Effect of an Anterior Chamber Infusion System on Trabecul... | NCT00551902

Studies
Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

NCT00551902

Sponsor

Queen's University

Status

Withdrawn

Last Update Posted

Sep 23, 2015Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Glaucoma

Interventions

Trabeculectomy with anterior chamber infusion system
Trabeculectomy without anterior chamber infusion system

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Efficacy study indicated that further study is not warranted

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Oct 29, 2007

First Submission Date that Met QC Criteria

Oct 29, 2007

First Posted Date

Oct 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Name	Class
Glaucoma Research & Education Group	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The use of an anterior chamber infusion system to deliver fluid into the eye during trabeculectomy surgery may be of benefit in this process and may have other benefits as well which may result in better outcomes.

Thus, the hypothesis of this study is that the use of an anterior chamber infusion system improves success of trabeculectomy surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Trabeculectomy with anterior chamber infusion system	Procedure	Trabeculectomy with anterior chamber infusion system	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Need for laser suture lysis		any point post operatively
complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing		any time post operatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

unable to provide consent or return for follow up

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert J Campbell, MD	Queen's University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hotel Dieu Hospital, Queen's University		Kingston	Ontario	K7L 5G2	Canada
Toronto Western Hospital, University of Toronto

ID	Term
D005901	Glaucoma

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D014130	Trabeculectomy

Ancestor Terms

ID	Term
D018463	Filtering Surgery
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

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Browse Branches

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