NCT00901108

Brief Summary

The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2009

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

5.4 years

First QC Date

May 11, 2009

Last Update Submit

February 23, 2016

Conditions

Open Angle Glaucoma

Keywords

open angle glaucomatrabectometrabeculectomycataract

Outcome Measures

Primary Outcomes (2)

  • Mean IOP at 6 months

    6 months

  • Surgical complication rates

    intraoperative and postoperative up to 12 months

Secondary Outcomes (6)

  • Mean difference in IOP from baseline to 6 months

    6 months

  • Mean IOP at 12 months

    12 months

  • Quality of life measures

    preoperative and postoperative at 6 and 12 months

  • Mean number of glaucoma medications

    12 months

  • Visual acuity

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Trabectome-IOL

ACTIVE COMPARATOR

Combined Trabectome and cataract extraction with intraocular lens insertion

Procedure: Trabectome-IOL

Trab-IOL

ACTIVE COMPARATOR

Combined Trabeculetomy with Mitomycin C and cataract extraction with intraocular lens insertion

Procedure: Trab-IOL

Interventions

Trabectome-IOLPROCEDURE

Trabectome removes an arc of trabecular meshwork and inner wall of Schlemm's canal to enhance aqueous outflow through natural drainage pathways. Trabectome will be done first, followed by cataract surgery because Trabectome requires a clear view through the cornea using a goniolens, and this view may be compromised after cataract surgery.

Trabectome-IOL
Trab-IOLPROCEDURE

Trabeculectomy bypasses the normal aqueous outflow channels of the eye and creates an external filtration pathway (called a filtering bleb) for aqueous to drain and be reabsorbed back into the circulation. Mitomycin C is an agent used during this procedure to decrease scar formation around the new passage. Cataract surgery will be done first, followed by Trabeculectomy with Mitomycin C.

Trab-IOL

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-85 years
  • Open angle glaucoma (including pseudo exfoliative glaucoma)
  • Open angles (≥ Shaffer grade II)
  • Inadequately controlled IOP requiring surgical intervention
  • Visually significant cataract
  • Willing to complete quality of life questionnaires
  • Capable of informed consent and available for at least 1 year follow-up

You may not qualify if:

  • Any form of angle closure glaucoma
  • Secondary open angle glaucomas
  • Absence of clear angle landmarks on gonioscopy
  • Other ocular disease that may affect assessments of visual acuity, visual field, or accurate tonometry
  • Previous angle surgery or filtering procedure
  • Steroid use within the preceding 3 months
  • Presence of significant co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Related Publications (2)

  • Hu K, Shah A, Virgili G, Bunce C, Gazzard G. Ab interno trabecular bypass surgery with Trabectome for open-angle glaucoma. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011693. doi: 10.1002/14651858.CD011693.pub3.

    PMID: 33580495DERIVED

  • Hu K, Gazzard G, Bunce C, Wormald R. Ab interno trabecular bypass surgery with Trabectome for open angle glaucoma. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD011693. doi: 10.1002/14651858.CD011693.pub2.

    PMID: 27526051DERIVED

MeSH Terms

Conditions

Glaucoma, Open-AngleCataract

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesLens Diseases

Study Officials

  • Karim F Damji, MD FRCSC MBA

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 13, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2015

Study Completion

October 1, 2015

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)