Clinical trial NCT02765113: Two Different Surgical Methods of Blepharospasm
Official title: Effect of Two Different Surgical Methods on the Prognosis of Patients With Blepharospasm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Blepharospasm
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. 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.
2. Purpose：compare two different surgical methods, observe the improvement of symptoms and prognosis of patients with blepharospasm.
3. 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.
4. 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.
5. Expected results:To define a surgical method for the treatment of blepharospasm, and to promote the use of the academic and clinical practice.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with bilateral blepharospasm
2. Clinical symptoms more than 1 years.
3. Patients who are willing to undergo surgery.
4. Preoperative patients who had not been treated with botulinum toxin.

Exclusion Criteria:

1. Patients with serious heart and lung dysfunction can not tolerate surgery.
2. The clinical symptoms of the patients less than 1 years.
3. Patients who received local botulinum toxin treatment for a long time.
4. Patients with severe mental disorders.

Primary outcomes:
measure: Improvement of symptoms in patients with blepharospasm
timeFrame: up to 12 months
Secondary outcomes:
measure: Incidence of facial numbness
timeFrame: up to 12 months
measure: Incidence of facial paralysis
timeFrame: up to 12 months
Other outcomes:
Locations:
Study officials:
References: