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

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

Tracking Information

• First Submitted Date: March 15, 2010
• First Posted Date: March 16, 2010
• Last Update Posted Date: October 10, 2013
• Study Start Date: December 2004
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: March 15, 2010): Intraocular pressure [ Time Frame: Two years ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Glaucoma

Intervention

• 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

• 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.

Recruitment Information

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

Eligibility Criteria

Inclusion Criteria:

• Age < 60 years
• Intraocular pressure not adequately controlled

Exclusion Criteria:

• Prior laser treatment

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01087684
• Other Study ID Numbers: 459-2004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Catherine Birt, Sunnybrook Health Sciences Centre
• Study Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Not Provided

Investigators

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

• PRS Account: Sunnybrook Health Sciences Centre
• Verification Date: October 2013