NCT01087684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

4 years

First QC Date

March 15, 2010

Last Update Submit

October 8, 2013

Conditions

Glaucoma

Keywords

Glaucomalaser trabeculoplastyintraocular pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Argon laser trabeculoplasty

ACTIVE COMPARATOR

Patients received standard argon laser treatment

Procedure: Argon laser trabeculoplasty

Selective laser trabeculoplasty

ACTIVE COMPARATOR

Patients received a standard selective laser treatment

Procedure: Selective laser trabeculoplasty

Interventions

Argon laser trabeculoplastyPROCEDURE

Argon laser 600-800 mW, 0.1seconds, 50 micron spot size, 45 - 55 burns over 180 degrees of trabecular meshwork

Also known as: ALT
Argon laser trabeculoplasty
Selective laser trabeculoplastyPROCEDURE

Selective laser trabeculoplasty 0.7 - 0.8 mJ, 400 micron spot size, 3 nanosecond, 45 - 55 burns over 180 degrees of trabecular meshwork.

Also known as: SLT
Selective laser trabeculoplasty

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \< 60 years
  • Intraocular pressure not adequately controlled

You may not qualify if:

  • Prior laser treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related 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.

    PMID: 21572334RESULT

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Catherine M Birt, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 15, 2010

First Posted

March 16, 2010

Study Start

December 1, 2004

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

CA(1)