NCT00551902

Brief Summary

In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. The flow through the surgically created fistula determines the intraocular pressure. Titrating suture tightness is important to achieving the desired post-operative intraocular pressure. This process is not straightforward and intraocular pressures are often too high or too low post-operatively.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2007

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

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
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2.5 years

First QC Date

October 29, 2007

Last Update Submit

September 21, 2015

Conditions

Glaucoma

Keywords

Glaucomatrabeculectomyanterior chamber maintaineranterior chamber infusion

Outcome Measures

Primary Outcomes (1)

  • surgical success: intraocular pressure lowered by 30% and functional filtering bleb

    2 weeks, 1 month, 3 months, 6 months and 1 year post surgery

Secondary Outcomes (2)

  • Need for laser suture lysis

    any point post operatively

  • complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing

    any time post operatively

Study Arms (2)

1

EXPERIMENTAL

Trabeculectomy with anterior chamber infusion system

Procedure: Trabeculectomy with anterior chamber infusion system

2

ACTIVE COMPARATOR

Trabeculectomy without anterior chamber infusion system

Procedure: Trabeculectomy without anterior chamber infusion system

Interventions

Trabeculectomy with anterior chamber infusion systemPROCEDURE

Trabeculectomy with anterior chamber infusion system

1
Trabeculectomy without anterior chamber infusion systemPROCEDURE

Standard trabeculectomy surgery

2

Eligibility Criteria

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

You may qualify if:

  • years of age
  • One of the following diagnoses:
  • primary open angle glaucoma
  • chronic angle closure glaucoma
  • pseudo exfoliation glaucoma
  • pigment dispersion glaucoma

You may not qualify if:

  • unable to provide consent or return for follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hotel Dieu Hospital, Queen's University

Kingston, Ontario, K7L 5G2, Canada

Location

Toronto Western Hospital, University of Toronto

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Robert J Campbell, MD

    Queen's University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
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

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

CA(2)