The China Laser and Surgery Study : A Mixed Methods Study With an Random Control Trial Comparing Outcomes From Selective Laser Trabeculoplasty Versus Surgical Treatment (Trabeculectomy) for Glaucoma in Rural China .
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Intraocular pressure
研究概览
简要总结
Aims and Objectives (Quantitative) Aim: To compare the effectiveness of selective laser trabeculoplasty with trabeculoplasty in lowering the intraocular pressure in patients with medically uncontrolled open angle glaucoma in rural China, taking into account the impact of patient acceptance of each type of treatment
Hypothesis: Mean intraocular pressure after treatment with selective laser trabeculoplasty will be lower than with surgery due to higher acceptance rates among patients randomized to receive this treatment and therefore treatment provided at an earlier stage of disease progression.
详细描述
Glaucoma is one of the three leading causes of blindness in China. Although this condition can be controlled with medication to lower intraocular pressure , such treatment must continue over a patient's lifetime. This is not practical in resource-poor settings due to cost and inconvenience for patients. Trabeculectomy is the standard treatment offered in rural China but is rarely used because of the following issues:
- need for hospitalization, which increases patient expense and inconvenience
- high refusal rates by patients for all ocular surgery
- high rates of infection due to poor quality instruments and material
- need for multiple follow-up visits post-surgery (our earlier work shows a return rate of only 30% 1 month post-surgery among rural patients in China).
A viable alternative for patients in rural China is selective laser trabeculoplasty , based on the following advantages:
- simplicity (done as a 5-minute out-patient procedure requiring only topical anaesthesia)
- effectiveness (18-32% reduction in intraocular pressure, which is comparable to medication)
- safety (complications are rare and do not include serious infectious as with trabeculotemy)
- convenience (minimal follow-up, with one visit within 6 weeks post-surgery)
- cost-effectiveness (compared to other glaucoma therapies in many settings)
- acceptability to patients (due to low-cost out-patient care with easy follow-up).
Study Design (Quantitative) This phase of the proposed China Laser and Surgery Study research project is a multi-centre open-label pragmatic randomised controlled trial.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of glaucoma (Cup to disk ratio, or CDR > 0.6 with optic nerve appearance and/or visual field findings consistent with glaucoma in the study eye)
- •angle configuration > 180° of trabecular meshwork visible in the study eye
- •no previous ocular incisional surgery or ocular laser treatment except refractive or cataract surgery in the study eye
- •Best corrected visual acuity > 6/60 metres in both eyes
排除标准
- •Intraocular pressure > 35 in the study eye
- •Cup to disk ratio > 0.9 in the study eye
- •Inability to give informed consent.
结局指标
主要结局
Intraocular pressure
时间窗: 12 months
* intraocular pressure in study eye 12 months after receiving treatment (laser or surgery) * the intraocular pressure of patients refusing their allocated intervention will still be recorded at 12 months post-refusal and will be considered in the analysis * patients accepting the allocated treatment \> 3 months after initial offer of treatment will be considered as having refused and their outcome intraocular pressure will be the last reading prior to treatment
次要结局
- Allocated treatment(12 months)
- Visual quality of life(12 months)
- Satisfaction score(12 months)
- Cataract surgery(12 months)
研究者
Congdon Nathan
vice directior
Sun Yat-sen University