 2018
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
Intraocular Pressure [ Time Frame: 12 months post operatively ]
IOP difference between baseline and 12 month post-laser.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01687465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
  • To compare the IOP lowering effect between the groups at other postoperative visits [ Time Frame: 12 months ]
    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 ]
    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 ]
  • To compare any adverse events between the two groups at all visits. [ Time Frame: 12 months ]
  • SLT repeatability of long term follow up in glaucoma patients [ Time Frame: 36 months after initial enrollment of the primary study ]
    The follow up time has been extended two more years. Patients will be followed up Q6 months.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
  • To compare the IOP lowering effect between the groups at other postoperative visits [ Time Frame: 12 months ]
    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 ]
    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 ]
  • To compare any adverse events between the two groups at all visits. [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Compare the Laser Treatment (SLT vs. ALT) in Glaucoma Patients
Official Title  ICMJE A Randomized Clinical Trial of Selective Laser Trabeculoplasty (SLT) in Open Angle Glaucoma Who Had Been Previously Treated With Complete SLT
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 26, 2017)
139
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2012)
144
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01687465
Other Study ID Numbers  ICMJE CIHR granted glaucoma RCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William Hodge, Lawson Health Research Institute
Study Sponsor  ICMJE Lawson Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William G Hodge, MD, PhD Lawson Research Institute, Univ. of Western Ontario
PRS Account Lawson Health Research Institute
Verification Date March 2018

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