Effect of Two Different Surgical Methods on the Prognosis of Patients With Blepharospasm
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 40
- 主要终点
- Improvement of symptoms in patients with blepharospasm
研究概览
简要总结
- Background: Blepharospasm refers to orbital and periorbital orbicularis muscle spontaneous spasmodic contraction. Continuous spasm can be long or short, the performance of non spasm will strongly closed repeatedly. At present, the pathogenesis of blepharospasm is not clear, in addition, there is no particularly effective treatment.
- Purpose：compare two different surgical methods, observe the improvement of symptoms and prognosis of patients with blepharospasm.
- Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open difficulties and the symptoms are worse when tension, anxiety, insomnia, light stimulation and wind outside stimulation. At the same time, in the clinic，the investigators found that facial nerve and trigeminal nerve combing can improve the clinical symptoms of the patients. Therefore, the investigators speculated that over activity were related to clinical symptoms and corneal reflex pathway of blepharospasm patients.
- Research content: the blepharospasm patients were randomly divided into two groups, prospective comparative analysis of two different surgical methods for the treatment of blepharospasm. One group of patients were performed facial nerve combing and microvascular decompression, the other group of patients were performed facial nerve, trigeminal nerve combing with microvascular decompression, to observation of postoperative clinical improvement of two groups of patients.
- Expected results:To define a surgical method for the treatment of blepharospasm, and to promote the use of the academic and clinical practice.
详细描述
Background: Blepharospasm refers to orbital and periorbital orbicularis muscle spontaneous spasmodic contraction. Continuous spasm can be long or short, the performance of non spasm will strongly closed repeatedly. At present, the pathogenesis of blepharospasm is not clear, in addition, there is no particularly effective treatment.
Purpose：compare two different surgical methods, observe the improvement of symptoms and prognosis of patients with blepharospasm.
Scientific hypothesis: At present, the pathogenesis of blepharospasm is not clear, but clinical patients with blepharospasm showed bilateral eyelid twitching, eyes open difficulties and the symptoms are worse when tension, anxiety, insomnia, light stimulation and wind outside stimulation. At the same time, in the clinic，the investigators found that facial nerve and trigeminal nerve combing can improve the clinical symptoms of the patients. Therefore, the investigators speculated that over activity were related to clinical symptoms and corneal reflex pathway of blepharospasm patients.
Research content: the blepharospasm patients were randomly divided into two groups, prospective comparative analysis of two different surgical methods for the treatment of blepharospasm. One group of patients were performed facial nerve combing and microvascular decompression, the other group of patients were performed facial nerve, trigeminal nerve combing with microvascular decompression, to observation of postoperative clinical improvement of two groups of patients.
Expected results:To define a surgical method for the treatment of blepharospasm, and to promote the use of the academic and clinical practice.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with bilateral blepharospasm
- •Clinical symptoms more than 1 years.
- •Patients who are willing to undergo surgery.
- •Preoperative patients who had not been treated with botulinum toxin.
排除标准
- •Patients with serious heart and lung dysfunction can not tolerate surgery.
- •The clinical symptoms of the patients less than 1 years.
- •Patients who received local botulinum toxin treatment for a long time.
- •Patients with severe mental disorders.
结局指标
主要结局
Improvement of symptoms in patients with blepharospasm
时间窗: up to 12 months
Evaluation of patients with blepharospasm by rating scale.
次要结局
- Incidence of facial numbness(up to 12 months)
- Incidence of facial paralysis(up to 12 months)