A Randomised Controlled Trial to Compare the Clinical Effectiveness of Selective Laser Trabeculoplasty (SLT) Versus Topical Therapy in the Treatment of Pseudoexfoliative Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of drops (and surgical interventions) needed to reach target IOP.
研究概览
简要总结
A number of large clinical trials have found pseudoexfoliation (PXF) to be a major risk factor for glaucoma progression and risk of blindness. It is estimated that PXF accounts for approximately a quarter of cases of open angle glaucoma in Nova Scotia, Canada, making this region an ideal setting for studying patients with this condition. Despite associated high morbidity, the treatment of pseudoexfoliative glaucoma remains suboptimal and a challenge for the clinician. Topical medical therapy is less effective than for primary open angle glaucoma and patients often require early surgical therapy, with associated risks. Selective laser trabeculoplasty (SLT) may be a safe and effective treatment for pseudoexfoliative glaucoma, although the evidence for this is presently lacking. The aim of the current study is to provide the first controlled-trial evidence for the effectiveness of SLT, compared to topical therapy, in the management of pseudoexfoliative glaucoma.
详细描述
Objectives:
The primary aim of this study is to compare the effectiveness, in terms of intraocular pressure (IOP) control, of SLT and topical medical therapy in the primary treatment of patients with high IOP secondary to PXF. The secondary aims of the study are:
- To examine the relationship between the degree of angle pigmentation and reduction of IOP
- To examine adverse effects from SLT treatment in patients with PXF
- To compare IOP-lowering effects of SLT in patients with PXF to patients with POAG (in the LiGHT study, see structure below).
Study Population: All new patients with PXF who are naïve to treatment (and willing to participate) will be recruited after their first hospital consultation. Both eyes will be treated but only one eye per patient included in the analysis (eye with the higher presenting IOP).
Structure: The study design mirrors that of National Institute of Health (NIHR-) funded, the laser in glaucoma and ocular hypertension trial (LiGHT) in the UK and is a collaborative study between a Canadian Institute and Moorfields Eye Hospital in London. This is a single-study randomised (unmasked) control trial of a proposed treatment intervention (SLT) versus a standard treatment (topical therapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of PXF material on the anterior chamber structures by slit lamp biomicroscopy.
- •An open drainage angle with no irido-trabecular contact on non-indentation gonioscopy in primary position trabecular meshwork visible over 360 degrees.
- •Ocular hypertension or glaucoma deemed to require treatment by the attending clinician.
- •A decision to treat has been made by a Consultant Glaucoma Specialist.
- •Age over 18 years and able to provide informed consent.
排除标准
- •Advanced glaucoma as determined by EMGT criteria 1: visual field loss mean deviation worse than -12 dB in the better or -15 dB in the worse eye.
- •Co-existing other secondary glaucoma (e.g. pigment dispersion syndrome, rubeosis etc) or angle closure glaucoma.
- •History of retinal ischaemia, macular oedema or diabetic retinopathy.
- •Age-related macular degeneration with neovascularisation or geographic atrophy and VA worse than 6/
- •Any previous intra-ocular surgery, except uncomplicated phacoemulsification at least one year before.* Medically unfit for completion of the trial.
研究组 & 干预措施
Laser pathway
Arm in which patients first randomised to receive SLT laser
干预措施: SLT Laser (Procedure)
Topical therapy
Arm in which patients first selected to receive drops (Prostagladin analogue as first-line)
干预措施: Prostagladin (Drug)
结局指标
主要结局
Number of drops (and surgical interventions) needed to reach target IOP.
时间窗: Change in IOP at 6 months, 12 months and 2 years (from baseline).
Percentage success
时间窗: At 6 months, 12 months and 2 years
Proportion of patients in whom SLT (or mono medical therapy) alone achieved target IOP.
次要结局
- Number of progressing patients in each study arm (SLT or medical therapy) in terms of visual field loss and HRT.(2 years)
- Comparison of percentage success and number of drops in current study with the equivalent results of patients with POAG in the LiGHT study(1 year and 2 years)
- Correlation of angle pigment grade with IOP reduction from SLT(6 months, 12 months, 2 years)