Primary Angle Closure Glaucoma and Aqueous Dynamics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00719290
First received: July 17, 2008
Last updated: July 18, 2008
Last verified: July 2008
  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
Endpoint Classification: Efficacy Study
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:


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
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
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
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

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

No publications provided

Responsible Party: Mr K Sheng Lim, MB ChB MD FRCOphth, 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: July 18, 2008
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

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 30, 2014