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Sponsored by: |
Guy's and St Thomas' NHS Foundation Trust |
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Information provided by: | Guy's and St Thomas' NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT00719290 |
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 |
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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: | 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. |
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 |
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1: Active Comparator
Phacoemulsification with intraocular lens implant alone
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Procedure: Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Phacoemulsification of the lens with intraocular lens implant
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2: Active Comparator
Phacoemulsification with intraocular lens implant and goniosynechialysis
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Procedure: Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | K Sheng Lim, MB ChB MD FRCOpht | Guys ans St Thomas' NHS Trust |
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 |
Primary Angle Closure Glaucoma Phacoemulsification Goniosynechialysis Outflow facility |
Hyaluronic Acid Glaucoma Eye Diseases Cataract |
Glaucoma, Angle-Closure Hypertension Ocular Hypertension |
Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |