Primary Angle Closure Glaucoma and Aqueous Dynamics

Primary Angle Closure Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719290
• Other study ID #: RJ1 08/0124
• Status: Completed
• Phase: N/A
• First received: July 17, 2008
• Last updated: August 18, 2015
• Start date: July 2008
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Angle-Closure
• Primary Angle Closure

Intervention

Procedure:
• Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Phacoemulsification of the lens with intraocular lens implant
• Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis

Locations

Country	Name	City	State
United Kingdom	St Thomas' Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months	No
Secondary	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		3 months	No
Secondary	Intra- or post operative complications		2-3 weeks	No
Secondary	Long-term PAS development		1 year	No