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

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ClinicalTrials.gov Identifier: NCT01087684
Recruitment Status : Completed
First Posted : March 16, 2010
Last Update Posted : October 10, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Catherine Birt, Sunnybrook Health Sciences Centre

Tracking Information
First Submitted Date  ICMJE March 15, 2010
First Posted Date  ICMJE March 16, 2010
Last Update Posted Date October 10, 2013
Study Start Date  ICMJE December 2004
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2010)
Intraocular pressure [ Time Frame: Two years ]
The intraocular pressure was measured at 6 weeks, 4.5 months, 9, 12, 18 and 24 months following the laser treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2010)
Intraocular pressure [ Time Frame: Two years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Response to SLT vs. ALT in Patients Under 60 Years of Age
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • 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 Name: ALT
  • 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 Name: SLT
Study Arms  ICMJE
  • Active Comparator: Argon laser trabeculoplasty
    Patients received standard argon laser treatment
    Intervention: Procedure: Argon laser trabeculoplasty
  • Active Comparator: Selective laser trabeculoplasty
    Patients received a standard selective laser treatment
    Intervention: Procedure: Selective laser trabeculoplasty
Publications * 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.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2010)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age < 60 years
  • Intraocular pressure not adequately controlled

Exclusion Criteria:

  • Prior laser treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (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 NCT01087684
Other Study ID Numbers  ICMJE 459-2004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Catherine Birt, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine M Birt, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date October 2013

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