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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

Study Description
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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
Glaucoma Procedure: Argon laser trabeculoplasty Procedure: Selective laser trabeculoplasty Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : December 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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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 Name: 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 Name: SLT


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age < 60 years
  • Intraocular pressure not adequately controlled

Exclusion Criteria:

  • Prior laser treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087684


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Catherine M Birt, MD Sunnybrook Health Sciences Centre
More Information
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Publications of Results:

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Responsible Party: Dr. Catherine Birt, MD, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01087684    
Other Study ID Numbers: 459-2004
First Posted: March 16, 2010    Key Record Dates
Last Update Posted: October 10, 2013
Last Verified: October 2013
Keywords provided by Dr. Catherine Birt, Sunnybrook Health Sciences Centre:
Glaucoma
laser trabeculoplasty
intraocular pressure
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases