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Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy

NCT ID: NCT01263561

Last Updated: 2014-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-04-30

Brief Summary

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Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome: IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from baseline without medication or additional glaucoma surgery and qualified success defined as IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.

Detailed Description

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Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.

Conditions

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Glaucoma

Keywords

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glaucoma filtration surgery trabeculectomy ExPRESS shunt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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trabeculectomy

trabeculectomy filtering surgery

Group Type ACTIVE_COMPARATOR

trabeculectomy

Intervention Type PROCEDURE

trabeculectomy filtering surgery

ExPRESS

ExPRESS miniature glaucoma drainage device

Group Type EXPERIMENTAL

ExPRESS shunt

Intervention Type PROCEDURE

ExPRESS miniature glaucoma drainage device

Interventions

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ExPRESS shunt

ExPRESS miniature glaucoma drainage device

Intervention Type PROCEDURE

trabeculectomy

trabeculectomy filtering surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age 18 to 85
* open-angle glaucoma uncontrolled medically
* intraocular pressure ≥ 18 mmHg
* trabeculectomy as the planned surgical procedure

Exclusion Criteria

* any previous ocular incisional surgery with the exception of previous clear
* cornea cataract surgery
* uveitis
* vitreous present in anterior chamber
* patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Yvonne Buys

MD, FRCSC; Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Graham E Trope, Professor

Role: STUDY_DIRECTOR

University of Toronto

Yvonne M Buys, Professor

Role: STUDY_DIRECTOR

University of Toronto

Locations

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Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.

Reference Type DERIVED
PMID: 36912740 (View on PubMed)

Gonzalez-Rodriguez JM, Trope GE, Drori-Wagschal L, Jinapriya D, Buys YM. Comparison of trabeculectomy versus Ex-PRESS: 3-year follow-up. Br J Ophthalmol. 2016 Sep;100(9):1269-73. doi: 10.1136/bjophthalmol-2015-307161. Epub 2015 Dec 16.

Reference Type DERIVED
PMID: 26674779 (View on PubMed)

Other Identifiers

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07-0888-A

Identifier Type: -

Identifier Source: org_study_id