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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: 3 months
次要结局
- Intra- or post operative complications(2-3 weeks)
- 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(3 months)
- Long-term PAS development(1 year)
研究者
KIN SHENG LIM
Consultant Ophthalmic Surgeon
Guy's and St Thomas' NHS Foundation Trust