Two Different Surgical Methods of Blepharospasm

Effect of Two Different Surgical Methods on the Prognosis of Patients With Blepharospasm

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.

Study Overview

• Status: Unknown
• Conditions: Blepharospasm
• Intervention / Treatment: Procedure: Facial nerve combing; Procedure: Facial and Trigeminal nerve combing

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Facial nerve combing; Facial nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.	Procedure: Facial nerve combing; Facial nerve combing:To sort out the facial nerve using the nerve combing knife. MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression.
Active Comparator: Facial and Trigeminal nerve combing; Facial nerve combing、trigeminal nerve combing and Microvascular Decompression(MVD) was performed in all the patients in this group.	Procedure: Facial and Trigeminal nerve combing; Facial nerve combing:To sort out the facial nerve using the nerve combing knife. Trigeminal nerve combing:To sort out the trigeminal nerve using the nerve combing knife. MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of symptoms in patients with blepharospasm	Evaluation of patients with blepharospasm by rating scale.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of facial numbness	up to 12 months
Incidence of facial paralysis	up to 12 months

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: May 4, 2016
• First Posted (Estimate): May 6, 2016

Study Record Updates

• Last Update Posted (Estimate): May 6, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharospasm
• Other Study ID Numbers: XH-16-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes