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Primary Angle Closure Glaucoma and Aqueous Dynamics
This study is currently recruiting participants.
Verified by Guy's and St Thomas' NHS Foundation Trust, July 2008
Sponsored by: Guy's and St Thomas' NHS Foundation Trust
Information provided by: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00719290
  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)

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Cataract Glaucoma
Drug Information available for: Hyaluronate Sodium Hyaluronic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Uncontrolled, Parallel Assignment, Efficacy Study
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.

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Intra- or post operative complications [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
  • Long-term PAS development [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Phacoemulsification with intraocular lens implant alone
Procedure: Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Phacoemulsification of the lens with intraocular lens implant
2: Active Comparator
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719290

Contacts
Contact: K Sheng Lim, MB ChB MD FRCOpht + 44 20 7188 9121 shenglim@gmail.com
Contact: Laura Beltran-Agullo, MBBS + 44 20 7188 9121 laurabeltragullo@gmail.com

Locations
United Kingdom
St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: K Sheng Lim, MB ChB MD FRCOpht     + 44 20 7188 9121        
Principal Investigator: K Sheng Lim, MB ChB MD FRCOpht            
Sub-Investigator: Rahat Husain, MBBS MRCOphth            
Sub-Investigator: Adanna Obi, MBBS MRCOphth            
Sub-Investigator: Laura Beltran-Agullo, MBBS            
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: Guy's and St Thomas' NHS Foundation Trust ( Mr K Sheng Lim, MB ChB MD FRCOphth )
Study ID Numbers: RJ1 08/0124
Study First Received: July 17, 2008
Last Updated: July 18, 2008
ClinicalTrials.gov Identifier: NCT00719290  
Health Authority: United Kingdom: National Health Service;   United Kingdom: Research Ethics Committee

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Primary Angle Closure Glaucoma
Phacoemulsification
Goniosynechialysis
Outflow facility

Study placed in the following topic categories:
Hyaluronic Acid
Glaucoma
Eye Diseases
Cataract
Glaucoma, Angle-Closure
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009