Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Glaucoma Clinical Trial

Official title:

Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00551902
• Other study ID #: RC-2
• Status: Withdrawn
• Phase: Phase 1
• First received: October 29, 2007
• Last updated: September 21, 2015
• Start date: September 2007
• Est. completion date: March 2010

Study information

• Verified date: September 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Trabeculectomy with anterior chamber infusion system
Trabeculectomy with anterior chamber infusion system
• Trabeculectomy without anterior chamber infusion system
Standard trabeculectomy surgery

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital, Queen's University	Kingston	Ontario
Canada	Toronto Western Hospital, University of Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Glaucoma Research & Education Group

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical success: intraocular pressure lowered by 30% and functional filtering bleb		2 weeks, 1 month, 3 months, 6 months and 1 year post surgery	Yes
Secondary	Need for laser suture lysis		any point post operatively	Yes
Secondary	complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing		any time post operatively	Yes