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Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

Q

Queen's University

Status and phase

Withdrawn
Phase 1

Conditions

Glaucoma

Treatments

Procedure: Trabeculectomy without anterior chamber infusion system
Procedure: Trabeculectomy with anterior chamber infusion system

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

1
Experimental group
Description:
Trabeculectomy with anterior chamber infusion system
Treatment:
Procedure: Trabeculectomy with anterior chamber infusion system
2
Active Comparator group
Description:
Trabeculectomy without anterior chamber infusion system
Treatment:
Procedure: Trabeculectomy without anterior chamber infusion system

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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