NCT01263561

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

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

April 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 9, 2014

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

4 years

First QC Date

December 14, 2010

Results QC Date

December 1, 2014

Last Update Submit

December 7, 2014

Conditions

Glaucoma

Keywords

glaucomafiltration surgerytrabeculectomyExPRESS shunt

Outcome Measures

Primary Outcomes (2)

  • Intraocular Pressure

    1 year post surgery

  • Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication

    1 year post surgery

Secondary Outcomes (1)

  • Complications

    1 year post surgery

Study Arms (2)

trabeculectomy

ACTIVE COMPARATOR

trabeculectomy filtering surgery

Procedure: trabeculectomy

ExPRESS

EXPERIMENTAL

ExPRESS miniature glaucoma drainage device

Procedure: ExPRESS shunt

Interventions

ExPRESS shuntPROCEDURE

ExPRESS miniature glaucoma drainage device

ExPRESS
trabeculectomyPROCEDURE

trabeculectomy filtering surgery

trabeculectomy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology and Vision Sciences Toronto Westarn Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 36912740DERIVED

  • 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.

    PMID: 26674779DERIVED

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Dr Yvonne Buys
Organization
Department of Ophthalmology and Vision Sciences, University of Toronto
y.buys@utoronto.ca
416-603-5682

Study Officials

  • Graham E Trope, Professor

    University of Toronto

    STUDY DIRECTOR

  • Yvonne M Buys, Professor

    University of Toronto

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCSC; Professor

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 20, 2010

Study Start

April 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 9, 2014

Results First Posted

December 9, 2014

Record last verified: 2014-12

Locations

CA(1)