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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01087684
• Other study ID #: 459-2004
• Status: Completed
• Phase: N/A
• First received: March 15, 2010
• Last updated: October 8, 2013
• Start date: December 2004
• Est. completion date: December 2008

Study information

• Verified date: October 2013
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age < 60 years

• Intraocular pressure not adequately controlled

Exclusion Criteria:

• Prior laser treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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
• 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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure	The intraocular pressure was measured at 6 weeks, 4.5 months, 9, 12, 18 and 24 months following the laser treatment.	Two years	No