Primary Angle Closure Glaucoma and Aqueous Dynamics - Full Text View

Purpose

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.

Condition	Intervention
Primary Angle Closure	Procedure: Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) Procedure: Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Hyaluronic Acid Hyaluronate Sodium

U.S. FDA Resources

Further study details as provided by KIN SHENG LIM, Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:

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 Outcome Measures:

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 ]
Intra- or post operative complications [ Time Frame: 2-3 weeks ]
Long-term PAS development [ Time Frame: 1 year ]


Enrollment:	24
Study Start Date:	July 2008
Study Completion Date:	August 2015
Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Phacoemulsification with intraocular lens implant alone	Procedure: Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) Phacoemulsification of the lens with intraocular lens implant Other Names: Healon5 Acrylic Foldable Intraocular Lens (Acrysoft)
Active Comparator: 2 Phacoemulsification with intraocular lens implant and goniosynechialysis	Procedure: Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis Other Names: Healon5 Acrylic Foldable Intraocular Lens (Acrysoft)

Eligibility


Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719290

Locations


United Kingdom
St Thomas' Hospital
London, United Kingdom, SE1 7EH

Sponsors and Collaborators

Guy's and St Thomas' NHS Foundation Trust

Investigators


Principal Investigator:	K Sheng Lim, MB ChB MD FRCOpht	Guys ans St Thomas' NHS Trust

More Information


Responsible Party:	KIN SHENG LIM, Consultant Ophthalmic Surgeon, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:	NCT00719290 History of Changes
Other Study ID Numbers:	RJ1 08/0124
Study First Received:	July 17, 2008
Last Updated:	August 18, 2015

Keywords provided by KIN SHENG LIM, Guy's and St Thomas' NHS Foundation Trust:


Primary Angle Closure Glaucoma Phacoemulsification Goniosynechialysis Outflow facility

Additional relevant MeSH terms:


Glaucoma Glaucoma, Angle-Closure Ocular Hypertension Eye Diseases Hyaluronic Acid	Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents

ClinicalTrials.gov processed this record on June 26, 2017