NCT00551395

Brief Summary

This study will evaluate the effect of the timing of treatment completion in two-staged selective laser trabeculoplasty therapy on intraocular pressure lowering effect.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

October 29, 2007

Last Update Submit

September 21, 2015

Conditions

Glaucoma

Keywords

glaucomalasertrabeculoplasty

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure lowering

    1 month following procedure

Secondary Outcomes (1)

  • intraocular pressure lowering

    3, 6, 12 and 24 months following procedure

Study Arms (2)

SLT Early Completion (Arm 1)

EXPERIMENTAL

Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degree on Day 2

Procedure: selective laser trabeculoplasty - early completion

SLT Late Completion (Arm 2)

ACTIVE COMPARATOR

Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degrees at 1 month follow up appointment.

Procedure: Selective laser trabeculoplasty - late completion

Interventions

selective laser trabeculoplasty - early completionPROCEDURE

180 degrees of laser on day 1 and other 180 degrees on day 2.

SLT Early Completion (Arm 1)
Selective laser trabeculoplasty - late completionPROCEDURE

180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point.

SLT Late Completion (Arm 2)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • primary open angle glaucoma or pseudoexfoliation glaucoma

You may not qualify if:

  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu Hospital & Queen's University

Kingston, Ontario, K7L 5G2, Canada

Location

Related Publications (1)

  • Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

    PMID: 35943114DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Robert J Campbell, MD

    Queen's University, Kingston, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 29, 2007

First Posted

October 31, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

CA(1)