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Two Different Surgical Methods of Blepharospasm

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02765113
Enrollment
40
Registered
2016-05-06
Start date
2016-05-31
Completion date
2017-12-31
Last updated
2016-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blepharospasm

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.

Interventions

PROCEDUREFacial 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.

PROCEDUREFacial 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.

Sponsors

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Improvement of symptoms in patients with blepharospasmup to 12 monthsEvaluation of patients with blepharospasm by rating scale.

Secondary

MeasureTime frame
Incidence of facial numbnessup to 12 months
Incidence of facial paralysisup to 12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026