Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion

NCT ID: NCT00551395

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-01-31

Brief Summary

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

Detailed Description

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SLT therapy is used as an IOP lowering agent in patients with glaucoma. It is unknown whether the timing of a 2-staged approach to the laser therapy will result in better IOP lowering effect.

This study will evaluate the timing (early vs. late completion of SLT therapy) and determined the IOP lowering effect following the interventions.

Arm 1: Early Completion SLT

180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees on Day 2

Arm 2: Late Completion SLT

180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees at the 1 month follow up visit.

Primary Outcome: IOP (mmHg).

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SLT Early Completion (Arm 1)

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

Group Type EXPERIMENTAL

selective laser trabeculoplasty - early completion

Intervention Type PROCEDURE

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

SLT Late Completion (Arm 2)

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

Group Type ACTIVE_COMPARATOR

Selective laser trabeculoplasty - late completion

Intervention Type PROCEDURE

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

Interventions

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selective laser trabeculoplasty - early completion

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

Intervention Type PROCEDURE

Selective laser trabeculoplasty - late completion

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age
* primary open angle glaucoma or pseudoexfoliation glaucoma

Exclusion Criteria

* Unable to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Robert Campbell

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert J Campbell, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Kingston, Canada

Locations

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Hotel Dieu Hospital & Queen's University

Kingston, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 35943114 (View on PubMed)

Other Identifiers

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RC-1

Identifier Type: -

Identifier Source: org_study_id

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