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
Recruitment status was Recruiting
Sponsor:
Guy's and St Thomas' NHS Foundation Trust
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
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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:
|
|
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:
|
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
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 |
ClinicalTrials.gov processed this record on May 23, 2013