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Response to SLT vs. ALT in Patients Under 60 Years of Age

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Completed
CT.gov ID
NCT01087684
Collaborator
(none)
42
Enrollment
1
Location
2
Arms
48
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Argon laser trabeculoplasty
  • Procedure: Selective laser trabeculoplasty
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2004
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Dec 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Argon laser trabeculoplasty

Patients received standard argon laser treatment

Procedure: Argon laser trabeculoplasty
Argon laser 600-800 mW, 0.1seconds, 50 micron spot size, 45 - 55 burns over 180 degrees of trabecular meshwork
Other Names:
  • ALT

    		•
    Active Comparator: Selective laser trabeculoplasty

    Patients received a standard selective laser treatment

    Procedure: Selective laser trabeculoplasty
    Selective laser trabeculoplasty 0.7 - 0.8 mJ, 400 micron spot size, 3 nanosecond, 45 - 55 burns over 180 degrees of trabecular meshwork.
    Other Names:
  • SLT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular pressure [Two years]

      The intraocular pressure was measured at 6 weeks, 4.5 months, 9, 12, 18 and 24 months following the laser treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age < 60 years

    • Intraocular pressure not adequately controlled

    Exclusion Criteria:
    • Prior laser treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

    Sponsors and Collaborators

    • Sunnybrook Health Sciences Centre

    Investigators

    • Principal Investigator: Catherine M Birt, MD, Sunnybrook Health Sciences Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Catherine Birt, MD, Sunnybrook Health Sciences Centre
    ClinicalTrials.gov Identifier:
    NCT01087684
    Other Study ID Numbers:
    • 459-2004
    First Posted:
    Mar 16, 2010
    Last Update Posted:
    Oct 10, 2013
    Last Verified:
    Oct 1, 2013
    Keywords provided by Dr. Catherine Birt, MD, Sunnybrook Health Sciences Centre
    Glaucoma
    laser trabeculoplasty
    intraocular pressure
    Additional relevant MeSH terms:
    Glaucoma

    Study Results

    No Results Posted as of Oct 10, 2013