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Completed

NCT Number: NCT00719290

Primary Angle Closure Glaucoma and Aqueous Dynamics

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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Key information

Conditions

Primary Angle Closure Eye Diseases Glaucoma Glaucoma, Angle-Closure Ocular Hypertension

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

Phacoemulsification of the lens with intraocular lens implant

Other names: Healon5, Acrylic Foldable Intraocular Lens (Acrysoft)

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

Procedure

Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis

Other names: Healon5, Acrylic Foldable Intraocular Lens (Acrysoft)

Primary outcomes

  1. 1. Outflow facility Success defined as increased outflow facility at 3 month compared to baseline with the same or reduced number of intraocular pressure lowering medications.

    Time frame: 3 months

Secondary outcomes

  1. 1. Intraocular pressure Success defined as decreased IOP at 3 month compared to baseline with the same or reduced number of intraocular pressure lowering medications

    Time frame: 3 months

  2. Intra- or post operative complications

    Time frame: 2-3 weeks

  3. Long-term PAS development

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

A Randomised Comparative Study of the Effects of Cataract Extraction With Lens Implant Alone Versus Cataract Extraction With Lens Implant and Goniosynechialysis on Outflow Facility in Patients With Primary Angle Closure Glaucoma.

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2008
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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