Back to resultsResponse to SLT vs. ALT in Patients Under 60 Years of Age
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Argon laser trabeculoplasty
Selective laser trabeculoplasty
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, laser trabeculoplasty, intraocular pressure
Eligibility Criteria
Inclusion Criteria:
- Age < 60 years
- Intraocular pressure not adequately controlled
Exclusion Criteria:
- Prior laser treatment
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Argon laser trabeculoplasty
Selective laser trabeculoplasty
Arm Description
Patients received standard argon laser treatment
Patients received a standard selective laser treatment
Outcomes
Primary Outcome Measures
Intraocular pressure
The intraocular pressure was measured at 6 weeks, 4.5 months, 9, 12, 18 and 24 months following the laser treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT01087684
First Posted
March 15, 2010
Last Updated
October 8, 2013
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01087684
Brief Title
Response to SLT vs. ALT in Patients Under 60 Years of Age
Official Title
A Prospective, Randomized, Clinically Based Study on the Response to Selective Laser Trabeculoplasty Versus Argon Laser Trabeculoplasty in Patients Who Are Under 60 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Laser trabeculoplasty is a routine treatment for glaucoma and can be performed with either argon (ALT) or selective Yag (SLT) lasers. The effectiveness of each has not been studied in patients under 60 years, which is younger than average for the procedure. The study hypothesis is that there will be no difference between the two laser types.
Detailed Description
Forty-two young patients (age 29 to 60) had one eye randomized to ALT (n = 22) or SLT (n = 20). Intraocular pressure was measured prior to laser and 1 hour, 1 day, 6 weeks, 3 months, every 3 months until 2 years, and then yearly post-laser. χ2 analysis and student's t-test were used to determine statistical significance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, laser trabeculoplasty, intraocular pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Argon laser trabeculoplasty
Arm Type
Active Comparator
Arm Description
Patients received standard argon laser treatment
Arm Title
Selective laser trabeculoplasty
Arm Type
Active Comparator
Arm Description
Patients received a standard selective laser treatment
Intervention Type
Procedure
Intervention Name(s)
Argon laser trabeculoplasty
Other Intervention Name(s)
ALT
Intervention Description
Argon laser 600-800 mW, 0.1seconds, 50 micron spot size, 45 - 55 burns over 180 degrees of trabecular meshwork
Intervention Type
Procedure
Intervention Name(s)
Selective laser trabeculoplasty
Other Intervention Name(s)
SLT
Intervention Description
Selective laser trabeculoplasty 0.7 - 0.8 mJ, 400 micron spot size, 3 nanosecond, 45 - 55 burns over 180 degrees of trabecular meshwork.
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
The intraocular pressure was measured at 6 weeks, 4.5 months, 9, 12, 18 and 24 months following the laser treatment.
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age < 60 years
Intraocular pressure not adequately controlled
Exclusion Criteria:
Prior laser treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine M Birt, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21572334
Citation
Liu Y, Birt CM. Argon versus selective laser trabeculoplasty in younger patients: 2-year results. J Glaucoma. 2012 Feb;21(2):112-5. doi: 10.1097/IJG.0b013e318202791c.
Results Reference
result
Learn more about this trial
Response to SLT vs. ALT in Patients Under 60 Years of Age
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