Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00551902

Enrollment

Registered

2007-10-31

Start date

2007-09-30

Completion date

2010-03-31

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Glaucoma, trabeculectomy, anterior chamber maintainer, anterior chamber infusion

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.

Interventions

PROCEDURETrabeculectomy with anterior chamber infusion system

Trabeculectomy with anterior chamber infusion system

PROCEDURETrabeculectomy without anterior chamber infusion system

Standard trabeculectomy surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026