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Primary Angle Closure Glaucoma and Aqueous Dynamics

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ClinicalTrials.gov Identifier: NCT00719290
Recruitment Status : Completed
First Posted : July 21, 2008
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
KIN SHENG LIM, Guy's and St Thomas' NHS Foundation Trust

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment Phase
Primary Angle Closure Procedure: Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) Procedure: Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : July 2008
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 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