Primary Glaucoma Treatment Trial in Kenya and South Africa - SLT vs. Medication
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Intraocular pressure reduction
研究概览
简要总结
Multi-centre randomised controlled trial of selective laser trabeculoplasty compared with prostaglandin analogue therapy as primary treatment for high tension open angle glaucoma.
Participating centres are:
Institute of Ophthalmology, UCL, London, UK McCord Hospital, Durban, South Africa Innovation Eye Centre, Kisii, Kenya
详细描述
A debate continues concerning best first-line therapy for African primary open angle glaucoma. Most African practitioners advocate first line trabeculectomy surgery yet most frequently practice first line drug therapy because of patient acceptance and other issues. In the developed world a range of first line therapies including drug, SLT, cyclodiode ciliary body ablation, trabeculectomy surgery, drainage tube surgery and other drainage procedures (viscocanalostomy, non-penetrating surgery etc) have been advocated.
There is a paucity of good evidence concerning the relative merits of these approaches in an African context. The purpose of this study is to compare two approaches to first line therapy of primary open angle glaucoma in an African population.
Design A two centre randomised prospective trial of SLT vs. prostaglandin analogue first line therapy for primary open angle glaucoma.
Methods African patients with established or newly diagnosed primary open angle glaucoma or patients with POAG currently on single drug therapy (excluding prostaglandin analogues) and elevated IOP are recruited in Innovation Eye Centre in Kisii, Kenya and McCord Hospital, University of KwaZulu-Natal, Durban, South Africa. While if clinically indicated both eyes will be treated, one eye per patient to be included in the study.
After informed consent all patients undergo a standardised examination to establish baseline ocular function and findings. All patients receive counselling in glaucoma, the disease, what it means and the therapy. The patient is then randomised (randomisation in London, contained in sealed opaque envelopes) to receive SLT or prostaglandin analogue therapy. Every effort is made to follow all patients according to a standardised protocol at a minimum of month 3, month 6 and month 12. All therapeutic failures are followed closely to ascertain further management plans and subsequent therapeutic compliance. Follow-up is offered beyond 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •• Consent to inclusion and participation in trial.
- •Characteristic glaucomatous changes in the optic disc. The presence of a focal or diffuse area of optic disc rim loss, so that the neuroretinal rim tissue in any quadrant is less than 5% of the disc diameter in that meridian. Extensive loss of neuroretinal rim tissue with marked optic disc cupping giving a cup disc ratio greater than 0.
- •A measured intraocular pressure greater than or equal to 21 mmHg and less than or equal to 30mmHg on at least one visit before the time of entry into the study as measured by Goldmann applanation tonometry.
- •Adequate visualization of angle structures (i.e. clear media and cooperative patient)
- •Black African patients
排除标准
- •• Unwillingness to participate in the study
- •Inability/unwillingness to give informed consent
- •Unwillingness to accept randomisation
- •Patient less than 20 years of age
- •Anterior segment neovascularisation
- •Past trauma to the eye or ocular adnexae
- •Retinal or optic nerve neovascularisation
- •Aphakia or pseudophakia
- •Previous ocular surgery Evidence of ocular disease other than glaucoma that might affect the measurements of IOP, assessment of visual function, visual field testing would likely require cataract surgery within 12 months of randomization on systemic medications known to -IOP (e.g. steroids) Pregnancy or female of childbearing age who may be pregnant at time of treatment (LMP).
- •Anyone who is not Black African race
研究组 & 干预措施
Selective laser trabeculoplasty
Selective laser trabeculoplasty
干预措施: Selective laser trabeculoplasy (Procedure)
Selective laser trabeculoplasty
Selective laser trabeculoplasty
干预措施: laser (Device)
Prostaglandin analogue
Prostaglandin analogue topical medical therapy
干预措施: Prostaglandin analogue (Drug)
结局指标
主要结局
Intraocular pressure reduction
时间窗: 1 year
30% reduction complete 15-29% partial success
次要结局
- Compliance(1 year)
