Primary Angle Closure Glaucoma and Aqueous Dynamics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2015-08-31

Brief Summary

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The aim of the study is to determine which is the best treatment for people with cataract and primary angle closure (PAC).In PAC, apposition of the iris tissue to the drainage channels (Trabecular Meshwork-TM) of the eye results in damage and formation of adherences between these structures (Peripheral anterior synaechiae-PAS) causing a mechanical obstruction of the aqueous outflow via the TM. It is thought that cataract surgery combined with mechanical separation of the iris from the TM with the breakage of PAS(we call this separation 'goniosynechialysis') would make the pressure even lower as it would cause the drain to open to a greater extent than cataract surgery alone. This technique is not new, and the results have been very encouraging. Comparing this technique to cataract surgery alone however, has not been done and this is exactly what we would like to do in order to help us decide what is the best treatment.

In summary, the investigators propose that cataract surgery with goniosynechialysis would lower intraocular pressure to a greater extent than cataract surgery alone in patients with significant PAS.

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Detailed Description

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Conditions

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Primary Angle Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Phacoemulsification with intraocular lens implant alone

Group Type ACTIVE_COMPARATOR

Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)

Intervention Type PROCEDURE

Phacoemulsification of the lens with intraocular lens implant

2

Phacoemulsification with intraocular lens implant and goniosynechialysis

Group Type ACTIVE_COMPARATOR

Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)

Intervention Type PROCEDURE

Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis

Interventions

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Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)

Phacoemulsification of the lens with intraocular lens implant

Intervention Type PROCEDURE

Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)

Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis

Intervention Type PROCEDURE

Other Intervention Names

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Healon5 Acrylic Foldable Intraocular Lens (Acrysoft) Healon5 Acrylic Foldable Intraocular Lens (Acrysoft)

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 21 years.
* Diagnosis of PAC or PACG. PACG is defined as glaucomatous optic neuropathy in the opinion of a fellowship-trained glaucoma specialist, together with an IOP \> 21mmHg on at least one occasion, and reproducible visual field defect (using the 24-2 test pattern on a Humphrey Field Analyser). PAC has all the above characteristics except for the visual field defect.
* More than 90 degrees of PAS (not necessarily contiguous).
* Lens opacity deemed sufficient to be causing decreased vision in the opinion of the supervising consultant (KSL).
* Ability to give informed consent.

Exclusion Criteria

* Previous intraocular surgery or keratorefractive surgery.
* Previous eye trauma resulting in documented damage to the drainage angle (such as angle recession).
* History of uveitis.
* For patients on warfarin, INR \>3.0 on day of surgery.
* Anterior segment neovascularisation.
* Chronic use of topical or systemic steroids.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No