Primary Angle Closure Glaucoma and Aqueous Dynamics
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| ClinicalTrials.gov Identifier: NCT00719290 |
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Recruitment Status :
Completed
First Posted : July 21, 2008
Last Update Posted : August 19, 2015
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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 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
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
Other Names:
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Active Comparator: 2
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
Other Names:
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- 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 ]
- 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 ]
- Intra- or post operative complications [ Time Frame: 2-3 weeks ]
- Long-term PAS development [ Time Frame: 1 year ]
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| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| United Kingdom | |
| St Thomas' Hospital | |
| London, United Kingdom, SE1 7EH | |
| Principal Investigator: | K Sheng Lim, MB ChB MD FRCOpht | Guys ans St Thomas' NHS Trust |
| Responsible Party: | KIN SHENG LIM, Consultant Ophthalmic Surgeon, Guy's and St Thomas' NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00719290 |
| 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 |
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Primary Angle Closure Glaucoma Phacoemulsification Goniosynechialysis Outflow facility |
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Glaucoma Glaucoma, Angle-Closure Ocular Hypertension Eye Diseases Hyaluronic Acid |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |