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

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Argon laser trabeculoplasty
Selective laser trabeculoplasty
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, laser trabeculoplasty, intraocular pressure

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age < 60 years
  • Intraocular pressure not adequately controlled

Exclusion Criteria:

  • Prior laser treatment

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Argon laser trabeculoplasty

Selective laser trabeculoplasty

Arm Description

Patients received standard argon laser treatment

Patients received a standard selective laser treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 15, 2010
Last Updated
October 8, 2013
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01087684
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, laser trabeculoplasty, intraocular pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Argon laser trabeculoplasty
Arm Type
Active Comparator
Arm Description
Patients received standard argon laser treatment
Arm Title
Selective laser trabeculoplasty
Arm Type
Active Comparator
Arm Description
Patients received a standard selective laser treatment
Intervention Type
Procedure
Intervention Name(s)
Argon laser trabeculoplasty
Other Intervention Name(s)
ALT
Intervention Description
Argon laser 600-800 mW, 0.1seconds, 50 micron spot size, 45 - 55 burns over 180 degrees of trabecular meshwork
Intervention Type
Procedure
Intervention Name(s)
Selective laser trabeculoplasty
Other Intervention Name(s)
SLT
Intervention Description
Selective laser trabeculoplasty 0.7 - 0.8 mJ, 400 micron spot size, 3 nanosecond, 45 - 55 burns over 180 degrees of trabecular meshwork.
Primary Outcome Measure Information:
Title
Intraocular pressure
Description
The intraocular pressure was measured at 6 weeks, 4.5 months, 9, 12, 18 and 24 months following the laser treatment.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age < 60 years Intraocular pressure not adequately controlled Exclusion Criteria: Prior laser treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine M Birt, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21572334
Citation
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.
Results Reference
result

Learn more about this trial

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

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